Primary Evaluation of Anti hyperglycemic Effect of internal septum of Juglans regia in patients with diabetes mellitus type II: A Double blind Randomized Clinical Trial
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Protocol summary
Clinical trial with control group, parallel groups, double-blind, randomized, phase 3 on 80 patients.The blocks randomization scheme of permuted method is used for randomization.
Clinical trial with control group, parallel groups, double-blind, randomized, phase 3 on 60 patients.The blocks randomization scheme of permuted method is used for randomization.
Clinical trial with control group, parallel groups, double-blind, randomized, phase 3 on 8060 patients.The blocks randomization scheme of permuted method is used for randomization.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، دو سویه کور ، تصادفی شده، فاز 3 بر روی 80بیمار. برای تصادفی سازی از blocks randomization scheme of permutedروش استفاده میشود.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، دو سویه کور ، تصادفی شده، فاز 3 بر روی 60بیمار. برای تصادفی سازی از blocks randomization scheme of permutedروش استفاده میشود.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، دو سویه کور ، تصادفی شده، فاز 3 بر روی 80بیمار60بیمار. برای تصادفی سازی از blocks randomization scheme of permutedروش استفاده میشود.
Blinding: The patient and the researcher, including resident, the first and second supervisor professors, do not know about the capsules and the randomization will be done by the third supervisor.
Location: Diabetes Clinic of IKHC, Tehran
Procedure: Patients are divided into 2 equal groups of 40 people.One group of drugs and another is placebo are given three times a day before meals.lab tests (check blood levels of hemoglobin A1C, fasting plasma glucose, insulin, hs CRP, C-peptide AST, ALT and ALP, bilirubin and serum creatinine, weight, height and waist and hip circumference and blood pressure, urine analysis (for proteinuria)) Are taken at the beginning and end of the study.To ensure patients' cooperation, medications are provided once every 6 weeks.
Blinding: The patient and the researcher, including resident, the first and second supervisor professors, do not know about the capsules and the randomization will be done by the third supervisor.
Location: Diabetes Clinic of IKHC, Tehran
Procedure: Patients are divided into 2 equal groups of 30 people.One group of drugs and another is placebo are given three times a day before meals.lab tests (check blood levels of hemoglobin A1C, fasting plasma glucose, insulin, hs CRP, C-peptide AST, ALT and ALP, bilirubin and serum creatinine, weight, height and waist and hip circumference and blood pressure, urine analysis (for proteinuria)) Are taken at the beginning and end of the study.To ensure patients' cooperation, medications are provided once every 6 weeks.
Blinding: The patient and the researcher, including resident, the first and second supervisor professors, do not know about the capsules and the randomization will be done by the third supervisor. Location: Diabetes Clinic of IKHC, Tehran Procedure: Patients are divided into 2 equal groups of 4030 people.One group of drugs and another is placebo are given three times a day before meals.lab tests (check blood levels of hemoglobin A1C, fasting plasma glucose, insulin, hs CRP, C-peptide AST, ALT and ALP, bilirubin and serum creatinine, weight, height and waist and hip circumference and blood pressure, urine analysis (for proteinuria)) Are taken at the beginning and end of the study.To ensure patients' cooperation, medications are provided once every 6 weeks.
نحوه ی کورسازی:به صورتی است که بیمار و محقق اعم از دستیار و اساتید راهنمای اول و دوم از کپسول ها اطلاعی نداشته و رندم سازی توسط استاد راهنمای سوم انجام خواهد گرفت .
محل انجام:کلینیک دیابت مجتمع بیمارستانی امام خمینی تهران
نحوه ی انجام:بیماران به دوگروه مساوی 40 نفره تقسیم میشوند،به یک گروه دارو و یک گروه پلاسبو به صورت سه بار در روز قبل از غذا داده میشود.آزمایشات مورد بررسی(چک سطح خونی هموگلوبین A1C، قند خون ناشتا، انسولین،,hs CRP,C- peptide AST، ALT و ALP, بیلیروبین وکراتینین سرم، وزن ، قد و دور کمر و دور باسن و فشار خون ، آنالیز ادرار (جهت بررسی پروتئین اوری)) درابتدا و پایان مطالعه گرفته میشوند. جهت اطمینان از همکاری بیماران،داروها هر6هفته یک بار دراختیار بیماران قرار میگیرد.
