Evaluation of the effects of capsules containing probiotics on metabolic parameters, oxidative stress and clinical symptoms of age-related macular degeneration
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Protocol summary
This study will be designed as a clinical trial.Double-blind control-placebo is performed on 60 patients with ARMD in the range of 50-85 years old. First, patients are identified based on biochemical findings and a fundoscopic finding with ARMD history.Then they are treated with one of the treatment groups or placebo
This study will be designed as a clinical trial.Double-blind control-placebo is performed on 70 patients with ARMD in the range of 50-85 years old. First, patients are identified based on biochemical findings and a fundoscopic finding with ARMD history.Then they are treated with one of the treatment groups or placebo
This study will be designed as a clinical trial.Double-blind control-placebo is performed on 6070 patients with ARMD in the range of 50-85 years old. First, patients are identified based on biochemical findings and a fundoscopic finding with ARMD history.Then they are treated with one of the treatment groups or placebo
این مطالعه بصورت یک کارآزمایی بالینی طراحی خواهد شد. دو سوکور کنترل - پلاسبو بر روی 60 بیمار مبتلا به ARMDدر محدوده سنی 50-85 سال انجام می گیرد.ابتدا بیماران بر اساس یافته های بیوشیمیایی و فوندوسکوپی با سابقه ARMD، شناسایی می شود. سپس تحت درمان یکی از گروههای درمان و یا پلاسبو قرار می گیرند.
این مطالعه بصورت یک کارآزمایی بالینی طراحی خواهد شد. دو سوکور کنترل - پلاسبو بر روی 70 بیمار مبتلا به ARMDدر محدوده سنی 50-85 سال انجام می گیرد.ابتدا بیماران بر اساس یافته های بیوشیمیایی و فوندوسکوپی با سابقه ARMD، شناسایی می شود. سپس تحت درمان یکی از گروههای درمان و یا پلاسبو قرار می گیرند.
این مطالعه بصورت یک کارآزمایی بالینی طراحی خواهد شد. دو سوکور کنترل - پلاسبو بر روی 6070 بیمار مبتلا به ARMDدر محدوده سنی 50-85 سال انجام می گیرد.ابتدا بیماران بر اساس یافته های بیوشیمیایی و فوندوسکوپی با سابقه ARMD، شناسایی می شود. سپس تحت درمان یکی از گروههای درمان و یا پلاسبو قرار می گیرند.
This clinical trial is performed on 60 individuals with age-related macular degeneration which referred to Kashan Matini Hospital.Individuals based on random Blocks (one per group) will be divided to probotic or placebo capsule,one per day for 2 months. Individuals checked by the phone monthly and at the beginning and end of the study they will have a visit and blood tests and clinical examinations will be done for them. All drug are presented in the same package and the physician , patients, researcher and statistical analyst are blind .After analyzing data, codes will be decoded.
This clinical trial is performed on 70 individuals with age-related macular degeneration which referred to Kashan Matini Hospital.Individuals based on random Blocks (one per group) will be divided to probotic or placebo capsule,one per day for 2 months. Individuals checked by the phone monthly and at the beginning and end of the study they will have a visit and blood tests and clinical examinations will be done for them. All drug are presented in the same package and the physician , patients, researcher and statistical analyst are blind .After analyzing data, codes will be decoded.
This clinical trial is performed on 6070 individuals with age-related macular degeneration which referred to Kashan Matini Hospital.Individuals based on random Blocks (one per group) will be divided to probotic or placebo capsule,one per day for 2 months. Individuals checked by the phone monthly and at the beginning and end of the study they will have a visit and blood tests and clinical examinations will be done for them. All drug are presented in the same package and the physician , patients, researcher and statistical analyst are blind .After analyzing data, codes will be decoded.
این کارآزمایی بالینی بر روی 60 فرد مبتلا به دژنراسیون ماکولای مرتبط با سن مراجعه کننده به بیمارستان متینی کاشان اجرا می شود. افراد به روش تصادفی بلوکی ( یک نفر در هر گروه) به 2 گروه درمان کپسول پروبیوتیک یا پلاسبو روزانه 1عدد به صورت خوراکی برای 2ماه تقسیم خواهند شد. افراد ماهانه به صورت تلفنی پیگیری می شوند و در ابتدا و انتهای مطالعه ویزیت حضوری شده و آزمایشات و معاینات برای آنها انجام می شود. داروها در بسته بندی مشابه عرضه می شود و پزشک و بیمار، محقق، و آنالیز کننده آماری از نوع آن بی خبرند و پس از پایان آنالیز داده ها کدها رمز گشایی می شوند.
