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

Studying the effect of garlic, ginger, olive oil and lemon juice extracts on blood pressure, blood sugar and lipid profile in diabetic patients

A controlled clinical trial with parallel groups, double-blind, randomized, on 60 patients, will be conducted using the Randomization.com or WinPepi software.

This interventional study will be conducted in the diabetes clinic, Shahid Mofatteh Clinic, affiliated with Yasuj University of Medical Sciences. Diabetic patients introduced by the endocrinologist will be referred to the nutrition clinic in the clinic. Based on the list, the nurse or nutritionist or resident secretary in the ward will give the patients a number and a type of capsule specified for that number, and will deliver this assignment and numbering to the nutrition group.

Inclusion criteria: Diagnosis of type 2 diabetes, HbA1c level between 7 and 8%, age 18 to 65 years, cholesterol above 200 mg/dL, and ability to take capsules daily. Exclusion criteria: Pregnancy or breastfeeding, age less than 20 years, concurrent participation in other clinical studies.

Intervention group: Patients who will receive one capsule of a combination of garlic, ginger, olive oil, and lemon juice daily for 8 weeks. Control group: Patients who will receive one cellulose capsule daily for 8 weeks.

Hemoglobin A1C Low-density lipoprotein High-density lipoprotein Triglycerides Cholesterol

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.

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.

Data on primary variables will be shareable after de-identifying individuals

The access period starts 6 months after the results are published

The data will only be available to researchers working in academic and scientific institutions

Data will be allowed to be reanalyzed for use in secondary studies such as meta-analyses

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,

After receiving approval from Yasuj University of Medical Sciences (one week to one month), thedata will be sent to the applicant