نحوه ی کورسازی:به صورتی است که بیمار و محقق اعم از دستیار و اساتید راهنمای اول و دوم از کپسول ها اطلاعی نداشته و رندم سازی توسط استاد راهنمای سوم انجام خواهد گرفت .
محل انجام:کلینیک دیابت مجتمع بیمارستانی امام خمینی تهران
نحوه ی انجام:بیماران به دوگروه مساوی 30 نفره تقسیم میشوند،به یک گروه دارو و یک گروه پلاسبو به صورت سه بار در روز قبل از غذا داده میشود.آزمایشات مورد بررسی(چک سطح خونی هموگلوبین A1C، قند خون ناشتا، انسولین،,hs CRP,C- peptide AST، ALT و ALP, بیلیروبین وکراتینین سرم، وزن ، قد و دور کمر و دور باسن و فشار خون ، آنالیز ادرار (جهت بررسی پروتئین اوری)) درابتدا و پایان مطالعه گرفته میشوند. جهت اطمینان از همکاری بیماران،داروها هر6هفته یک بار دراختیار بیماران قرار میگیرد.
نحوه ی کورسازی:به صورتی است که بیمار و محقق اعم از دستیار و اساتید راهنمای اول و دوم از کپسول ها اطلاعی نداشته و رندم سازی توسط استاد راهنمای سوم انجام خواهد گرفت . محل انجام:کلینیک دیابت مجتمع بیمارستانی امام خمینی تهران نحوه ی انجام:بیماران به دوگروه مساوی 4030 نفره تقسیم میشوند،به یک گروه دارو و یک گروه پلاسبو به صورت سه بار در روز قبل از غذا داده میشود.آزمایشات مورد بررسی(چک سطح خونی هموگلوبین A1C، قند خون ناشتا، انسولین،,hs CRP,C- peptide AST، ALT و ALP, بیلیروبین وکراتینین سرم، وزن ، قد و دور کمر و دور باسن و فشار خون ، آنالیز ادرار (جهت بررسی پروتئین اوری)) درابتدا و پایان مطالعه گرفته میشوند. جهت اطمینان از همکاری بیماران،داروها هر6هفته یک بار دراختیار بیماران قرار میگیرد.
General information
80
60
8060
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60
60
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2021-05-15, 1400/02/25
2021-05-15 00:00:00
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2021-12-11, 1400/09/20
2021-12-11 00:00:00
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2021-12-21, 1400/09/30
2021-12-21 00:00:00
Change in inclusion criteria
Sample size correction
Change in inclusion criteriaSample size correction
تغییر در شرایط ورود به مطالعه
اصلاح حجم نمونه
تغییر در شرایط ورود به مطالعهاصلاح حجم نمونه
Randomization outcome will be done in a block of 4 and through using excel software. This randomization will as follow; at patients arrival to outpatient diabetes clinic, 4 cards (asA, B, C and D) will be introduced and the patient can be chosen only one of them, so then according to the table (four blocks), patient will be divided in group A or B.
Patients will be divided into two groups of 40 people.
Randomization outcome will be done in a block of 4 and through using excel software. This randomization will as follow; at patients arrival to outpatient diabetes clinic, 4 cards (asA, B, C and D) will be introduced and the patient can be chosen only one of them, so then according to the table (four blocks), patient will be divided in group A or B.
Patients will be divided into two groups of 30 people.
Randomization outcome will be done in a block of 4 and through using excel software. This randomization will as follow; at patients arrival to outpatient diabetes clinic, 4 cards (asA, B, C and D) will be introduced and the patient can be chosen only one of them, so then according to the table (four blocks), patient will be divided in group A or B. Patients will be divided into two groups of 4030 people.
نحوه تصادفی سازی:در یک بلوک 4 تایی و با استفاده از نرم افزار excel انجام می شود. این نحوه ی رندوم سازی به شرح زیر است: در بدو ورود بیماران به درمانگاه دیابت ، 4 کارت (A ، B ، C و D) داده می شود و بیمار می تواند فقط یکی از آنها را انتخاب کند ، بنابراین طبق جدول (چهار بلوک) ، بیمار در گروه A یا B تقسیم می شود.بیماران به دو گروه 40 نفره تقسیم می شوند.
