The effects of curcumin supplementation along with manual therapy on Metabolic Parameters, Inflammatory Markers, Oxidative Stress, and Electromyography in Frozen Shoulder Patients: A Randomized Clinical Trial
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Protocol summary
Eligible people will be selected with the approval of a orthopedic specialist and will enter the study with full consent. The duration of supplemental is 12 weeks. Blood samples will be taken from all patients to determine and compare the effect of curcumin-piperine and manual therapy or manual therapy on biochemical indicators. All patients are asked to return unused supplements at each visit.
Eligible people will be selected with the approval of a orthopedic specialist and will enter the study with full consent. The duration of supplemental is 2 weeks. Blood samples will be taken from all patients to determine and compare the effect of curcumin-piperine and manual therapy or manual therapy on biochemical indicators. All patients are asked to return unused supplements at each visit.
Eligible people will be selected with the approval of a orthopedic specialist and will enter the study with full consent. The duration of supplemental is 122 weeks. Blood samples will be taken from all patients to determine and compare the effect of curcumin-piperine and manual therapy or manual therapy on biochemical indicators. All patients are asked to return unused supplements at each visit.
افراد واجد شرایط با تایید متخصص ارتوپدی انتخاب و با رضایت کامل وارد مطالعه خواهند شد. مدت مصرف مکمل 12 هفته است. برای تعیین و مقایسه اثر کورکومین-پیپرین و درمان دستی یا درمان دستی بر شاخص های بیوشیمیایی از همه بیماران نمونه خون گرفته خواهد شد. از همه بیماران خواسته می شود در هر ویزیت مکمل های مصرف نشده را برگردانند.
افراد واجد شرایط با تایید متخصص ارتوپدی انتخاب و با رضایت کامل وارد مطالعه خواهند شد. مدت مصرف مکمل 2 هفته است. برای تعیین و مقایسه اثر کورکومین-پیپرین و درمان دستی یا درمان دستی بر شاخص های بیوشیمیایی از همه بیماران نمونه خون گرفته خواهد شد. از همه بیماران خواسته می شود در هر ویزیت مکمل های مصرف نشده را برگردانند.
افراد واجد شرایط با تایید متخصص ارتوپدی انتخاب و با رضایت کامل وارد مطالعه خواهند شد. مدت مصرف مکمل 122 هفته است. برای تعیین و مقایسه اثر کورکومین-پیپرین و درمان دستی یا درمان دستی بر شاخص های بیوشیمیایی از همه بیماران نمونه خون گرفته خواهد شد. از همه بیماران خواسته می شود در هر ویزیت مکمل های مصرف نشده را برگردانند.
Inclusion Criteria: Patients diagnosed with frozen shoulder by an orthopedic specialist, aged between 20 and 65 years, who are willing to participate in the study. Exclusion Criteria: Individuals suffering from other skeletal diseases, those who have shown reactions or sensitivities to the prescribed supplement, individuals who fail to attend various stages of the study, and smokers
Inclusion Criteria: Patients diagnosed with frozen shoulder by an orthopedic specialist, aged between 20 and 65 years, who are willing to participate in the study. Exclusion criteria include non-compliance with supplement guidelines, adverse reactions, failure to attend study phases, bone and muscular disorders, worsening pain and joint limitations, smoking, and consumption of interfering nutritional supplements. Also excluded are individuals with inflammatory diseases (such as rheumatoid arthritis, osteoarthritis, lupus), skeletal, or muscular conditions in the neck and upper limbs, and related disorders like rotator cuff syndrome and disc inflammation in the cervical spine.
Inclusion Criteria: Patients diagnosed with frozen shoulder by an orthopedic specialist, aged between 20 and 65 years, who are willing to participate in the study. Exclusion Criteria: Individuals suffering from other skeletal diseasescriteria include non-compliance with supplement guidelines, those who have shownadverse reactions or sensitivities to the prescribed supplement, individuals who failfailure to attend various stages of the study phases, bone and muscular disorders, worsening pain and joint limitations, smoking, and smokersconsumption of interfering nutritional supplements. Also excluded are individuals with inflammatory diseases (such as rheumatoid arthritis, osteoarthritis, lupus), skeletal, or muscular conditions in the neck and upper limbs, and related disorders like rotator cuff syndrome and disc inflammation in the cervical spine.
