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IRCT20150711023153N6 IRCT 2025-11-04 Yasouj University of Medical Sciences The effect of combining extracts of garlic, ginger, olive oil, and lemon juice in the treatment of diabetes Investigating the effect of the combination of garlic, ginger, olive oil, and lemon juice extracts on blood pressure, blood sugar, and lipid profile in diabetic patients: A clinical trial 2026-04-21 anticipated 60 Complete https://irct.ir/trial/86557 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: Capsule (capsule containing a combination of garlic and ginger, olive oil and lemon juice) produced by the Faculty of Pharmacy, Shiraz University of Medical Sciences, Randomization description: Block randomization will be implemented using Randomization.com, so that there are 2 blocks in each group (each block contains 15 patients), which are divided based on body mass index (BMI) and duration of diabetes. To create a randomization list on the "Randomization.com" website, follow the steps below, and click on Is randomization.com "validated?". Then clicked, on the new page, click on the "Randomization Plan generator" option, on the new page: enter the type of intervention (I, P) in the box "(Treatment labels: (enter as many as necessary)), the number of blocks (4) In the "Number of subjects per block" box, enter the number of subjects per block (15) in the "Number of blocks" box, and in the "Initial subject ID number" box, enter a random number at the beginning, and at the end Enter the "generate plan" box. We do this four times and create four randomization lists, Blinding description: The placebo is the same capsule without the active ingredients, which will be completely similar in shape, size, color and texture to the pills containing the main ingredient in order to control the psychological effects of taking the drug. And with similar packaging that is encoded with a special code such as A and B at the time of packaging. This code is kept in a special envelope in the nutrition group and no one will know the contents of the envelope until the end of the study. And the intervention and placebo will be distributed to the participants by a third party (nurse or department expert) during the study. N/A Type 2 diabetes. Intervention 1: Intervention group: Patients receiving capsules (capsules containing a combination of garlic and ginger, olive oil, and lemon juice) produced by the Faculty of Health and Nutrition, Yasuj University of Medical Sciences, will be given one capsule daily for 8 weeks. Intervention 2: Control group: Patients receiving cellulose capsules (containing cellulose compounds) produced by the Faculty of Health and Nutrition, Yasuj University of Medical Sciences, will be given one capsule daily for 8 weeks. Yes - There is a plan to make this available What will be shared: Data on primary variables will be shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: The data will only be available to researchers working in academic and scientific institutions Conditions: Data will be allowed to be reanalyzed for use in secondary studies such as meta-analyses Where to obtain: Seyed Bahman Panahande, Yasuj University of Medical Sciences, Yasuj, Iran. Email:panahande.b@gmail.com P.O. Box 7591741417, Tel:+98- 074-33346078, Fax:+98- 074-33346079, How to obtain: After receiving approval from Yasuj University of Medical Sciences (one week to one month), thedata will be sent to the applicant Comments:
public Fatemeh Marzbani
Imam Hossein Square 15, Golestan, Faculty of Health and Nutrition
Yasuj Iran (Islamic Republic of) 7591875114 +98 74 3322 5519 famarz1398@gmail.com Yasouj University of Medical Sciences scientific Seyed Bahman Panahande
Imam Hossein Square - Golestan 15, Faculty of Health and Nutrition
Yasuj Iran (Islamic Republic of) 7591875114 +98 74 3322 5519 panahande.b@yums.ac.ir Yasouj University of Medical Sciences Iran (Islamic Republic of) Type 2 diabetic patients Age over 18 years 18 years 65 years Both Suffering from cardiovascular, liver, kidney disease and other complications of diabetes such as diabetic foot ulcers Pregnancy and breastfeeding Diabetic patients over 65 years old Diabetic patients using insulin or acarbose E11 Type 2 diabetes mellitus Other Placebo Intervention group: Patients receiving capsules (capsules containing a combination of garlic and ginger, olive oil, and lemon juice) produced by the Faculty of Health and Nutrition, Yasuj University of Medical Sciences, will be given one capsule daily for 8 weeks. Control group: Patients receiving cellulose capsules (containing cellulose compounds) produced by the Faculty of Health and Nutrition, Yasuj University of Medical Sciences, will be given one capsule daily for 8 weeks. HbA1C. Timepoint: At the beginning and end of the intervention period. Method of measurement: Laboratory methods - Elisa Kit. Low density lipoprotein. Timepoint: At the beginning and end of the intervention period. Method of measurement: Laboratory methods - Elisa Kit. High density lipoprotein. Timepoint: At the beginning and end of the intervention period. Method of measurement: Laboratory methods - Elisa Kit. Triglyceride. Timepoint: At the beginning and end of the intervention period. Method of measurement: Laboratory methods - Elisa Kit. Total cholesterol. Timepoint: At the beginning and end of the intervention period. Method of measurement: Laboratory methods - Elisa Kit. Weight. Timepoint: Before and after the period of intervention. Method of measurement: Body Composition. Systolic and diastolic blood pressure. Timepoint: Before and after the period of intervention. Method of measurement: Blood pressure monitor. Yasouj University of Medical Sciences Approved 2025-06-18 Ethics Committee of Yasouj University of Medical Sciences Yasuj- Shahid Motahari Boulevard- Yasuj University of Medical Sciences Yasouj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)