این کارآزمایی بالینی بر روی 70 فرد مبتلا به دژنراسیون ماکولای مرتبط با سن مراجعه کننده به بیمارستان متینی کاشان اجرا می شود. افراد به روش تصادفی بلوکی ( یک نفر در هر گروه) به 2 گروه درمان کپسول پروبیوتیک یا پلاسبو روزانه 1عدد به صورت خوراکی برای 2ماه تقسیم خواهند شد. افراد ماهانه به صورت تلفنی پیگیری می شوند و در ابتدا و انتهای مطالعه ویزیت حضوری شده و آزمایشات و معاینات برای آنها انجام می شود. داروها در بسته بندی مشابه عرضه می شود و پزشک و بیمار، محقق، و آنالیز کننده آماری از نوع آن بی خبرند و پس از پایان آنالیز داده ها کدها رمز گشایی می شوند.
این کارآزمایی بالینی بر روی 6070 فرد مبتلا به دژنراسیون ماکولای مرتبط با سن مراجعه کننده به بیمارستان متینی کاشان اجرا می شود. افراد به روش تصادفی بلوکی ( یک نفر در هر گروه) به 2 گروه درمان کپسول پروبیوتیک یا پلاسبو روزانه 1عدد به صورت خوراکی برای 2ماه تقسیم خواهند شد. افراد ماهانه به صورت تلفنی پیگیری می شوند و در ابتدا و انتهای مطالعه ویزیت حضوری شده و آزمایشات و معاینات برای آنها انجام می شود. داروها در بسته بندی مشابه عرضه می شود و پزشک و بیمار، محقق، و آنالیز کننده آماری از نوع آن بی خبرند و پس از پایان آنالیز داده ها کدها رمز گشایی می شوند.
General information
60
70
6070
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70
70
No
No
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2018-05-20, 1397/02/30
2018-05-20 00:00:00
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2018-11-21, 1397/08/30
2018-11-21 00:00:00
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2019-01-20, 1397/10/30
2019-01-20 00:00:00
empty
Due to changes occur during the trial
Due to changes occur during the trial
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به علت تغییرات ایجاد شده در زمان انجام مطالعه
به علت تغییرات ایجاد شده در زمان انجام مطالعه
Health conditions studied
#1
age-related macular degeneration
Age-related macular degeneration
ageAge-related macular degeneration
Primary outcomes
#1
Visual Acuity
High sensitive-Critical Reactive Protein
Visual AcuityHigh sensitive-Critical Reactive Protein
حدت بينايي
پروتئین واکنشی C باحساسیت بالا
حدت بيناييپروتئین واکنشی C باحساسیت بالا
Visual Acuity check with snellen chart
ELISA
Visual Acuity check with snellen chartELISA
حدت بینایی بوسیله چارت اسنلن اندازه گیری می شود
الایزا
حدت بینایی بوسیله چارت اسنلن اندازه گیری می شودالایزا
#2
Metabolic Indicators( fasting blood sugar,Triglyceride and low and High density lipoprotein, high sensitive-Critical Reactive Protein)
empty
Metabolic Indicators( fasting blood sugar,Triglyceride and low and High density lipoprotein, high sensitive-Critical Reactive Protein)
شاخص های متابولیکی(قند خون ناشتا، تری گلیسیرید، لیپوپروتئین با وزن مولکولی پایین، لیپوپروتئین با وزن مولکولی بالا، پروتئین واکنشی C باحساسیت بالا)
empty
شاخص های متابولیکی(قند خون ناشتا، تری گلیسیرید، لیپوپروتئین با وزن مولکولی پایین، لیپوپروتئین با وزن مولکولی بالا، پروتئین واکنشی C باحساسیت بالا)
At the beginning of the study and 2 months after the start of the study
empty
At the beginning of the study and 2 months after the start of the study
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
empty
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
laboratory kit
empty
laboratory kit
کیت آزمایشگاهی
empty
کیت آزمایشگاهی
#3
Macular thickness
empty
Macular thickness
ضخامت ماکولا
empty
ضخامت ماکولا
At the beginning of the study and2 months after the start of the study
empty
At the beginning of the study and2 months after the start of the study
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
empty
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
Central Macular Thickness Evaluate with OCT Instrument
empty
Central Macular Thickness Evaluate with OCT Instrument