معیارهای ورود: بیماران مبتلا به شانه یخ زده که بیماری آنها توسط متخصص ارتوپدی تشخیص داده شده است، سن بین 20 تا 65 سال، و بیمارانی که تمایل به شرکت در مطالعه دارند. معیارهای عدم ورود: افرادی که از سایر بیماری های اسکلتی رنج می برند، افرادی که نسبت به مکمل تجویز شده واکنش یا حساسیت نشان دهند، افرادی که در مراحل مختلف مطالعه شرکت نکنند و افراد سیگاری
معیارهای ورود: بیماران مبتلا به شانه یخ زده که بیماری آنها توسط متخصص ارتوپدی تشخیص داده شده است، سن بین 20 تا 65 سال، و بیمارانی که تمایل به شرکت در مطالعه دارند. معیارهای عدم ورود شامل موارد زیر است: عدم رعایت دستورالعملهای مصرف مکمل، واکنشهای نامطلوب، عدم حضور در مراحل مطالعه، بیماریهای استخوانی و عضلانی (مانند پوکی استخوان)، افزایش درد و محدودیت بیشتر در عملکرد مفصل، استعمال دخانیات، و مصرف مکملهای تغذیهای تداخلکننده. همچنین، افراد مبتلا به بیماریهای التهابی (مانند آرتریت روماتوئید، استئوآرتریت، لوپوس، و بیماریهای التهابی روده)، اختلالات اسکلتی، عصبی، یا عضلانی در ناحیه گردن و اندامهای فوقانی، و بیماریهای مرتبط مانند سندروم روتاتورکاف و التهاب دیسکهای گردنی (C4 و C5) نیز از مطالعه مستثنی میشوند.
معیارهای ورود: بیماران مبتلا به شانه یخ زده که بیماری آنها توسط متخصص ارتوپدی تشخیص داده شده است، سن بین 20 تا 65 سال، و بیمارانی که تمایل به شرکت در مطالعه دارند. معیارهای عدم ورود شامل موارد زیر است: افرادی که از سایر بیماری عدم رعایت دستورالعملهای اسکلتی رنج می برندمصرف مکمل، افرادی که نسبت به مکمل تجویز شده واکنش یا حساسیت نشان دهندهای نامطلوب، افرادی کهعدم حضور در مراحل مختلفمطالعه، بیماریهای استخوانی و عضلانی (مانند پوکی استخوان)، افزایش درد و محدودیت بیشتر در عملکرد مفصل، استعمال دخانیات، و مصرف مکملهای تغذیهای تداخلکننده. همچنین، افراد مبتلا به بیماریهای التهابی (مانند آرتریت روماتوئید، استئوآرتریت، لوپوس، و بیماریهای التهابی روده)، اختلالات اسکلتی، عصبی، یا عضلانی در ناحیه گردن و اندامهای فوقانی، و بیماریهای مرتبط مانند سندروم روتاتورکاف و التهاب دیسکهای گردنی (C4 و C5) نیز از مطالعه شرکت نکنند و افراد سیگاریمستثنی میشوند.
The subjects of the intervention group, will recieve one curcumin piperine capsule daily (containing 500 mg of curcumin extract and 5 mg of piperine) along with manual therapy (4 sessions) for 14 days and the control group will recieve manual therapy (4 sessions) for 14 days.
The subjects of the intervention group, will recieve one curcumin piperine capsule daily (containing 500 mg of curcumin extract and 5 mg of piperine) along with manual therapy (3 sessions per week)for 14 days and the control group will recieve manual therapy (3 sessions per week) for 14 days.
The subjects of the intervention group, will recieve one curcumin piperine capsule daily (containing 500 mg of curcumin extract and 5 mg of piperine) along with manual therapy (43 sessions) for per week)for 14 days and the control group will recieve manual therapy (43 sessions per week) for 14 days.
دریافت روزانه یک کپسول حاوی کورکومین پیپرین (حاوی 500 میلی گرم عصاره کورکومین و 5 میلی گرم پیپرین) همراه با دست درمانی (4 جلسه) به مدت 14 روز، گروه کنترل: دریافت دست درمانی (4 جلسه) به مدت 14 روز.
