comparsion of the effects of 3% Cichorium intybus L. hydroalcoholic extract gel vs diclofenac gel in the treatment of patients with primary monoarticular knee osteoarthritis who are taking celecoxib.
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Protocol summary
The aim of this study was to determine and compare the therapeutic effects of 3% gel of hydroalcoholic extract of Chicory and diclofenac in the treatment of knee joint primary osteoarthritis. Design: Double-blind, randomized clinical trials with placebo control. Population studied: patients with primary and knee joint osteoarthritis. Entrance criteria: age 80-40, weight 80-50kg, primary knee osteoarthritis, approved by radiological criteria in knee graphy, secondary osteoarthritis or suspicion, lack of liver and kidney disease, or any other underlying illness , Not having a history of allergies and allergies. Exit criteria: Primary osteoarthritis in both knees, skin diseases, or infection or ulcers at the place of topical use of the drug, the use of other topical drugs at the place of use, the use of aromatase inhibitors, oral administration of other analgesics and other Effective compounds in the treatment of osteoarthritis up to 10 days before the start of the study, arthralgia, pregnancy, lack of cooperation and the desire of the individual during the study to continue the company, causing any allergies or any problems during the intervention. Sample size: 150 people. Study Intervention: Salixib tablets are sacrificed 200 mg once a day, and 3% germs of chicory three times a day and each time for 3 to 5 minutes for 6 weeks are rubbed over the target area. Outcomes: The aim of this study was to compare the pain, morning dryness, dry daytime and physical function based on interviews, observation and standard WOMAC and VAS questionnaires in both control and intervention groups.
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The aim of this study was to determine and compare the therapeutic effects of 3% gel of hydroalcoholic extract of Chicory and diclofenac in the treatment of knee joint primary osteoarthritis. Design: Double-blind, randomized clinical trials with placebo control. Population studied: patients with primary and knee joint osteoarthritis. Entrance criteria: age 80-40, weight 80-50kg, primary knee osteoarthritis, approved by radiological criteria in knee graphy, secondary osteoarthritis or suspicion, lack of liver and kidney disease, or any other underlying illness , Not having a history of allergies and allergies. Exit criteria: Primary osteoarthritis in both knees, skin diseases, or infection or ulcers at the place of topical use of the drug, the use of other topical drugs at the place of use, the use of aromatase inhibitors, oral administration of other analgesics and other Effective compounds in the treatment of osteoarthritis up to 10 days before the start of the study, arthralgia, pregnancy, lack of cooperation and the desire of the individual during the study to continue the company, causing any allergies or any problems during the intervention. Sample size: 150 people. Study Intervention: Salixib tablets are sacrificed 200 mg once a day, and 3% germs of chicory three times a day and each time for 3 to 5 minutes for 6 weeks are rubbed over the target area. Outcomes: The aim of this study was to compare the pain, morning dryness, dry daytime and physical function based on interviews, observation and standard WOMAC and VAS questionnaires in both control and intervention groups.
هدف از مطالعه: تعیین و مقایسه اثرات درمانی ژل 3درصد عصاره هیدروالکلی گیاه کاسنی و دیکلوفناک در درمان استئوآرتریت اولیه تک مفصلی زانو. طراحی: کارآزمایی بالینی تصادفی شده دو سوکور، کنترل با دارونما می باشد. جمعیت مورد مطالعه: بیماران مبتلا به استئوآرتریت اولیه و تک مفصلی زانو. معیارهای ورود: سن 80-40 سال، وزن 80-50کیلوگرم، استئوآرتریت اولیه در یک زانو که با معیارهای رادیولوژیک در گرافی زانو مورد تأیید قرارگیرد، استئوآرتریت ثانویه یا شک به آن، عدم ابتلا به بیماری کبدی و کلیوی یا هر بیماری زمینه ای دیگر، نداشتن سابقه آلرژی و حساسیت. معیارهای خروج: استئوآرتریت اولیه در هر دو زانوی بیمار، بیماری های پوستی یا عفونت یا زخم در محل استفاده موضعی از دارو، استفاده از دیگر داروهای موضعی در محل استفاده از دارو، استفاده از داروهای مهارکننده آروماتاز، استفاده خوراکی از دیگر ضد دردها و دیگر ترکیبات مؤثر در درمان استئوآرتریت تا 10روز قبل از شروع مطالعه، بیماری های مادزادی مفصلی، حاملگی، عدم همکاری و تمایل فرد در حین مطالعه به ادامه شرکت، ایجاد هر گونه حساسیت و یا هرگونه مشکل حین انجام مداخله. حجم نمونه: 150نفر. مداخله مورد مطالعه: قرص سلکسیب 200 میلی گرم یک بار در روز خورده و ژل3 درصد کاسنی سه بار در روز و هر بار به مدت 3 تا 5 دقیقه به مدت 6 هفته روی ناحیه مورد نظر مالش داده می شود. پیامد مورد مطالعه: بررسی و مقایسه میزان درد، خشکی صبحگاهی، خشکی طول روز و عملکرد فیزیکی بر اساس مصاحبه، مشاهده و پرسشنامه های استاندارد WOMAC و VAS در دو گروه کنترل و مداخله.
