The effect of apple cider vinegar tablet on metabolic syndrome and insulin resistance in PCOS patients: A randomized double-blind trial

The effect of apple cider vinegar tablet on metabolic syndrome and insulin resistance in polycystic ovary syndrome patients

A randomized, double-blind, placebo-controlled clinical trial with control group in parallel with a calculated sample size of 47 patients in each group totaling 94 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 12 weeks and these patients will be evaluated at the beginning of the study and at the end of the twelfth week.

Inclusion criteria: age 15 to 49 years- Iranian nationality- willing to participate in the study- not pregnant- have at least literacy for read and write- no Mellitus Diabets according to primary FBS- no chronic diseases affecting the polycystic ovary syndrome - lack of consumption Anti lipids and Anti hypertensive and anti coagulative drugs during the last three months/ Exclusion criteria: occurrence of any side effects caused by medication and intervention- unwillingness to continue participation - failure to comply with treatment protocol

Intervention group: Apple cider vinegar tablets 500 mg three times daily for 12 weeks with other medications/ Control group: Apple cider vinegar placebo in the same dose and form for 12 weeks.

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

In this study, we will use the restricted randomization method (block randomization type). Blocking is often with the purpose Creating a balance in the number of samples assigned to each of the studied groups should be used. This feature allows researchers to have the same number of samples assigned to each of the studied groups in cases where intermediate analyzes are needed during the sampling process. The size of all the blocks is equal and we will have 4 blocks in this two-group experiment (including 2 participants in the intervention group and 2 participants in the control group). The randomization tool is also used from random sequence generation software (random allocation software), which in addition to simple randomization, these random sequence generation software are also capable of generating random sequence by block method. In order to conceal, we will use Concealment Allocation, which refers to the method used to perform a random sequence on the participants in the study, so that the allocated group is not known before the allocation of the individual. By using sealed and non-transparent envelopes with a random sequence (envelopes opaque, sealed, numbered Sequentially (in this method, each of the random sequences created on a registration card, and the cards inside the letter envelopes) They are placed in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Then the lid of the letter envelopes is glued and placed in a box in order. At the time of the registration of the participants, based on the order of entry of the qualified participants into the study, one of the envelopes will be opened in order and the assigned group of that participant will be determined.

The researcher and patient will be unaware of the treatment and grouping of the study. For this purpose, apple cider vinegar tablet 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

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