اندازه گیری ضخامت ماکولا بر حسب میکرومتر و با دستگاه OCT صورت می گیرد
empty
اندازه گیری ضخامت ماکولا بر حسب میکرومتر و با دستگاه OCT صورت می گیرد
#4
Stress Oxidation Indicators (Total Plasma Antioxidant, Total Glutathione, and Malondialdehyde Plasma)
empty
Stress Oxidation Indicators (Total Plasma Antioxidant, Total Glutathione, and Malondialdehyde Plasma)
شاخص های استرس اکسیداتیو(توتال آنتی اکسیدانت پلاسمایی، گلوتاتیون توتال و مالون دی آلدئید پلاسما)
empty
شاخص های استرس اکسیداتیو(توتال آنتی اکسیدانت پلاسمایی، گلوتاتیون توتال و مالون دی آلدئید پلاسما)
At the beginning of the study and2 months after the start of the study
empty
At the beginning of the study and2 months after the start of the study
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
empty
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
Blood test
empty
Blood test
آزمایش خون
empty
آزمایش خون
Secondary outcomes
#1
empty
Visual Acuity
Visual Acuity
empty
حدت بينايي
حدت بينايي
empty
At the beginning of the study and 2 months after the start of the study
At the beginning of the study and 2 months after the start of the study
empty
ابتدای مطالعه و 2ماه پس از شروع مطالعه
ابتدای مطالعه و 2ماه پس از شروع مطالعه
empty
Visual Acuity check with Snellen chart
Visual Acuity check with Snellen chart
empty
حدت بینایی بوسیله چارت اسنلن اندازه گیری می شود
حدت بینایی بوسیله چارت اسنلن اندازه گیری می شود
#2
empty
Macular thickness
Macular thickness
empty
ضخامت ماکولا
ضخامت ماکولا
empty
At the beginning of the study and 2 months after the start of the study
At the beginning of the study and 2 months after the start of the study
empty
ابتدای مطالعه و 2ماه پس از شروع مطالعه
ابتدای مطالعه و 2ماه پس از شروع مطالعه
empty
Central Macular Thickness Evaluate with OCT Instrument
Central Macular Thickness Evaluate with OCT Instrument
empty
اندازه گیری ضخامت ماکولا بر حسب میکرومتر و با دستگاه OCT صورت می گیرد
اندازه گیری ضخامت ماکولا بر حسب میکرومتر و با دستگاه OCT صورت می گیرد
#3
empty
Fasting plasma glucose
Fasting plasma glucose
empty
قند خون ناشتا
قند خون ناشتا
empty
At the beginning of the study and 2 months after the start of the study
At the beginning of the study and 2 months after the start of the study
empty
ابتدای مطالعه و 2ماه پس از شروع مطالعه
ابتدای مطالعه و 2ماه پس از شروع مطالعه
empty
Enzymatic Kits
Enzymatic Kits
empty
کیت آنزیمی
کیت آنزیمی
#4
empty
Triglycerides
Triglycerides
empty
تری گلیسیرید
تری گلیسیرید
empty
At the beginning of the study and 2 months after the start of the study
At the beginning of the study and 2 months after the start of the study
empty
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
empty
Enzymatic Kits
Enzymatic Kits
empty
کیت آنزیمی
کیت آنزیمی
#5
empty
Low density lipoprotein-cholesterol
Low density lipoprotein-cholesterol
empty
لیپوپروتئین با وزن مولکولی پایین-کلسترول
لیپوپروتئین با وزن مولکولی پایین-کلسترول
empty
At the beginning of the study and 2 months after the start of the study
At the beginning of the study and 2 months after the start of the study
empty
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
empty
Enzymatic Kits
Enzymatic Kits
empty
کیت آنزیمی
کیت آنزیمی
#6
empty
High density lipoprotein-cholesterol
High density lipoprotein-cholesterol
empty
لیپوپروتئین با وزن مولکولی بالا-کلسترول
لیپوپروتئین با وزن مولکولی بالا-کلسترول
empty
At the beginning of the study and 2 months after the start of the study
At the beginning of the study and 2 months after the start of the study
empty
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
empty
Enzymatic Kits
Enzymatic Kits
empty
کیت آنزیمی
کیت آنزیمی
#7
empty
Total cholesterol
Total cholesterol
empty
کلسترول تام
کلسترول تام
empty
At the beginning of the study and 2 months after the start of the study