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هدف از مطالعه: تعیین و مقایسه اثرات درمانی ژل 3درصد عصاره هیدروالکلی گیاه کاسنی و دیکلوفناک در درمان استئوآرتریت اولیه تک مفصلی زانو. طراحی: کارآزمایی بالینی تصادفی شده دو سوکور، کنترل با دارونما می باشد. جمعیت مورد مطالعه: بیماران مبتلا به استئوآرتریت اولیه و تک مفصلی زانو. معیارهای ورود: سن 80-40 سال، وزن 80-50کیلوگرم، استئوآرتریت اولیه در یک زانو که با معیارهای رادیولوژیک در گرافی زانو مورد تأیید قرارگیرد، استئوآرتریت ثانویه یا شک به آن، عدم ابتلا به بیماری کبدی و کلیوی یا هر بیماری زمینه ای دیگر، نداشتن سابقه آلرژی و حساسیت. معیارهای خروج: استئوآرتریت اولیه در هر دو زانوی بیمار، بیماری های پوستی یا عفونت یا زخم در محل استفاده موضعی از دارو، استفاده از دیگر داروهای موضعی در محل استفاده از دارو، استفاده از داروهای مهارکننده آروماتاز، استفاده خوراکی از دیگر ضد دردها و دیگر ترکیبات مؤثر در درمان استئوآرتریت تا 10روز قبل از شروع مطالعه، بیماری های مادزادی مفصلی، حاملگی، عدم همکاری و تمایل فرد در حین مطالعه به ادامه شرکت، ایجاد هر گونه حساسیت و یا هرگونه مشکل حین انجام مداخله. حجم نمونه: 150نفر. مداخله مورد مطالعه: قرص سلکسیب 200 میلی گرم یک بار در روز خورده و ژل3 درصد کاسنی سه بار در روز و هر بار به مدت 3 تا 5 دقیقه به مدت 6 هفته روی ناحیه مورد نظر مالش داده می شود. پیامد مورد مطالعه: بررسی و مقایسه میزان درد، خشکی صبحگاهی، خشکی طول روز و عملکرد فیزیکی بر اساس مصاحبه، مشاهده و پرسشنامه های استاندارد WOMAC و VAS در دو گروه کنترل و مداخله.
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Determine and compare the therapeutic effects of 3% gel of hydroalcoholic extract of Chicory and diclofenac in the treatment of knee joint primary osteoarthritis.
Determine and compare the therapeutic effects of 3% gel of hydroalcoholic extract of Chicory and diclofenac in the treatment of knee joint primary osteoarthritis.
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تعیین و مقایسه اثرات درمانی ژل 3درصد عصاره هیدروالکلی گیاه کاسنی و دیکلوفناک در درمان استئوآرتریت اولیه تک مفصلی زانو.
تعیین و مقایسه اثرات درمانی ژل 3درصد عصاره هیدروالکلی گیاه کاسنی و دیکلوفناک در درمان استئوآرتریت اولیه تک مفصلی زانو.
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Double-blind randomized clinical trial with parallel and control group
Double-blind randomized clinical trial with parallel and control group
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کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، دو سویه کور، تصادفی شده
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، دو سویه کور، تصادفی شده
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This study was performed on 150 patients with knee osteoarthritis referred to the orthopedic clinic. The patients were randomly distributed by selecting a card in one of 3 groups A, B, and C. The groups were identical in terms of age, gender and weight, and the patients and the researcher were unaware of the contents of the gel tubes. After 6 weeks of using the medications, the information was re-collected and compared with other groups and with the information before the start of the study.
This study was performed on 150 patients with knee osteoarthritis referred to the orthopedic clinic. The patients were randomly distributed by selecting a card in one of 3 groups A, B, and C. The groups were identical in terms of age, gender and weight, and the patients and the researcher were unaware of the contents of the gel tubes. After 6 weeks of using the medications, the information was re-collected and compared with other groups and with the information before the start of the study.
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این مطالعه بر روی 150 بیمار مبتلا به استئوآرتریت زانو مراجعه کننده به کلینیک ارتوپدی انجام شد. به روش تصادفی ساده بیماران با انتخاب یک کارت در یکی از 3 گروه A و B و C قرار گرفتند. گروه ها از نظر سن، جنس و وزن یکسان سازی شدند و بیماران و پژوهشگر از محتوای تیوب ژل ها بی خبر بودند. پس از 6 هفته استفاده از ژل ها اطلاعات، مجدد جمع آوری و با سایر گروه ها و قبل از شروع مطالعه مقایسه شد.
این مطالعه بر روی 150 بیمار مبتلا به استئوآرتریت زانو مراجعه کننده به کلینیک ارتوپدی انجام شد. به روش تصادفی ساده بیماران با انتخاب یک کارت در یکی از 3 گروه A و B و C قرار گرفتند. گروه ها از نظر سن، جنس و وزن یکسان سازی شدند و بیماران و پژوهشگر از محتوای تیوب ژل ها بی خبر بودند. پس از 6 هفته استفاده از ژل ها اطلاعات، مجدد جمع آوری و با سایر گروه ها و قبل از شروع مطالعه مقایسه شد.