دریافت روزانه یک کپسول حاوی کورکومین پیپرین (حاوی 500 میلی گرم عصاره کورکومین و 5 میلی گرم پیپرین) همراه با دست درمانی (3 جلسه در هفته) به مدت 14 روز، گروه کنترل: دریافت دست درمانی (3 جلسه در هفته) به مدت 14 روز.
دریافت روزانه یک کپسول حاوی کورکومین پیپرین (حاوی 500 میلی گرم عصاره کورکومین و 5 میلی گرم پیپرین) همراه با دست درمانی (43 جلسه در هفته) به مدت 14 روز، گروه کنترل: دریافت دست درمانی (43 جلسه در هفته) به مدت 14 روز.
General information
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Typographical errors and omission of several important point
Typographical errors and omission of several important point
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علت اصلاح این بخش اشتباه نگارشی و از قلم افتادن چند مورد مهم می باشد.
علت اصلاح این بخش اشتباه نگارشی و از قلم افتادن چند مورد مهم می باشد.
Not attending follow-up appointments during various phases of the study
Reaction and sensitivity to the prescribed supplement
Non-compliance with recommendations and nutritional supplements
Intensification of pain and more limitation in joint function
Inflammatory diseases such as rheumatoid arthritis, osteoarthritis and lupus
Patients with other skeletal, nervous, muscular diseases in the neck and upper limbs
Not attending follow-up appointments during various phases of the study
Reaction and sensitivity to the prescribed supplement
Non-compliance with recommendations and nutritional supplements
Intensification of pain and more limitation in joint function
Inflammatory diseases such as rheumatoid arthritis, osteoarthritis and lupus
Patients with other skeletal, nervous, muscular diseases in the neck and upper limbs
consumption of interfering nutritional supplements
Smoking
related disorders like rotator cuff syndrome and disc inflammation in the cervical spine
Not attending follow-up appointments during various phases of the study Reaction and sensitivity to the prescribed supplement Non-compliance with recommendations and nutritional supplements Intensification of pain and more limitation in joint function Inflammatory diseases such as rheumatoid arthritis, osteoarthritis and lupus Patients with other skeletal, nervous, muscular diseases in the neck and upper limbs consumption of interfering nutritional supplements Smoking related disorders like rotator cuff syndrome and disc inflammation in the cervical spine
عدم مراجعه فرد در مراحل مختلف مطالعه
واکنش و حساسیت به مکمل تجویز شده
عدم تبعیت از توصیه ها و مکمل غذایی ( مصرف کمتر از 80 درصد از مکمل تجویز شده)
تشدید درد و محدودیت بیشتر در عملکرد مفصل
بیماری های التهابی مثل آرتریت روماتوئید، استئوآرتریت و لوپوس
بیماران مبتلا به سایر بیماری های اسکلتی، عصبی، عضلانی در گردن و اندام فوقانی
عدم مراجعه فرد در مراحل مختلف مطالعه
واکنش و حساسیت به مکمل تجویز شده
عدم تبعیت از توصیه ها و مکمل غذایی ( مصرف کمتر از 80 درصد از مکمل تجویز شده)
تشدید درد و محدودیت بیشتر در عملکرد مفصل
بیماری های التهابی مثل آرتریت روماتوئید، استئوآرتریت و لوپوس
بیماران مبتلا به سایر بیماری های اسکلتی، عصبی، عضلانی در گردن و اندام فوقانی
مصرف سایر مکمل های تغذیه¬ای که با کورکومین تداخل دارند
سیگار
بیماری های مشابه مثل سندروم روتاتورکاف، دردهای مربوط به گردن ارجاعی به دست، دردهای ناشی از التهاب دیسک های 4 و 5 ارجاعی به دست
عدم مراجعه فرد در مراحل مختلف مطالعه واکنش و حساسیت به مکمل تجویز شده عدم تبعیت از توصیه ها و مکمل غذایی ( مصرف کمتر از 80 درصد از مکمل تجویز شده) تشدید درد و محدودیت بیشتر در عملکرد مفصل بیماری های التهابی مثل آرتریت روماتوئید، استئوآرتریت و لوپوس بیماران مبتلا به سایر بیماری های اسکلتی، عصبی، عضلانی در گردن و اندام فوقانی مصرف سایر مکمل های تغذیه¬ای که با کورکومین تداخل دارند سیگار بیماری های مشابه مثل سندروم روتاتورکاف، دردهای مربوط به گردن ارجاعی به دست، دردهای ناشی از التهاب دیسک های 4 و 5 ارجاعی به دست
Primary outcomes
#1
Evaluation of pain and disability in patients with frozen shoulder
Evaluation of shoulder function, range of motion, pain, and disability in patients with frozen shoulder.
