Comparing the Effect of Clove Oil (Syzygium aromaticum) and Oral Contraceptive LD on Improvement of Clinical and Paraclinical Parameters of Polycystic Ovarian Syndrome (PCOS): A Triple Blind Randomized Controlled Trial

Comparison of the effect of clove oil with combined oral contraceptives (COCs) on the improvement of clinical and paraclinical symptoms of polycystic ovary syndrome.

The controlled clinical trial, with two parallel arms, triple-blind, randomized, phase 3 on 64 patients. RAS (Random Allocation Software) will be used for randomization.

Sixty women aged 18 to 45 referring to the clinics of Tabriz University of Medical Sciences and suffering from polycystic ovary syndrome, will be randomly assigned into two intervention groups of clove oil recipient and control (combined oral contraceptive) using block randomization method with a 1:1 allocation ratio. Both drugs will be completely identical to their placebo in terms of shape, color, and weight. The researcher, the patient, the data analyst, and the outcome examiner will be blinded

Inclusion criteria: Diagnosis of PCOS according to Rotterdam criteria, age 18 to 45 years, literacy, body mass index between 18.5 and 30, not using hormonal contraceptives Exclusion criteria: Relative and absolute contraindications to LD pills, suffering from amenorrhea, undergoing infertility treatment at the time of the study, previous surgery on one or both ovaries, allergy to clove oil, disorders that cause hyperandrogenism, thyroid disorders

The intervention group, every 28 days will receive one soft capsule of clove oil daily and one placebo tablet of COCs for 21 days and 7 days without using it for three cycles, and the control group, every 28 days will receive one placebo soft capsule of clove oil and one tablet COCs daily for 21 days and 7 days without taking it for three cycles. Original drugs will be identical in shape, color, and weight to their placebo counterparts.

Changes in serum DHEA levels; total testosterone; Average hirsutism score

Eligible people will be allocated into two intervention groups (receiving clove oil) and control (receiving COCs) using the random block method with the size of blocks of four and six with an allocation ratio of 1:1. The allocation sequence will be generated by the assistant of the researcher using RAS (Random Allocation Software). Medicines will be placed inside opaque packs numbered sequentially from 1 to 64 containing three pairs of packets. The intervention will consist of three cycles of 4 weeks. Each person will be given two packets in each cycle, one containing 28 soft capsules of clove oil or its placebo and the other containing 21 LD tablets or its placebo. They will be prepared according to the allocation sequence by a person not involved in the research.

The first group every 28 days will receive one daily soft capsule of clove oil and one placebo tablet of COCs for 21 days and 7 days without using it for three cycles and the second group will receive every 28 days, one daily soft placebo capsule of clove oil and one tablet of COCs for 21 days and 7 days without taking it for three cycles. Original drugs will be identical in shape, color, and weight to their placebo counterparts. Participants, the principal investigator, health care personnel, those assessing the outcome and the safety and data monitoring committee, and those preparing the draft of the article will be blinded.

Data on the main outcome will be published

Six months after printing the results

Researchers at institutions have access to data

In order to help scientific progress in the field of research

farshbafa@tbzmed.ac.ir

Scientific approval of the applicant by Tabriz University of Medical Sciences