To evaluate the effect of garlic tablet on metabolic syndrome in PCOS patients : A Randomized Double-blind Placebo-controlled Trial

The effect of garlic tablets on metabolic syndrome in patients with poly cystic ovary syndrome(PCOS)

A randomized, double-blind, placebo-controlled clinical trial with control group in parallel with a calculated sample size of 36 patients in each group totaling 72 patients.

Samples were selected from women referring to the infertility clinic of Arash Women General Hospital who met the inclusion criteria and were randomly assigned to one of two intervention or control groups. The intervention duration is 8 weeks and these patients will be evaluated at the beginning of the study and at the end of the eighth week.

Inclusion criteria: age 15 to 49 years / unwilling to participate in the study / not pregnant / not having diabetes Mellitus / not having other chronic illnesses / not taking blood lipids and anticoagulants / minimal reading and writing literacy / Consume a maximum of one garlic per day Exclusion criteria: unwillingness to continue participation / occurrence of any side effects caused by medication and intervention.

Intervention group: Garlic tablets 500 mg twice daily for 8 weeks along with other medications such as Metformin Control group: Garlic placebo in the same dose and form for 8 weeks.

Plasma Level of FBS/ Triglyceride/ HDL/Cholesterol total Level of systolic and diastolic blood pressure Waist-to-hip ratio and weight (WHR)

Completion of the sampling process and statistical analysis led us to update the recorded information of different sections of this trial in IRCT. As we have believed that this study might hold enormous potential for improving promising therapeutic agents to benefit patients who are suffering from various manifestations of endometriosis, especially endometrioma. Unfortunately, while updating the information related to the actual recruitment start/end dates, we noticed an inadvertent error in recording the expected recruitment start and end dates of the sampling, and a need has been felt on the imperative for transparency, accountability in order to fix that error and explain its causes to re-establish researchers’ trust in this clinical trial’s accuracy and reliability. All available evidence, including the date of approval of this clinical trial in the ethics committee of Tarbiat Modares University (IR.MODARES.REC.1398.142) and the date of entry of the researcher to the master's degree (1397-98 academic year) indicate an inadvertent error in the registration of this study and make the possibility of conducting this study in that time (before registration) unfeasible. We take full responsibility for the situation and all of patients’ consents and questionnaire forms with detailed for the current study are available upon any requests. In addition, the simultaneous recruiting of patients and the coronavirus pandemic and its lockdown resulted in study participants’ inaccessibility and trial personnel for in-person scheduled study visits and/or follow-up led to prolong sampling process and its postponement.

Patients are randomly divided into two groups according to the blocking method and double blind

The researcher and patient will be unaware of the treatment and grouping of the study. For this purpose, Garlic tablets and placebo are coded by a research center. The lead researcher treats patients in a double-blind manner based on the drug package code. The code for the drug package is recorded on the personal information form, and the researcher who completes the information form will not be informed of the type of treatment.

Information on the main outcome of the study

1400

Academic researchers

Use for further research in the future

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