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Inclusion criteria: age of 40-80 years, weight of 50-810 kgs, primary knee osteoarthritis approved by radiological criteria in knee graphy, secondary osteoarthritis or suspecting to it, lack of liver and kidney disease or any other underlying illness, Not having a history of allergies
Exclusion criteria: Primary osteoarthritis in both knees, Skin diseases or infection or ulcers at the place of topical use of the drug, Use of other topical drugs at the area, The use of aromatase inhibitors, Oral administration of other analgesics and other effective compounds in the treatment of osteoarthritis up to 10 days before the start of the study, Arthralgia, Pregnancy
Inclusion criteria: age of 40-80 years, weight of 50-810 kgs, primary knee osteoarthritis approved by radiological criteria in knee graphy, secondary osteoarthritis or suspecting to it, lack of liver and kidney disease or any other underlying illness, Not having a history of allergies Exclusion criteria: Primary osteoarthritis in both knees, Skin diseases or infection or ulcers at the place of topical use of the drug, Use of other topical drugs at the area, The use of aromatase inhibitors, Oral administration of other analgesics and other effective compounds in the treatment of osteoarthritis up to 10 days before the start of the study, Arthralgia, Pregnancy
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معیارهای ورود: سن 80-40 سال، وزن 80-50کیلوگرم، استئوآرتریت اولیه در یک زانو که با معیارهای رادیولوژیک در گرافی زانو مورد تأیید قرارگیرد، استئوآرتریت ثانویه یا شک به آن، عدم ابتلا به بیماری کبدی و کلیوی یا هر بیماری زمینه ای دیگر، نداشتن سابقه آلرژی و حساسیت. معیارهای عدم ورود: استئوآرتریت اولیه در هر دو زانوی بیمار، بیماری های پوستی یا عفونت یا زخم در محل استفاده موضعی از دارو، استفاده از دیگر داروهای موضعی در محل استفاده از دارو، استفاده از داروهای مهارکننده آروماتاز، استفاده خوراکی از دیگر ضد دردها و دیگر ترکیبات مؤثر در درمان استئوآرتریت تا 10روز قبل از شروع مطالعه، بیماری های مادرزادی مفصلی، حاملگی
معیارهای ورود: سن 80-40 سال، وزن 80-50کیلوگرم، استئوآرتریت اولیه در یک زانو که با معیارهای رادیولوژیک در گرافی زانو مورد تأیید قرارگیرد، استئوآرتریت ثانویه یا شک به آن، عدم ابتلا به بیماری کبدی و کلیوی یا هر بیماری زمینه ای دیگر، نداشتن سابقه آلرژی و حساسیت. معیارهای عدم ورود: استئوآرتریت اولیه در هر دو زانوی بیمار، بیماری های پوستی یا عفونت یا زخم در محل استفاده موضعی از دارو، استفاده از دیگر داروهای موضعی در محل استفاده از دارو، استفاده از داروهای مهارکننده آروماتاز، استفاده خوراکی از دیگر ضد دردها و دیگر ترکیبات مؤثر در درمان استئوآرتریت تا 10روز قبل از شروع مطالعه، بیماری های مادرزادی مفصلی، حاملگی
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Patients were divided into 3 groups receiving diclofenac and hydroalcoholic extract of chicory and placebo gel in addition to receiving celecoxib capsule.
Patients were divided into 3 groups receiving diclofenac and hydroalcoholic extract of chicory and placebo gel in addition to receiving celecoxib capsule.
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بیماران به 3 گروه دریافت کننده ژل دیکلوفناک و عصاره هیدروالکلی کاسنی و پلاسبو علاوه بر دریافت کپسول سلکسیب تقسیم شدند.
بیماران به 3 گروه دریافت کننده ژل دیکلوفناک و عصاره هیدروالکلی کاسنی و پلاسبو علاوه بر دریافت کپسول سلکسیب تقسیم شدند.
عملکرد فیزیکی؛ میزان درد زانو؛ میزان خشکی صبحگاهی؛ میزان خشکی طول روز
عملکرد فیزیکی؛ میزان درد زانو؛ میزان خشکی صبحگاهی؛ میزان خشکی طول روز
General information
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2017-12-11, 1396/09/20
2017-12-11 00:00:00
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2019-01-10, 1397/10/20
2019-01-10 00:00:00
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2019-02-14, 1397/11/25
2019-02-14 00:00:00
comparsion the effects of 3% Cichorium intybus L. hydroalcoholic extract gel vs diclofenac gel in the treatment of patient with primary monoarticular knee osteoarthritis In patients taking celecoxib.
comparsion of the effects of 3% Cichorium intybus L. hydroalcoholic extract gel vs diclofenac gel in the treatment of patients with primary monoarticular knee osteoarthritis who are taking celecoxib.
comparsion of the effects of 3% Cichorium intybus L. hydroalcoholic extract gel vs diclofenac gel in the treatment of patientpatients with primary monoarticular knee osteoarthritis In patientswho are taking celecoxib.
