]>
IRCT20210730052027N1 IRCT 2021-08-26 Yazd University of Medical Sciences Evaluation of therapeutic effects of crocina (saffron tablets) in patients with polycystic ovary syndrome: a randomized double-blind clinical trial Evaluation of therapeutic effects of crocina (saffron tablets) in patients with polycystic ovary syndrome: a randomized double-blind clinical trial 2021-08-16 anticipated 50 Complete https://irct.ir/trial/57958 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: All patients who enter this study will fill out and sign the consent form. A questionnaire will be designed to provide information on patients' conditions, and all patients will be asked all questions regarding entry and exit conditions. Based on this and consultation with the physician to decide on entry or exit of patients. After identifying and selecting patients, they receive written consent (after explaining its content to the student) and eligible patients enter the phase. They will be randomly assigned to the study to receive one of the interventions. patients will be selected by referrals to the Women's Clinic of Shahid Rahnemoon Hospital in Yazd and will be randomly assigned, Randomization description: 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, Blinding description: 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. 2 Polycystic ovary syndrome. Intervention 1: Intervention group: 25 patients diagnosed with PCOS based on the Rotterdam Criteria will take 15 mg of Crosina (Saffron as an active ingredient) once a day and metformin 500 mg three times a day for 12 weeks. Intervention 2: Control group: 25 patients diagnosed with PCOS based on the Rotterdam Criteria will take a placebo of Crosina tablet once a day and metformin 500 mg three times a day for 12 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Ahdieh Asadi
ایران، یزد، بلوار پروفسور حسابی
Yazd Iran (Islamic Republic of) ۸۹۱۵۱۷۳۱۴۹ +98 35 3820 3419 asadiahdie@gmail.com Yazd University of Medical Sciences scientific Fatemeh Saghafi
Professor Hesabi Blvd., Yazd Province, Yazd, Iran
Yazd Iran (Islamic Republic of) ۸۹۱۵۱۷۳۱۴۹ +98 35 3820 3419 F.saghafi@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) Age 18 to 44 years Adequate literacy to understand the study, drug use and potential side effects Patient known with polycystic ovary syndrome 18 years 44 years Female Serious medical conditions that the patient cannot regularly attend periodic visits include severe cardiovascular disease such as angina or myocardial infarction, recent stroke, psychiatric disorders, active concussion, and anemia Taking estrogenic or progestin drugs to regulate the monthly cycle Antidepressants (SSRI, SNRI, TCA, MAOI6) Failure to sign written consent Pregnancy and lactation E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Intervention group: 25 patients diagnosed with PCOS based on the Rotterdam Criteria will take 15 mg of Crosina (Saffron as an active ingredient) once a day and metformin 500 mg three times a day for 12 weeks. Control group: 25 patients diagnosed with PCOS based on the Rotterdam Criteria will take a placebo of Crosina tablet once a day and metformin 500 mg three times a day for 12 weeks. Changes in Serum Levels of Gonadotropins (LH and FSH) Dihydroepiandrosterone Dione (DHEA) Fasting Blood Glucose. Timepoint: Before the intervention, after completion of the intervention. Method of measurement: Blood sample. Measuring fasting blood sugar. Timepoint: Before the intervention, after completion of the intervention. Method of measurement: Blood sample. Changes in Serum Levels of Dihydroepiandrosterone Dione (DHEA). Timepoint: Before the intervention, after completion of the intervention. Method of measurement: Blood sample. Body Mass Index. Timepoint: Before the intervention, after completion of the intervention. Method of measurement: Based on the Body Mass Index. Hirsutism. Timepoint: At the beginning of the study and at 15,30,45,60,75,90 days after the intervention. Method of measurement: Clinical case and Ferriman-Galwey criteria and also subjectively as a patient self-report for improved hirsutism with the modified (Dermatology Quality of Life Index). Yazd University of Medical Sciences Approved 2020-11-10 faculty of ethics of medical sciences - shahid sadoughi university of medical sciences Gomnam shohada boulevard - shahid sadoughi university of medical sciences Yazd Yazd Iran (Islamic Republic of)