At the beginning of the study and 2 months after the start of the study
empty
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
empty
Enzymatic Kits
Enzymatic Kits
empty
کیت آنزیمی
کیت آنزیمی
#8
empty
Very low density lipoprotein-cholesterol
Very low density lipoprotein-cholesterol
empty
لیپوپروتئین با چگالی بسیار پایین-کلسترول
لیپوپروتئین با چگالی بسیار پایین-کلسترول
empty
At the beginning of the study and 2 months after the start of the study
At the beginning of the study and 2 months after the start of the study
empty
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
empty
Standard formula
Standard formula
empty
فرمول استاندارد
فرمول استاندارد
#9
empty
Nitric oxide
Nitric oxide
empty
نیتریک اکسید
نیتریک اکسید
empty
At the beginning of the study and 2 months after the start of the study
At the beginning of the study and 2 months after the start of the study
empty
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
empty
Photospectrometry
Photospectrometry
empty
فتواسپکترومتری
فتواسپکترومتری
#10
empty
Malondialdehyde
Malondialdehyde
empty
مالون دی آلدهید
مالون دی آلدهید
empty
At the beginning of the study and 2 months after the start of the study
At the beginning of the study and 2 months after the start of the study
empty
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
empty
Photospectrometry
Photospectrometry
empty
فتواسپکترومتری
فتواسپکترومتری
#11
empty
Glutathion
Glutathion
empty
گلوتاتیون
گلوتاتیون
empty
At the beginning of the study and 2 months after the start of the study
At the beginning of the study and 2 months after the start of the study
empty
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
empty
Photospectrometry
Photospectrometry
empty
فتواسپکترومتری
فتواسپکترومتری
#12
empty
Total Anti Oxidant
Total Anti Oxidant
empty
ظرفیت تام آنتی اکسیدانی
ظرفیت تام آنتی اکسیدانی
empty
At the beginning of the study and 2 months after the start of the study
At the beginning of the study and 2 months after the start of the study
empty
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
empty
Photospectrometry
Photospectrometry
empty
فتواسپکترومتری
فتواسپکترومتری
#13
empty
Insulin
Insulin
empty
انسولین
انسولین
empty
At the beginning of the study and 2 months after the start of the study
At the beginning of the study and 2 months after the start of the study
empty
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
empty
ELISA
ELISA
empty
الایزا
الایزا
#14
empty
QUICKI
QUICKI
empty
شاخص حساسیت به انسولین
شاخص حساسیت به انسولین
empty
At the beginning of the study and 2 months after the start of the study
At the beginning of the study and 2 months after the start of the study
empty
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
empty
Standard formula
Standard formula
empty
فرمول استاندارد
فرمول استاندارد
#15
empty
HOMA-IR
HOMA-IR
empty
شاخص مقاومت یه انسولین
شاخص مقاومت یه انسولین
empty
At the beginning of the study and 2 months after the start of the study
At the beginning of the study and 2 months after the start of the study
empty
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
ابتدای مطالعه و 2 ماه پس از شروع مطالعه
empty
Standard formula
Standard formula
empty
فرمول استاندارد
فرمول استاندارد
Intervention groups
#1
گروه مداخله:کپسول پروبیوتیک 500میلیگرم ساخت شرکت تک ژن، روزانه 2 عدد به صورت خوراکی برای مدت 2 ماه
گروه مداخله:کپسول پروبیوتیک 500میلیگرم ساخت شرکت تک ژن، روزانه 1 عدد به صورت خوراکی برای مدت 2 ماه
گروه مداخله:کپسول پروبیوتیک 500میلیگرم ساخت شرکت تک ژن، روزانه 21 عدد به صورت خوراکی برای مدت 2 ماه
#2
Control group: placebo capsule500 MG, produced in tak gene company, ,One number per day for 2 months orally.