age of 40-80 years
weight of 50-80 kgs
primary osteoarthritis in one knee, confirmed by radiological criteria in knee graphy
secondary osteoarthritis or suspecting to it
lack of history of cognitive impairment
lack of Liver,kidney or any other underlying disease
having no history of allergies
age of 40-80 years weight of 50-80 kgs primary osteoarthritis in one knee, confirmed by radiological criteria in knee graphy secondary osteoarthritis or suspecting to it lack of history of cognitive impairment lack of Liver,kidney or any other underlying disease having no history of allergies
سن 80-40 سال
وزن 80-50کیلوگرم
استئوآرتریت اولیه در یک زانو که با معیارهای رادیولوژیک در گرافی زانو مورد تأیید قرارگیرد
استئوآرتریت ثانویه یا شک به آن
عدم داشتن سابقه اختلال شناختی
عدم ابتلا به بیماری کبدی و کلیوی یا هر بیماری زمینه ای دیگر
نداشتن سابقه آلرژی و حساسیت
سن 80-40 سال وزن 80-50کیلوگرم استئوآرتریت اولیه در یک زانو که با معیارهای رادیولوژیک در گرافی زانو مورد تأیید قرارگیرد استئوآرتریت ثانویه یا شک به آن عدم داشتن سابقه اختلال شناختی عدم ابتلا به بیماری کبدی و کلیوی یا هر بیماری زمینه ای دیگر نداشتن سابقه آلرژی و حساسیت
primary osteoarthritis in both knees
history of allergy to any form of anti-inflammatory drugs
skin diseases,infection or ulcers at the site of topical use of the drug
use of other topical drugs at the place of use of the drug
use of aromatase inhibitors
the oral administration of other analgesics and other compounds effective in the treatment of osteoarthritis up to 10 days before the start of the study
congenital joint diseases
pregnancy
lack of cooperation and desire of the individual during the study to continue the company
creation of any Sensitivity or any problem during the intervention
primary osteoarthritis in both knees history of allergy to any form of anti-inflammatory drugs skin diseases,infection or ulcers at the site of topical use of the drug use of other topical drugs at the place of use of the drug use of aromatase inhibitors the oral administration of other analgesics and other compounds effective in the treatment of osteoarthritis up to 10 days before the start of the study congenital joint diseases pregnancy lack of cooperation and desire of the individual during the study to continue the company creation of any Sensitivity or any problem during the intervention
استئوآرتریت اولیه در هر دو زانوی بیمار
سابقه حساسیت به هر یک از فرم های داروهای ضد التهابی
بیماری های پوستی یا عفونت یا زخم در محل استفاده موضعی از دارو
استفاده از دیگر داروهای موضعی در محل استفاده از دارو
استفاده از داروهای مهارکننده آروماتاز
استفاده خوراکی از دیگر ضد دردها و دیگر ترکیبات مؤثر در درمان استئوآرتریت تا 10 روز قبل از شروع مطالعه
بیماری های مادزادی مفصلی
حاملگی
عدم همکاری و تمایل فرد در حین مطالعه به ادامه شرکت
ایجاد هر گونه حساسیت و یا هر گونه مشکل حین انجام مداخله
استئوآرتریت اولیه در هر دو زانوی بیمار سابقه حساسیت به هر یک از فرم های داروهای ضد التهابی بیماری های پوستی یا عفونت یا زخم در محل استفاده موضعی از دارو استفاده از دیگر داروهای موضعی در محل استفاده از دارو استفاده از داروهای مهارکننده آروماتاز استفاده خوراکی از دیگر ضد دردها و دیگر ترکیبات مؤثر در درمان استئوآرتریت تا 10 روز قبل از شروع مطالعه بیماری های مادزادی مفصلی حاملگی عدم همکاری و تمایل فرد در حین مطالعه به ادامه شرکت ایجاد هر گونه حساسیت و یا هر گونه مشکل حین انجام مداخله
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Simple randomization was done using random numbers table and statistical software.
Simple randomization was done using random numbers table and statistical software.
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تصادفی سازی به روش ساده با استفاده از جدول اعداد تصادفی و نرم افزار آماری انجام شد.
تصادفی سازی به روش ساده با استفاده از جدول اعداد تصادفی و نرم افزار آماری انجام شد.
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The gel tubes were prepared by the pharmacist and were labeled A, B, and C. None of the patients and researchers knew about their content.
The gel tubes were prepared by the pharmacist and were labeled A, B, and C. None of the patients and researchers knew about their content.
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تیوب ژل ها توسط داروساز آماده و با حروف A و B و C نامگذاری شدند. هیچ یک از بیماران و محققان از محتوای آن ها خبر نداشتند.
تیوب ژل ها توسط داروساز آماده و با حروف A و B و C نامگذاری شدند. هیچ یک از بیماران و محققان از محتوای آن ها خبر نداشتند.