نحوه تصادفی سازی:در یک بلوک 4 تایی و با استفاده از نرم افزار excel انجام می شود. این نحوه ی رندوم سازی به شرح زیر است: در بدو ورود بیماران به درمانگاه دیابت ، 4 کارت (A ، B ، C و D) داده می شود و بیمار می تواند فقط یکی از آنها را انتخاب کند ، بنابراین طبق جدول (چهار بلوک) ، بیمار در گروه A یا B تقسیم می شود.بیماران به دو گروه 30 نفره تقسیم می شوند.
نحوه تصادفی سازی:در یک بلوک 4 تایی و با استفاده از نرم افزار excel انجام می شود. این نحوه ی رندوم سازی به شرح زیر است: در بدو ورود بیماران به درمانگاه دیابت ، 4 کارت (A ، B ، C و D) داده می شود و بیمار می تواند فقط یکی از آنها را انتخاب کند ، بنابراین طبق جدول (چهار بلوک) ، بیمار در گروه A یا B تقسیم می شود.بیماران به دو گروه 4030 نفره تقسیم می شوند.
Intervention groups
#1
Control group: in this group, each patient will receive a capsule containing Avicel® as placebo three times a day before meals for 3 months in addition to other anti-diabetic treatments. At the beginning and end of the study (End of the 12th week), 5 cc of blood samples will be taken from patients to assess blood levels of hemoglobin A1C, fasting blood glucose, insulin, hs CRP, C-peptide AST, ALT,ALP, serum bilirubin and creatinine. The patient's weight, height and waist circumference, hip circumference and blood pressure are also measured. A urine sample is taken from the patient at the beginning and end of the study for urine analysis (for assessing proteinuria).
Control group: in this group, each patient will receive a capsule containing pectin as placebo three times a day before meals for 3 months in addition to other anti-diabetic treatments. At the beginning and end of the study (End of the 12th week), 5 cc of blood samples will be taken from patients to assess blood levels of hemoglobin A1C, fasting blood glucose, insulin, hs CRP, C-peptide AST, ALT,ALP, serum bilirubin and creatinine. The patient's weight, height and waist circumference, hip circumference and blood pressure are also measured. A urine sample is taken from the patient at the beginning and end of the study for urine analysis (for assessing proteinuria).
Control group: in this group, each patient will receive a capsule containing Avicel®pectin as placebo three times a day before meals for 3 months in addition to other anti-diabetic treatments. At the beginning and end of the study (End of the 12th week), 5 cc of blood samples will be taken from patients to assess blood levels of hemoglobin A1C, fasting blood glucose, insulin, hs CRP, C-peptide AST, ALT,ALP, serum bilirubin and creatinine. The patient's weight, height and waist circumference, hip circumference and blood pressure are also measured. A urine sample is taken from the patient at the beginning and end of the study for urine analysis (for assessing proteinuria).
گروه کنترل: در این گروه، هر بیمار سه بار در روز کپسول حاوی پودر آویسل به عنوان پلاسبو را قبل از غذا به مدت 3ماه علاوه بر سایر درمان های ضد دیابت دریافت می کنند. در ابتدا و در پایان مطالعه از بیماران 5 سی سی نمونه خون جهت ارزیابی سطح سطح خونی HbA1C، قند خون ناشتا، انسولین،,hs CRP,C- peptide AST، ALT و ALP, بیلیروبین وکراتینین سرم از بیمار گرفته حواهد شد ، همچنین وزن ، قد و دور کمر و دور باسن و فشار خون بیمار اندازه گیری می شود. یک نمونه ی ادرار نیز جهت آنالیز ادرار (جهت بررسی پروتئین اوری) از بیمار در ابتدا و پایان مطالعه گرفته میشود.
گروه کنترل: در این گروه، هر بیمار سه بار در روز کپسول حاوی پودر پکتین به عنوان پلاسبو را قبل از غذا به مدت 3ماه علاوه بر سایر درمان های ضد دیابت دریافت می کنند. در ابتدا و در پایان مطالعه از بیماران 5 سی سی نمونه خون جهت ارزیابی سطح سطح خونی HbA1C، قند خون ناشتا، انسولین،,hs CRP,C- peptide AST، ALT و ALP, بیلیروبین وکراتینین سرم از بیمار گرفته حواهد شد ، همچنین وزن ، قد و دور کمر و دور باسن و فشار خون بیمار اندازه گیری می شود. یک نمونه ی ادرار نیز جهت آنالیز ادرار (جهت بررسی پروتئین اوری) از بیمار در ابتدا و پایان مطالعه گرفته میشود.