Evaluation of shoulder function, range of motion, pain, and disability in patients with frozen shoulder.
ارزیابی درد و ناتوانی در بیماران مبتلا به شانه یخ زده
ارزیابی عملکرد شانه، دامنه حرکتی، درد و ناتوانی در بیماران مبتلا به شانه یخ زده
ارزیابی عملکرد شانه، دامنه حرکتی، درد و ناتوانی در بیماران مبتلا به شانه یخ زده
Intervention groups
#1
Intervention group: Intervention group: For 14 days, receiving capsule containing curcumin piperine (containing 500 mg of curcumin extract and 5 mg of piperine) along with manual therapy.
Intervention group: Intervention group: For 14 days, receiving capsule containing curcumin piperine (containing 500 mg of curcumin extract and 5 mg of piperine) along with manual therapy (Three sessions per week).
Intervention group: Intervention group: For 14 days, receiving capsule containing curcumin piperine (containing 500 mg of curcumin extract and 5 mg of piperine) along with manual therapy (Three sessions per week).
گروه مداخله: به مدت 14 روز، دریافت روزانه یک کپسول حاوی کورکومین پیپرین (حاوی 500 میلی گرم عصاره کورکومین و 5 میلی گرم پیپرین) همراه با دست درمانی.
گروه مداخله: به مدت 14 روز، دریافت روزانه یک کپسول حاوی کورکومین پیپرین (حاوی 500 میلی گرم عصاره کورکومین و 5 میلی گرم پیپرین) همراه با دست درمانی (سه جلسه در هفته)..
گروه مداخله: به مدت 14 روز، دریافت روزانه یک کپسول حاوی کورکومین پیپرین (حاوی 500 میلی گرم عصاره کورکومین و 5 میلی گرم پیپرین) همراه با دست درمانی (سه جلسه در هفته)..
#2
Control group: For 14 days, they will only receive manual therapy.
Control group: For 14 days, they will only receive manual therapy (Three sessions per week).
Control group: For 14 days, they will only receive manual therapy (Three sessions per week).
گروه کنترل: به مدت 14 روز، فقط دست درمانی دریافت خواهند کرد.
گروه کنترل: به مدت 14 روز، فقط دست درمانی دریافت خواهند کرد (سه جلسه در هفته).
گروه کنترل: به مدت 14 روز، فقط دست درمانی دریافت خواهند کرد (سه جلسه در هفته).