Control group: placebo capsule500 MG, produced in Tak gene company, ,One number per day for 2 months orally.
Control group: placebo capsule500 MG, produced in takTak gene company, ,One number per day for 2 months orally.
Recruitment centers
#1
Name of recruitment center - English: Matini Hospital
Name of recruitment center - Persian: بیمارستان متینی کاشان
Full name of responsible person - English: Hasan Farajipoor
Full name of responsible person - Persian: حسن فرجی پور
Street address - English: Iran, Kashan, Amir Kabir Street, Matini Hospital
Street address - Persian: ایران ، کاشان ، خیابان امیرکبیر ، بیمارستان متینی کاشان
City - English: kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5534 4271
Fax:
Email: farajipoor_h@kaums.ac.ir
Web page address:
Name of recruitment center - English: Matini Hospital
Name of recruitment center - Persian: بیمارستان متینی کاشان
Full name of responsible person - English: Hasan Farajipoor
Full name of responsible person - Persian: حسن فرجی پور
Street address - English: Matini Hospital, Amir Kabir Street, Kashan, Iran
Street address - Persian: ایران ، کاشان ، خیابان امیرکبیر ، بیمارستان متینی کاشان
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5534 4271
Fax:
Email: farajipoor_h@kaums.ac.ir
Web page address:
Name of recruitment center - English: Matini Hospital Name of recruitment center - Persian: بیمارستان متینی کاشان Full name of responsible person - English: Hasan Farajipoor Full name of responsible person - Persian: حسن فرجی پور Street address - English: Iran, KashanMatini Hospital, Amir Kabir Street, Matini HospitalKashan, Iran Street address - Persian: ایران ، کاشان ، خیابان امیرکبیر ، بیمارستان متینی کاشان City - English: kashanKashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 81151-87159 Phone: +98 31 5534 4271 Fax: Email: farajipoor_h@kaums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hamid Reza Banafshe
Full name of responsible person - Persian: حمید رضا بنفشه
Street address - English: Kashan University of Medical Sciences, Kashan, Iran
Street address - Persian: ایران ، کاشان ، بلوار قطب راوندی ، دانشگاه علوم پزشکی کاشان
City - English: kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5554 2999
Fax:
Email: banafsheh_h@kaums.ac.ir
Web page address: http://kaums.ac.ir
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hamid Reza Banafshe
Full name of responsible person - Persian: حمید رضا بنفشه
Street address - English: Kashan University of Medical Sciences, Qotbe Ravandi Boulevard, Kashan
Street address - Persian: ایران ، کاشان ، بلوار قطب راوندی ، دانشگاه علوم پزشکی کاشان
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5554 2999
Fax:
Email: banafsheh_h@kaums.ac.ir
Web page address: http://kaums.ac.ir
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Hamid Reza Banafshe Full name of responsible person - Persian: حمید رضا بنفشه Street address - English: Kashan University of Medical Sciences, KashanQotbe Ravandi Boulevard, IranKashan Street address - Persian: ایران ، کاشان ، بلوار قطب راوندی ، دانشگاه علوم پزشکی کاشان City - English: kashanKashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 81151-87159 Phone: +98 31 5554 2999 Fax: Email: banafsheh_h@kaums.ac.ir Web page address: http://kaums.ac.ir
Protocol summary
Study aim
Determination of the effect of probiotic capsule on metabolic parameters, oxidative stress and clinical signs of age-related macular degeneration (AMD), 1397 in Kashan
Design
This study will be designed as a clinical trial.Double-blind control-placebo is performed on 70 patients with ARMD in the range of 50-85 years old. First, patients are identified based on biochemical findings and a fundoscopic finding with ARMD history.Then they are treated with one of the treatment groups or placebo
Settings and conduct
This clinical trial is performed on 70 individuals with age-related macular degeneration which referred to Kashan Matini Hospital.Individuals based on random Blocks (one per group) will be divided to probotic or placebo capsule,one per day for 2 months. Individuals checked by the phone monthly and at the beginning and end of the study they will have a visit and blood tests and clinical examinations will be done for them. All drug are presented in the same package and the physician , patients, researcher and statistical analyst are blind .After analyzing data, codes will be decoded.