گروه کنترل: در این گروه، هر بیمار سه بار در روز کپسول حاوی پودر آویسلپکتین به عنوان پلاسبو را قبل از غذا به مدت 3ماه علاوه بر سایر درمان های ضد دیابت دریافت می کنند. در ابتدا و در پایان مطالعه از بیماران 5 سی سی نمونه خون جهت ارزیابی سطح سطح خونی HbA1C، قند خون ناشتا، انسولین،,hs CRP,C- peptide AST، ALT و ALP, بیلیروبین وکراتینین سرم از بیمار گرفته حواهد شد ، همچنین وزن ، قد و دور کمر و دور باسن و فشار خون بیمار اندازه گیری می شود. یک نمونه ی ادرار نیز جهت آنالیز ادرار (جهت بررسی پروتئین اوری) از بیمار در ابتدا و پایان مطالعه گرفته میشود.
Protocol summary
Study aim
Determining the effectiveness of internal septum of Juglans regia hydro-alcoholic extract on lowering blood glucose.Sub-objectives: Determining the effect of J.regia internal septum extract on weight, waist circumference, waist to hip ratio, hypoglycemia, systolic and diastolic blood pressure, insulin resistance according to QUICKI and HOMA IR index
Design
Clinical trial with control group, parallel groups, double-blind, randomized, phase 3 on 60 patients.The blocks randomization scheme of permuted method is used for randomization.
Settings and conduct
Blinding: The patient and the researcher, including resident, the first and second supervisor professors, do not know about the capsules and the randomization will be done by the third supervisor.
Location: Diabetes Clinic of IKHC, Tehran
Procedure: Patients are divided into 2 equal groups of 30 people.One group of drugs and another is placebo are given three times a day before meals.lab tests (check blood levels of hemoglobin A1C, fasting plasma glucose, insulin, hs CRP, C-peptide AST, ALT and ALP, bilirubin and serum creatinine, weight, height and waist and hip circumference and blood pressure, urine analysis (for proteinuria)) Are taken at the beginning and end of the study.To ensure patients' cooperation, medications are provided once every 6 weeks.
Participants/Inclusion and exclusion criteria
inclusion:Gain conscious satisfaction, 25-70 years, 7≥HbA1C≤9 and FPG = 130-250 mg / dl, receiving metformin and/or other anti-diabetic agents,constant diet ,activity and drug regimen.
Exclusion: walnut allergy, immune deficiency, pregnancy and lactation, cardiovascular disease, receiving medications that alter blood glucose , uncontrolled thyroid disease, acute infection, DKA
Intervention groups
intervention:3 cap of walnut internal septum daily ,before meal. Control : 3 cap of placebo daily ,before meal.
Main outcome variables
Hemoglobin A1C
General information
Reason for update
Sample size correction
Acronym
IRCT registration information
IRCT registration number:IRCT20201229049877N1
Registration date:2021-02-06, 1399/11/18
Registration timing:prospective
Last update:2022-02-14, 1400/11/25
Update count:2
Registration date
2021-02-06, 1399/11/18
Registrant information
Name
Fatemeh Afra
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4441 4751
Email address
f-afra@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-10-07, 1400/07/15
Actual recruitment start date
2021-05-15, 1400/02/25
Actual recruitment end date
2021-12-11, 1400/09/20
Trial completion date
2021-12-21, 1400/09/30
Scientific title
Primary Evaluation of Anti hyperglycemic Effect of internal septum of Juglans regia in patients with diabetes mellitus type II: A Double blind Randomized Clinical Trial
Public title
Evaluation of Anti hyperglycemic Effect of internal septum of Juglans regia in patients with diabetes mellitus type II: A Double blind Randomized Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Obtain consent from patients
Age between 25 and 70 year old
HbA1C≥7% and less than 9% and FPG = 130-250 mg / dl
Take metformin and/or other anti-diabetic agents (in maximum and constant dose for three months) or metformin alone (in maximum and constant dose for three months)
Constant diet and physical activity during the study (according to a questionnaire translated and validated into Persian)
The patient's anti-diabetic medication regimen remained constant during the study
No allergies to walnuts
Exclusion criteria:
History of walnut allergy
Immune system defects
Pregnancy and lactation
Cardiovascular disease (coronary artery ischemia, EF <45%)
Take medications that change blood glucose levels (corticosteroids, tacrolimus, anti-AIDS drugs, antipsychotic drugs)
Uncontrolled thyroid disease
Acute infection
History of diabetic ketoacidosis
eGFR<60 ml/min
Acute hepatitis (increase in ALT and AST to more than 10 to 20 times normal)
cirrhosis
Proliferative retinopathy
Severe weight loss (at least 10% over 6 months)
Consumption of any other medicine and herbal products, including walnuts
Age
From 25 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization outcome will be done in a block of 4 and through using excel software. This randomization will as follow; at patients arrival to outpatient diabetes clinic, 4 cards (asA, B, C and D) will be introduced and the patient can be chosen only one of them, so then according to the table (four blocks), patient will be divided in group A or B.