Recruitment centers
#1
Name of recruitment center - English: Esfahan Province Sports Medicine Board
Name of recruitment center - Persian: هیئت پزشکی ورزشی استان اصفهان
Full name of responsible person - English: Gholamreza Barani
Full name of responsible person - Persian: غلامرضا بارانی
Street address - English: No. 86, Dead End No. 7, Rahim Arbab St., Isfahan
Street address - Persian: اصفهان، خیابان رحیم ارباب، بن بست شماره ۷، پلاک ۸۶
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 127884628
Phone: +98 31 3661 6016
Fax:
Email: Varzeshiisf@gmail.com
Web page address:
Name of recruitment center - English: Esfahan Province Sports Medicine Board Name of recruitment center - Persian: هیئت پزشکی ورزشی استان اصفهان Full name of responsible person - English: Gholamreza Barani Full name of responsible person - Persian: غلامرضا بارانی Street address - English: No. 86, Dead End No. 7, Rahim Arbab St., Isfahan Street address - Persian: اصفهان، خیابان رحیم ارباب، بن بست شماره ۷، پلاک ۸۶ City - English: Isfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 127884628 Phone: +98 31 3661 6016 Fax: Email: Varzeshiisf@gmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Gholamreza Askari
Full name of responsible person - Persian: دکتر غلامرضا عسگری
Street address - English: Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
Street address - Persian: اصفهان، خیابان هزار جریب، معاونت پژوهشی و فناوری دانشگاه علوم پزشکی اصفهان
City - English: isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8174673461
Phone: +98 31 3792 3060
Fax:
Email: askari@mui.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr Gholamreza Askari
Full name of responsible person - Persian: دکتر غلامرضا عسگری
Street address - English: Isfahan University of Medical Sciences, Hezarjarib St., Isfahan
Street address - Persian: اصفهان، خیابان هزار جریب، دانشگاه علوم پزشكي اصفهان
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8174673461
Phone: +98 31 3792 3060
Fax:
Email: askari@mui.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Gholamreza Askari Full name of responsible person - Persian: دکتر غلامرضا عسگری Street address - English: Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib StreetHezarjarib St., Isfahan Street address - Persian: اصفهان، خیابان هزار جریب، معاونت پژوهشی و فناوری دانشگاه علوم پزشکیپزشكي اصفهان City - English: isfahanIsfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8174673461 Phone: +98 31 3792 3060 Fax: Email: askari@mui.ac.ir Web page address:
Protocol summary
Study aim
Evaluation the effect of curcumin-piperine supplementation and manual therapy on metabolic indicators, inflammatory markers, oxidative stress, and electromyography in patients with frozen shoulder
Design
A randomized controlled clinical trial with parallel groups, phase 3, on 60 patients suffering from frozen shoulder
Settings and conduct
Eligible people will be selected with the approval of a orthopedic specialist and will enter the study with full consent. The duration of supplemental is 2 weeks. Blood samples will be taken from all patients to determine and compare the effect of curcumin-piperine and manual therapy or manual therapy on biochemical indicators. All patients are asked to return unused supplements at each visit.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients diagnosed with frozen shoulder by an orthopedic specialist, aged between 20 and 65 years, who are willing to participate in the study. Exclusion criteria include non-compliance with supplement guidelines, adverse reactions, failure to attend study phases, bone and muscular disorders, worsening pain and joint limitations, smoking, and consumption of interfering nutritional supplements. Also excluded are individuals with inflammatory diseases (such as rheumatoid arthritis, osteoarthritis, lupus), skeletal, or muscular conditions in the neck and upper limbs, and related disorders like rotator cuff syndrome and disc inflammation in the cervical spine.
Intervention groups
The subjects of the intervention group, will recieve one curcumin piperine capsule daily (containing 500 mg of curcumin extract and 5 mg of piperine) along with manual therapy (3 sessions per week)for 14 days and the control group will recieve manual therapy (3 sessions per week) for 14 days.
Typographical errors and omission of several important point
Acronym
IRCT registration information
IRCT registration number:IRCT20121216011763N64
Registration date:2024-06-15, 1403/03/26
Registration timing:registered_while_recruiting
Last update:2025-06-14, 1404/03/24
Update count:2
Registration date
2024-06-15, 1403/03/26
Registrant information
Name
Gholamreza Askari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2110
Email address
askari@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of curcumin supplementation along with manual therapy on Metabolic Parameters, Inflammatory Markers, Oxidative Stress, and Electromyography in Frozen Shoulder Patients: A Randomized Clinical Trial
Public title
The effects of curcumin-piperine supplementation along with manual therapy on Frozen Shoulder Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Agreement for participation in the study
Age of 20 to 65 years old
Diagnosis of frozen shoulder syndrome patients by an orthopedic specialist (all grades)
Exclusion criteria:
Not attending follow-up appointments during various phases of the study
Reaction and sensitivity to the prescribed supplement
Non-compliance with recommendations and nutritional supplements
Intensification of pain and more limitation in joint function
Inflammatory diseases such as rheumatoid arthritis, osteoarthritis and lupus
Patients with other skeletal, nervous, muscular diseases in the neck and upper limbs
consumption of interfering nutritional supplements
Smoking
related disorders like rotator cuff syndrome and disc inflammation in the cervical spine
Age
From 20 years old to 65 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done through the official website https://www.sealedenvelope.com/simple-randomiser/v1/list. The participants will be randomly (classified by randomized block method) in one of the two curcumin-piperine supplement groups along with hand therapy and only hand therapy, as the control group. In order to distribute patients into intervention and control groups, first, people will be classified by age and divided using blocks of four. Randomization is done inside each block based on the random chain that will be extracted from the site.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Schools of Pharmacy and Nutrition, Isfahan University of Medical Scien
Street address
Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-03-17, 1402/12/27
Ethics committee reference number
IR.MUI.PHANUT.REC.1402.089
Health conditions studied
1
Description of health condition studied
Frozen Shoulder
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder
Primary outcomes
1
Description
Evaluation of shoulder function, range of motion, pain, and disability in patients with frozen shoulder.