Primary outcomes
#1
WOMAC & VAS questionnaire
Western Ontario & McMaster Universities Osteoarthritis Index & Visual Analogue Scale questionnaire
پرسشنامه Western Ontario & McMaster Universities Osteoarthritis Index و Visual Analogue Scale
پرسشنامه WOMACWestern Ontario & McMaster Universities Osteoarthritis Index و VASVisual Analogue Scale
#2
WOMAC questionnaire
Western Ontario & McMaster Universities Osteoarthritis Index questionnaire
WOMACWestern Ontario & McMaster Universities Osteoarthritis Index questionnaire
پرسشنامه WOMAC
پرسشنامه Western Ontario & McMaster Universities Osteoarthritis Index
پرسشنامه WOMACWestern Ontario & McMaster Universities Osteoarthritis Index
#3
WOMAC questionnaire
Western Ontario & McMaster Universities Osteoarthritis Index questionnaire
WOMACWestern Ontario & McMaster Universities Osteoarthritis Index questionnaire
پرسشنامه WOMAC
پرسشنامه Western Ontario & McMaster Universities Osteoarthritis Index
پرسشنامه WOMACWestern Ontario & McMaster Universities Osteoarthritis Index
#4
WOMAC questionnaire
Western Ontario & McMaster Universities Osteoarthritis Index questionnaire
WOMACWestern Ontario & McMaster Universities Osteoarthritis Index questionnaire
پرسشنامه WOMAC
پرسشنامه Western Ontario & McMaster Universities Osteoarthritis Index
پرسشنامه WOMACWestern Ontario & McMaster Universities Osteoarthritis Index
Intervention groups
#1
Negative control group: Patients with knee joint primary osteoarthritis who take tablets of 200 mg once a day and gel containing the base of the gel (placebo) three times a day and for 3 to 5 minutes, 6 Weeks rub them over the area.
Negative control group: Patients with primary monoarticular osteoarthritis of knee joint who take 200 mg celecoxib tablets once a day and use the gel containing the base of the gel (placebo) three times a day each time for 3 to 5 minutes for 6 Weeks over the involved area.
Negative control group: Patients with primary monoarticular osteoarthritis of knee joint primary osteoarthritis who take tablets of 200 mg celecoxib tablets once a day and use the gel containing the base of the gel (placebo) three times a day andeach time for 3 to 5 minutes, for 6 Weeks rub them over the involved area.
#2
Positive control group: Patients with knee primary osteoarthritis who eat tablets of 200 mg once a day, once a day, and 1% diclofenac gel three times a day for 3 to 5 minutes and for 6 weeks rub on the area.
Positive control group: Patients with primary monoarticular osteoarthritis of knee joint who take 200 mg celecoxib tablets once a day, and use 1% diclofenac gel three times a day each time for 3 to 5 minutes for 6 weeks over the involved area.
Positive control group: Patients with knee primary monoarticular osteoarthritis of knee joint who eat tablets oftake 200 mg once a day,celecoxib tablets once a day, and use 1% diclofenac gel three times a day each time for 3 to 5 minutes and for 6 weeks rub onover the involved area.
#3
Intervention group: Patients with knee primary osteoarthritis who eat tablets of 200 mg once a day and 3% chicory gel three times a day for 3 to 5 minutes and 6 weeks on the target area They rub.
Intervention group: Patients with primary monoarticular osteoarthritis of knee joint who take 200 mg celecoxib tablets once a day and use 3% chicory gel three times a day for 3 to 5 minutes for 6 weeks over the involved area.
Intervention group: Patients with knee primary monoarticular osteoarthritis of knee joint who eat tablets oftake 200 mg celecoxib tablets once a day and use 3% chicory gel three times a day for 3 to 5 minutes andfor 6 weeks onover the targetinvolved area They rub.
Recruitment centers
#1
Name of recruitment center - English: Orthopedic office
Name of recruitment center - Persian: مطب ارتوپدی
Full name of responsible person - English: Dr. Morteza Dehghan (Associate Professor of Orthopedics)
Full name of responsible person - Persian: دکتر مرتضی دهقان(متخصص ارتوپدی، دانشیار)
Street address - English: Ground Floor, Kosar Passage, lower than Water Circle, Southern Moharram Twelve Street
Street address - Persian: خیابان دوازده محرم جنوبی، پایین تر از فلکه آبی، پاساژ کوثر، طبقه همکف
City - English: Shahrekord
City - Persian: شهرکرد
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Orthopedic office
Name of recruitment center - Persian: مطب ارتوپدی
Full name of responsible person - English: Dr. Morteza Dehghan (Associate Professor of Orthopedics)
Full name of responsible person - Persian: دکتر مرتضی دهقان(متخصص ارتوپدی، دانشیار)
Street address - English: Ground Floor, Kosar Passage, lower than abi square, Southern 12 Moharram Street
Street address - Persian: خیابان دوازده محرم جنوبی، پایین تر از فلکه آبی، پاساژ کوثر، طبقه همکف
City - English: Shahrekord
City - Persian: شهرکرد
Province: Chahar-Mahal-va-Bakhtiari
Country: Iran (Islamic Republic of)
Postal code: ۸۸۱۶۷۵۴۶۳۳
Phone: +98 38 3227 4004
Fax:
Email: dehghan_mortaza@yahoo.com
Web page address:
Name of recruitment center - English: Orthopedic office Name of recruitment center - Persian: مطب ارتوپدی Full name of responsible person - English: Dr. Morteza Dehghan (Associate Professor of Orthopedics) Full name of responsible person - Persian: دکتر مرتضی دهقان(متخصص ارتوپدی، دانشیار) Street address - English: Ground Floor, Kosar Passage, lower than Water Circleabi square, Southern 12 Moharram Twelve Street Street address - Persian: خیابان دوازده محرم جنوبی، پایین تر از فلکه آبی، پاساژ کوثر، طبقه همکف City - English: Shahrekord City - Persian: شهرکرد Province: Chahar-Mahal-va-Bakhtiari Country: Iran (Islamic Republic of) Postal code: ۸۸۱۶۷۵۴۶۳۳ Phone: +98 38 3227 4004 Fax: Email: dehghan_mortaza@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Shahrekord University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی شهرکرد
Full name of responsible person - English: Dr. seyed Kamal Solati(Associate Professor of Psychology)
Full name of responsible person - Persian: دکتر سید کمال صولتی(دانشیار روانشناسی)
Street address - English: Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
Street address - Persian: بلوار آیت الله کاشانی-ستاد دانشگاه -ساختمان شماره ۲ -معاونت پژوهشی
City - English: Shahrekord
City - Persian: شهرکرد
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Shahrekord University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی شهرکرد
Full name of responsible person - English: Dr. seyed Kamal Solati(Associate Professor of Psychology)
Full name of responsible person - Persian: دکتر سید کمال صولتی (دانشیار روانشناسی)
Street address - English: Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
Street address - Persian: بلوار آیت الله کاشانی-ستاد دانشگاه -ساختمان شماره ۲ -معاونت پژوهشی
City - English: Shahrekord
City - Persian: شهرکرد
Province: Chahar-Mahal-va-Bakhtiari
Country: Iran (Islamic Republic of)
Postal code: 8815713471
Phone: +98 38 3334 2414
Fax:
Email: kamal_solati@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research, Shahrekord University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی شهرکرد Full name of responsible person - English: Dr. seyed Kamal Solati(Associate Professor of Psychology) Full name of responsible person - Persian: دکتر سید کمال صولتی(دانشیارصولتی (دانشیار روانشناسی) Street address - English: Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd Street address - Persian: بلوار آیت الله کاشانی-ستاد دانشگاه -ساختمان شماره ۲ -معاونت پژوهشی City - English: Shahrekord City - Persian: شهرکرد Province: Chahar-Mahal-va-Bakhtiari Country: Iran (Islamic Republic of) Postal code: 8815713471 Phone: +98 38 3334 2414 Fax: Email: kamal_solati@yahoo.com Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Shahrekord University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شهرکرد
Full name of responsible person - English: Morteza Dehghan
Full name of responsible person - Persian: مرتضی دهقان
Position - English: Orthopedic
Position - Persian: ارتوپد
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
Street address - Persian: بلوار کاشانی، ستاد مرکزی، ساختمان شماره 2، دانشگاه علوم پزشکی شهرکرد
City - English: Shahrekord
City - Persian: شهرکرد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8815713471
Phone: +98 38 3227 4004
Mobile: +98 913 183 2044
Fax:
Email: dehghan_mortaza@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Shahrekord University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شهرکرد
Full name of responsible person - English: Morteza Dehghan
Full name of responsible person - Persian: مرتضی دهقان
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree: specialist
Area of specialty/work: 4
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
Street address - Persian: بلوار کاشانی، ستاد مرکزی، ساختمان شماره 2، دانشگاه علوم پزشکی شهرکرد
City - English: Shahrekord
City - Persian: شهرکرد
Province: Chahar-Mahal-va-Bakhtiari
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8815713471
Phone: +98 38 3227 4004
Mobile: +98 913 183 2044
Fax:
Email: dehghan_mortaza@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Shahrekord University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی شهرکرد Full name of responsible person - English: Morteza Dehghan Full name of responsible person - Persian: مرتضی دهقان Position - English: OrthopedicAssociate Professor Position - Persian: ارتوپددانشیار Latest degree: specialist Area of specialty/work: 04 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd Street address - Persian: بلوار کاشانی، ستاد مرکزی، ساختمان شماره 2، دانشگاه علوم پزشکی شهرکرد City - English: Shahrekord City - Persian: شهرکرد Province: Chahar-Mahal-va-Bakhtiari Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8815713471 Phone: +98 38 3227 4004 Mobile: +98 913 183 2044 Fax: Email: dehghan_mortaza@yahoo.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Shahrekord University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شهرکرد
Full name of responsible person - English: Morteza Dehghan
Full name of responsible person - Persian: مرتضی دهقان
Position - English: Orthopedic
Position - Persian: ارتوپد
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
Street address - Persian: بلوار کاشانی، ستاد مرکزی دانشگاه، ساختمان شماره 2، دانشگاه علوم پزشکی شهرکرد
City - English: Shahrekord
City - Persian: شهرکرد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8815713471
Phone: +98 38 3227 4004
Mobile: +98 913 183 2044
Fax:
Email: dehghan_mortaza@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Shahrekord University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شهرکرد
Full name of responsible person - English: Morteza Dehghan
