Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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intervention:3 cap of walnut internal septum daily ,before meal. Control : 3 cap of placebo daily ,before meal.
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Main outcome variables
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Hemoglobin A1C
General information
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Reason for update
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Sample size correction
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Acronym
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IRCT registration information
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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
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Registration date
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2021-02-06, 1399/11/18
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-04-04, 1400/01/15
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Expected recruitment end date
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2021-10-07, 1400/07/15
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Actual recruitment start date
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2021-05-15, 1400/02/25
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Actual recruitment end date
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2021-12-11, 1400/09/20
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Trial completion date
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2021-12-21, 1400/09/30
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Scientific title
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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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Public title
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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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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 25 years old to 70 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-12-22, 1399/10/02
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Ethics committee reference number
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IR.TUMS.TIPS.REC.1399.133
Health conditions studied
1
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Description of health condition studied
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Type 2 diabetes mellitus
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ICD-10 code
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E11.9
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ICD-10 code description
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Type 2 diabetes mellitus without complications
Primary outcomes
1
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Description
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Decreases of hemogllubin A1C (HbA1C)c
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Timepoint
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0 and 12 weeks after initiation of the drug
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Method of measurement
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serum level measurement
Intervention groups
1
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Description
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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).
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Category
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Treatment - Drugs
2
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Description
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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).
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no more information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Publication of clinical report
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When the data will become available and for how long
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After printing the results
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To whom data/document is available
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All people who work in the field of health
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Under which criteria data/document could be used
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There are no special conditions
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From where data/document is obtainable
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Databases in which the article is indexed
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What processes are involved for a request to access data/document
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Search for keywords in databases
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Comments
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