Participants/Inclusion and exclusion criteria
Entrance criteria: aged 50 to 85 years, diminished vision solely due to AMD
Exit criteria: corneal opacity, diabetes, history of retinal vascular disorders, history of retina tear, history of penetrating trauma
Intervention groups
Intervention group: probiotic capsule 500 mg, produced in tak gene company, ,One number per day for 2
months orally. Control group: placebo capsule 500 Mg, produced in tak gene company, ,One number per day for 2 months orally.
Evaluation of the effects of capsules containing probiotics on metabolic parameters, oxidative stress and clinical symptoms of age-related macular degeneration
Public title
The effect of probiotic capsule on patients with macular degeneration associated with age
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Reduced vision simply because of AMD
Exclusion criteria:
Corneal opacity
Diabetes
History of retinal vascular disorders
History of retina tear
History of penetrating trauma
Age
From 50 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Random Blocks (one per group): Patients will be divided into two groups, probiotic (case) and placebo (control ). The division of selected subjects will be done randomly in blocks of study using quadrilateral blocks. The division of selected subjects will be done in randomized blocks using six rows of four blocks (ABAB-BABA-ABBA-BAAB-AABB-BBAA). probiotic capsule (A) and placebo group (B). In this way, different scenarios are written on six cards and will be thrown into a bag and 60 cards will be written out of the bag for 15 times, and the order will be written in a sheet.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs and placebo are in the same packaging at the Barij Essence pharmaceutical company . Only the code is written on the packages. Patients and physician do not know the type of drug and after analyzing the data, packet codes are decoded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kashan university of medical sciences
Street address
Kashan University of Medical Sciences,Qotbe Ravandi Boulevard, Kashan
City
kashan
Province
Isfehan
Postal code
8115187159
Approval date
2017-12-11, 1396/09/20
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1396.16
Health conditions studied
1
Description of health condition studied
Age-related macular degeneration
ICD-10 code
H35.3
ICD-10 code description
Degeneration of macula and posterior pole
Primary outcomes
1
Description
High sensitive-Critical Reactive Protein
Timepoint
At the beginning of the study and2 months after the start of the study
Method of measurement
ELISA
Secondary outcomes
1
Description
Visual Acuity
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Visual Acuity check with Snellen chart
2
Description
Macular thickness
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Central Macular Thickness Evaluate with OCT Instrument
3
Description
Fasting plasma glucose
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Enzymatic Kits
4
Description
Triglycerides
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Enzymatic Kits
5
Description
Low density lipoprotein-cholesterol
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Enzymatic Kits
6
Description
High density lipoprotein-cholesterol
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Enzymatic Kits
7
Description
Total cholesterol
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Enzymatic Kits
8
Description
Very low density lipoprotein-cholesterol
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Standard formula
9
Description
Nitric oxide
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Photospectrometry
10
Description
Malondialdehyde
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Photospectrometry
11
Description
Glutathion
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Photospectrometry
12
Description
Total Anti Oxidant
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Photospectrometry
13
Description
Insulin
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
ELISA
14
Description
QUICKI
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Standard formula
15
Description
HOMA-IR
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Standard formula
Intervention groups
1
Description
Intervention group: probiotic capsule 500 MG,produced in tak gene company,One number per day for 2 months orally.
Category
Treatment - Drugs
2
Description
Control group: placebo capsule500 MG, produced in Tak gene company, ,One number per day for 2 months orally.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Matini Hospital
Full name of responsible person
Hasan Farajipoor
Street address
Matini Hospital, Amir Kabir Street, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5534 4271
Email
farajipoor_h@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Street address
Kashan University of Medical Sciences, Qotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 2999
Email
banafsheh_h@kaums.ac.ir
Web page address
http://kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Hasan Farajipoor
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Kashan University of Medical Sciences, Qotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 0021
Email
farajipoor_h@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
mMohsen Taghizadeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Kashan University of Medical Sciences, Qotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8719675537
Phone
+98 31 5533 3213
Email
taghizadeh_m@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohsen Taghizadeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Kashan University of Medical Sciences,Qotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
871967537
Phone
+98 31 5533 3213
Email
taghizadeh_m@kaums.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