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IRCT20150905023897N7 IRCT 2023-12-11 Tarbiat modares University 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 PCOS patients: A randomized double-blind trial 2023-11-01 anticipated 94 Complete https://irct.ir/trial/72397 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 2 Condition 1: Metabolic syndrome in PCOS patients. Condition 2: Insulin resistance in PCOS patients. Intervention 1: Intervention group: Treatment by Apple cider vinegar tablet 500 mg. Intervention 2: Control group: Treatment by placebo of Apple cider vinegar tablet. Yes - There is a plan to make this available What will be shared: Information on the main outcome of the study When: 1403 To whom: Academic researchers Conditions: Use for further research in the future Where to obtain: Email Addressing Responsible for Study How to obtain: Submit a request to study and follow up Comments:
public Shahideh Jahanian Sadatmahalleh
Jalal E Al Ahmad
Tehran Iran (Islamic Republic of) ۱۴۱۱۷۱۳۱۱۶ +98 21 2230 6480 Shahideh.jahanian@modares.ac.ir Tarbiat modares University scientific Shahideh Jahanian Sadatmahalleh
Jalal E Al Ahmad
Tehran Iran (Islamic Republic of) ۱۴۱۱۷۱۳۱۱۶ +98 21 2230 6480 shahideh.jahanian@modares.ac.ir Tarbiat Modares University Iran (Islamic Republic of) fertility age between 15-49 years Iranian women No pregnancy Have at least literacy for read and write No Mellitus Diabets according to primary FBS No chronic diseases affecting PCOS (such as congenital adrenal hyperplasia, Cushing's syndrome, hyperprolactinemia, thyroid dysfunction) Lack of consumption Anti lipids and Anti hypertensive and anti coagulative drugs during the last three months People are willing to participate in the study 15 years 49 years Female People with drug side effects Individuals unwilling to continue to participate in the study failure to comply with treatment protocol Treatment - Drugs Treatment - Drugs Intervention group: Treatment by Apple cider vinegar tablet 500 mg Control group: Treatment by placebo of Apple cider vinegar tablet Blood level of FBS. Timepoint: First of study and 12 weeks after intervention. Method of measurement: Blood biochemistry test. Blood level of Insulin. Timepoint: First of study and 12 weeks after intervention. Method of measurement: Blood biochemistry test. Level of Triglyceride. Timepoint: First of study and 12 weeks after intervention. Method of measurement: Blood biochemistry test. Level of total cholesterol. Timepoint: First of study and 12 weeks after intervention. Method of measurement: Blood biochemistry test. Blood level of LDL. Timepoint: First of study and 12 weeks after intervention. Method of measurement: Blood biochemistry test. Blood level of HDL. Timepoint: First of study and 12 weeks after intervention. Method of measurement: Blood biochemistry test. Blood level of testostrone. Timepoint: First of study and 12 weeks after intervention. Method of measurement: Blood biochemistry test. Weight. Timepoint: First of study and 12 weeks after intervention. Method of measurement: use of scale. Waist to hip ratio. Timepoint: First of study and 12 weeks after intervention. Method of measurement: Use of meter. Level of systolic and diastolic blood pressure. Timepoint: First of study and 12 weeks after intervention. Method of measurement: Use of mercury barometer. Menstrual dysfunction such as: Oligomenorrhea and amenorrhea. Timepoint: First of study and 12 weeks after intervention. Method of measurement: Patient statements. Clinical hyperandrogenemia. Timepoint: First of study and 12 weeks after intervention. Method of measurement: Blood biochemistry test and clinical symptom. Ultrasound view of the ovaries. Timepoint: First of study and 12 weeks after intervention. Method of measurement: Use of ultrasound. Sexual function. Timepoint: First of study and 12 weeks after intervention. Method of measurement: FSFI questionnaire. Quality Of life. Timepoint: First of study and 12 weeks after intervention. Method of measurement: MPCOSQ questionnaire. Tarbiat modares University Approved 2023-10-30 Ethics committee of Tarbiat Modares university Jalal E Al Ahmad Tehran Tehran Iran (Islamic Republic of)