Timepoint
At baseline and after 14 days
Method of measurement
Questionnaire
2
Description
serum level of C-reactive protein (CRP)
Timepoint
At baseline and after 14 days
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kits
3
Description
Total antioxidant capacity
Timepoint
At baseline and after 14 days
Method of measurement
biochemical kit of KiaZist Co.
4
Description
Total oxidant status
Timepoint
At baseline and after 14 days
Method of measurement
biochemical kit of KiaZist Co.
5
Description
Muscle nerve band
Timepoint
At baseline and after 14 days
Method of measurement
Electromyography
6
Description
Malondialdehyde
Timepoint
At baseline and after 14 days
Method of measurement
biochemical kit of KiaZist Co.
7
Description
Serum concentration of glutathione
Timepoint
At baseline and after 14 days
Method of measurement
biochemical kit of KiaZist Co.
8
Description
Superoxide dismutase activity
Timepoint
At baseline and after 14 days
Method of measurement
biochemical kit of KiaZist Co.
9
Description
Serum level of vascular cell adhesion molecule-1
Timepoint
At baseline and after 14 days
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kits
10
Description
erythrocyte sedimentation rate (ESR)
Timepoint
At baseline and after 14 days
Method of measurement
biochemical kit of KiaZist Co.
11
Description
serum level of IL-6
Timepoint
At baseline and after 14 days
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kits
12
Description
serum level of TNF-a
Timepoint
At baseline and after 14 days
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kits
13
Description
serum level of TGF
Timepoint
At baseline and after 14 days
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kits
14
Description
serum level of IL-1β
Timepoint
At baseline and after 14 days
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kits
15
Description
serum level of IL-8
Timepoint
At baseline and after 14 days
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kits
Secondary outcomes
1
Description
The average level of total cholesterol (HDL, LDL, TG) in the intervention and control groups
Timepoint
before and after intervention
Method of measurement
Kiazist biochemical kit
2
Description
The mean level of fasting blood sugar (FBS) among the intervention and control groups
Timepoint
Before and after intervention.
Method of measurement
Kiazist biochemical kit
Intervention groups
1
Description
Intervention group: Intervention group: For 14 days, receiving capsule containing curcumin piperine (containing 500 mg of curcumin extract and 5 mg of piperine) along with manual therapy (Three sessions per week).
Category
Treatment - Drugs
2
Description
Control group: For 14 days, they will only receive manual therapy (Three sessions per week).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthopedic clinic
Full name of responsible person
Dr. Gholamreza Askari
Street address
Shamsabadi
City
isfahan
Province
Isfehan
Postal code
81746 75731
Phone
+98 31 3222 2127
Email
askari@mui.ac.ir
2
Recruitment center
Name of recruitment center
Esfahan Province Sports Medicine Board
Full name of responsible person
Gholamreza Barani
Street address
No. 86, Dead End No. 7, Rahim Arbab St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
127884628
Phone
+98 31 3661 6016
Email
Varzeshiisf@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Gholamreza Askari
Street address
Isfahan University of Medical Sciences, Hezarjarib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
askari@mui.ac.ir
Grant name
Esfahan University of Medical Sciences, Research and Technology Vice-Chancellor
Grant code / Reference number
1402405
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Esfahan University of Medical Sciences, Research and Technology Vice-Chancellor
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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Fax
+98 31 3792 3060
Email
askari@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Fax
+98 31 3792 3060
Email
askari@mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfarayen University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Fax
+98 31 3792 3060
Email
askari@mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available