Full name of responsible person - Persian: مرتضی دهقان
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree: specialist
Area of specialty/work: 4
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
Street address - Persian: بلوار کاشانی، ستاد مرکزی دانشگاه، ساختمان شماره 2، دانشگاه علوم پزشکی شهرکرد
City - English: Shahrekord
City - Persian: شهرکرد
Province: Chahar-Mahal-va-Bakhtiari
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8815713471
Phone: +98 38 3227 4004
Mobile: +98 913 183 2044
Fax:
Email: dehghan_mortaza@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Shahrekord University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی شهرکرد Full name of responsible person - English: Morteza Dehghan Full name of responsible person - Persian: مرتضی دهقان Position - English: OrthopedicAssociate Professor Position - Persian: ارتوپددانشیار Latest degree: specialist Area of specialty/work: 04 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd Street address - Persian: بلوار کاشانی، ستاد مرکزی دانشگاه، ساختمان شماره 2، دانشگاه علوم پزشکی شهرکرد City - English: Shahrekord City - Persian: شهرکرد Province: Chahar-Mahal-va-Bakhtiari Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8815713471 Phone: +98 38 3227 4004 Mobile: +98 913 183 2044 Fax: Email: dehghan_mortaza@yahoo.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Shahrekord University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شهرکرد
Full name of responsible person - English: Morteza Dehghan
Full name of responsible person - Persian: مرتضی دهقان
Position - English: Orthopedic
Position - Persian: ارتوپد
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
Street address - Persian: بلوار کاشانی، ستاد مرکزی دانشگاه، ساختمان شماره2، دانشگاه علوم پزشکی شهرکرد
City - English: Shahrekord
City - Persian: شهرکرد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 38 3227 4004
Mobile: +98 913 183 2044
Fax:
Email: dehghan_mortaza@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Shahrekord University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شهرکرد
Full name of responsible person - English: Morteza Dehghan
Full name of responsible person - Persian: مرتضی دهقان
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree: specialist
Area of specialty/work: 4
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
Street address - Persian: بلوار کاشانی، ستاد مرکزی دانشگاه، ساختمان شماره2، دانشگاه علوم پزشکی شهرکرد
City - English: Shahrekord
City - Persian: شهرکرد
Province: Chahar-Mahal-va-Bakhtiari
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8815713471
Phone: +98 38 3227 4004
Mobile: +98 913 183 2044
Fax:
Email: dehghan_mortaza@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Shahrekord University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی شهرکرد Full name of responsible person - English: Morteza Dehghan Full name of responsible person - Persian: مرتضی دهقان Position - English: OrthopedicAssociate Professor Position - Persian: ارتوپددانشیار Latest degree: specialist Area of specialty/work: 04 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd Street address - Persian: بلوار کاشانی، ستاد مرکزی دانشگاه، ساختمان شماره2، دانشگاه علوم پزشکی شهرکرد City - English: Shahrekord City - Persian: شهرکرد Province: Chahar-Mahal-va-Bakhtiari Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8815713471 Phone: +98 38 3227 4004 Mobile: +98 913 183 2044 Fax: Email: dehghan_mortaza@yahoo.com Web page address:
Sharing plan
yes
yes
yes
yes
no
no
undecided
undecided
yes
yes
no
no
no
no
empty
Information about the main outcome can be shared.
Information about the main outcome can be shared.
empty
اطلاعات مربوط به پیامد اصلی امکان اشتراک گذاری دارد.
اطلاعات مربوط به پیامد اصلی امکان اشتراک گذاری دارد.
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Start the access period 4 months after publishing the results
Start the access period 4 months after publishing the results
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شروع دوره دسترسی 4ماه پس از چاپ نتایج
شروع دوره دسترسی 4ماه پس از چاپ نتایج
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Researchers working in academia
Researchers working in academia
empty
محققین شاغل در موسسات دانشگاهی و علمی
محققین شاغل در موسسات دانشگاهی و علمی
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Use data to complete clinical trial studies
Use data to complete clinical trial studies
empty
استفاده از داده ها برای کامل کردن مطالعات بالینی
استفاده از داده ها برای کامل کردن مطالعات بالینی
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Kashani Hospital in Shahrekord, dehghan_mortaza@yahoo.com
Kashani Hospital in Shahrekord, dehghan_mortaza@yahoo.com
after the investigation of resercher request and presentation of required documents will be accessible.
after the investigation of resercher request and presentation of required documents will be accessible.
empty
با بررسی درخواست محقق و ارائه مستندات کافی از تحقیق خود و علت استفاده از داده ها قابل ارائه خواهد بود.
با بررسی درخواست محقق و ارائه مستندات کافی از تحقیق خود و علت استفاده از داده ها قابل ارائه خواهد بود.
Protocol summary
Study aim
Determine and compare the therapeutic effects of 3% gel of hydroalcoholic extract of Chicory and diclofenac in the treatment of knee joint primary osteoarthritis.
