Evaluation of therapeutic effects of crocina (saffron tablets) in patients with polycystic ovary syndrome: a randomized double-blind clinical trial

1) Determine the effect of crocin consumption on hirsutism in patients with PCOS 2) Determine the effect of crocin consumption on acne in patients with PCOS 3) Determine the effect of crocin intake on body mass index in patients with PCOS 4) Determine the effect of crocin consumption on menstrual disorder in patients with PCOS 5) Determination of the effect of crocin on laboratory parameters of FBS, LH, DHEA, FSH in patients with PCOS

Fifty patients with confirmed PCOS and known hirsutism will be studied by the Rotterdam Criteria. Patients take 15 mg crocina tablets once daily, or placebo tabletsfor 12 weeks to complete three full cycles of menstruation.

Baghaeipour and Khatam Al-Anbia Clinic in Yazd

Inclusion criteria: 1) Age 18 to 44 years 2) A well-known patient with polycystic ovary syndrome 3) Adequate literacy to understand the study, drug use and potential side effects Exclusion criteria: 1) drug intolerance 2) Not taking the medicine correctly 3) Serious medical conditions that the patient cannot regularly attend periodic visits including severe cardiovascular disease such as angina or myocardial infarction, recent stroke, psychiatric disorders, active concussion, and anemia 4) Use estrogenic or progestin drugs to regulate the monthly cycle 5) Use of antidepressants including SSRI, SNRI, TCA, MAOI 6) Failure to sign a written consent 7) Pregnancy and lactation

Patients will be randomly divided into two groups of recipients including the first group (metformin and placebo) and the second group (combination of crosina and metformin) (25 patients each)

Changes in serum levels of FBS, gonadotropins (LH and FSH), dihydroepiandrosterone dione

In this study, 50 patients are randomly allocated into two treatment groups (A and B). Block randomization method will be used for random allocation. Ten blocks of five are considered. The generated permutations include the letters A and B, which are repeated (for example, ABAAB) in each permutation. These permutations are generated using Random allocation software version 1. For this purpose, the generated list by the software is from 1 to 50, which are arranged in 10 blocks of five in order. To run this software output, we give the first qualified person number 1 and the last person will receive number 50. To consider blinding in random allocation, the list is given to another person outside the study and using short message service (SMS) before assigning the type of treatment according to the number of eligible people is asked and thus people enter the study. In addition, in the software output, both numbers 1 to 50 and the permutations of the letters A and B can be seen

All stages will be covered by the patient, physician, and evaluator. The first presenter identifies the sequence of assignment of patients according to the order of entry of the patients to the study and places the drugs in a uniform envelope and identifies them with A or B codes. He then identifies the medications that are appropriate for each individual according to the above description and puts them in special envelopes and delivers them to patients.