Patients will be divided into two groups of 30 people.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study,both of patients and researcher are blinded.Placebo is prepared same as the drug capsule.Drug and placebo are coded into A and B by the third supervisor and randomized by block randomization method.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of the Research Institute of Pharmaceutical Sciences, Tehran University of
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1476947143
Approval date
2020-12-22, 1399/10/02
Ethics committee reference number
IR.TUMS.TIPS.REC.1399.133
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11.9
ICD-10 code description
Type 2 diabetes mellitus without complications
Primary outcomes
1
Description
Decreases of hemogllubin A1C (HbA1C)c
Timepoint
0 and 12 weeks after initiation of the drug
Method of measurement
serum level measurement
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in this group, each patient will receive a capsule containing lyophilized powder of hydroalcoholic extract of internal septum of walnut (J. regia) three times a day before meals for 3 months in addition to other anti-diabetic treatments. At the beginning and end of the study (End of the 12th week), 5 cc of blood samples will be taken from patients to assess blood levels of hemoglobin A1C, fasting blood glucose, insulin, hs CRP, C-peptide AST, ALT,ALP, serum bilirubin and creatinine. The patient's weight, height and waist circumference, hip circumference and blood pressure are also measured. A urine sample is taken from the patient at the beginning and end of the study for urine analysis (for assessing proteinuria).
Category
Treatment - Drugs
2
Description
Control group: in this group, each patient will receive a capsule containing pectin as placebo three times a day before meals for 3 months in addition to other anti-diabetic treatments. At the beginning and end of the study (End of the 12th week), 5 cc of blood samples will be taken from patients to assess blood levels of hemoglobin A1C, fasting blood glucose, insulin, hs CRP, C-peptide AST, ALT,ALP, serum bilirubin and creatinine. The patient's weight, height and waist circumference, hip circumference and blood pressure are also measured. A urine sample is taken from the patient at the beginning and end of the study for urine analysis (for assessing proteinuria).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital complex ,Tehran
Full name of responsible person
Fatemeh Afra
Street address
Dr .Gharib Ave
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1692
Fax
+98 21 6119 2353
Email
Imamhospital@tums.ac.ir
Web page address
http://ikhc.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soha Namazi
Street address
pharmaceutical care department,Valiasr hospital,Imam Khomeini Hospital Complex, Tohid Squre
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1692
Fax
+98 21 6119 2353
Email
namazisoha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Soha Namazi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmaceutical care department,Valiasr hospital,Imam Khomeini Hospital Complex, Tohid Squre
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1692
Email
namazisoha@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soha Namazi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmaceutical care department,Valiasr hospital,Imam Khomeini Hospital Complex, Tohid Squre
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1692
Email
namazisoha@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Afra
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No 6,shahid marvi Alley, sardarjangal Ave
City
Tehran
Province
Tehran
Postal code
1476947143
Phone
+98 21 4441 4751
Email
fatemehafraus@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
Publication of clinical report
When the data will become available and for how long
After printing the results
To whom data/document is available
All people who work in the field of health
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
Databases in which the article is indexed
What processes are involved for a request to access data/document