Design
Double-blind randomized clinical trial with parallel and control group
Settings and conduct
This study was performed on 150 patients with knee osteoarthritis referred to the orthopedic clinic. The patients were randomly distributed by selecting a card in one of 3 groups A, B, and C. The groups were identical in terms of age, gender and weight, and the patients and the researcher were unaware of the contents of the gel tubes. After 6 weeks of using the medications, the information was re-collected and compared with other groups and with the information before the start of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age of 40-80 years, weight of 50-810 kgs, primary knee osteoarthritis approved by radiological criteria in knee graphy, secondary osteoarthritis or suspecting to it, lack of liver and kidney disease or any other underlying illness, Not having a history of allergies
Exclusion criteria: Primary osteoarthritis in both knees, Skin diseases or infection or ulcers at the place of topical use of the drug, Use of other topical drugs at the area, The use of aromatase inhibitors, Oral administration of other analgesics and other effective compounds in the treatment of osteoarthritis up to 10 days before the start of the study, Arthralgia, Pregnancy
Intervention groups
Patients were divided into 3 groups receiving diclofenac and hydroalcoholic extract of chicory and placebo gel in addition to receiving celecoxib capsule.
Vice chancellor for research, Shahrekord University of Medical Sciences
Expected recruitment start date
2017-12-03, 1396/09/12
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
2017-12-11, 1396/09/20
Actual recruitment end date
2019-01-10, 1397/10/20
Trial completion date
2019-02-14, 1397/11/25
Scientific title
comparsion of the effects of 3% Cichorium intybus L. hydroalcoholic extract gel vs diclofenac gel in the treatment of patients with primary monoarticular knee osteoarthritis who are taking celecoxib.
Public title
Chicory gel effect on the treatment of osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age of 40-80 years
weight of 50-80 kgs
primary osteoarthritis in one knee, confirmed by radiological criteria in knee graphy
secondary osteoarthritis or suspecting to it
lack of history of cognitive impairment
lack of Liver,kidney or any other underlying disease
having no history of allergies
Exclusion criteria:
primary osteoarthritis in both knees
history of allergy to any form of anti-inflammatory drugs
skin diseases,infection or ulcers at the site of topical use of the drug
use of other topical drugs at the place of use of the drug
use of aromatase inhibitors
the oral administration of other analgesics and other compounds effective in the treatment of osteoarthritis up to 10 days before the start of the study
congenital joint diseases
pregnancy
lack of cooperation and desire of the individual during the study to continue the company
creation of any Sensitivity or any problem during the intervention
Age
From 40 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
150
Actual sample size reached:
144
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization was done using random numbers table and statistical software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The gel tubes were prepared by the pharmacist and were labeled A, B, and C. None of the patients and researchers knew about their content.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713492
Approval date
2017-10-29, 1396/08/07
Ethics committee reference number
IR.SKUMS.REC.1396.154
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17.1
ICD-10 code description
Other primary gonarthrosis
Primary outcomes
1
Description
Knee pain
Timepoint
Before intervention, 6 weeks after intervention
Method of measurement
Western Ontario & McMaster Universities Osteoarthritis Index & Visual Analogue Scale questionnaire
2
Description
daytime stiffness
Timepoint
Before intervention, 6 weeks after intervention
Method of measurement
Western Ontario & McMaster Universities Osteoarthritis Index questionnaire
3
Description
Morning stiffness
Timepoint
Before intervention, 6 weeks after intervention
Method of measurement
Western Ontario & McMaster Universities Osteoarthritis Index questionnaire
4
Description
Physical performance
Timepoint
Before intervention, 6 weeks after intervention
Method of measurement
Western Ontario & McMaster Universities Osteoarthritis Index questionnaire
Secondary outcomes
1
Description
Skin allergy
Timepoint
Six weeks after the intervention
Method of measurement
Observation and examination
Intervention groups
1
Description
Negative control group: Patients with primary monoarticular osteoarthritis of knee joint who take 200 mg celecoxib tablets once a day and use the gel containing the base of the gel (placebo) three times a day each time for 3 to 5 minutes for 6 Weeks over the involved area.
Category
Placebo
2
Description
Positive control group: Patients with primary monoarticular osteoarthritis of knee joint who take 200 mg celecoxib tablets once a day, and use 1% diclofenac gel three times a day each time for 3 to 5 minutes for 6 weeks over the involved area.
Category
Treatment - Drugs
3
Description
Intervention group: Patients with primary monoarticular osteoarthritis of knee joint who take 200 mg celecoxib tablets once a day and use 3% chicory gel three times a day for 3 to 5 minutes for 6 weeks over the involved area.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthopedic office
Full name of responsible person
Dr. Morteza Dehghan (Associate Professor of Orthopedics)
Street address
Ground Floor, Kosar Passage, lower than abi square, Southern 12 Moharram Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۷۵۴۶۳۳
Phone
+98 38 3227 4004
Email
dehghan_mortaza@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahrekord University of Medical Sciences
Full name of responsible person
Dr. seyed Kamal Solati(Associate Professor of Psychology)
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
kamal_solati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahrekord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Morteza Dehghan
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3227 4004
Fax
Email
dehghan_mortaza@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Morteza Dehghan
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3227 4004
Fax
Email
dehghan_mortaza@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Morteza Dehghan
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3227 4004
Fax
Email
dehghan_mortaza@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period 4 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
Kashani Hospital in Shahrekord, dehghan_mortaza@yahoo.com
What processes are involved for a request to access data/document
after the investigation of resercher request and presentation of required documents will be accessible.