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IRCT20170315033085N3 IRCT 2018-06-16 Mashhad University of Medical Sciences Investigation of the effect of chamomile on ovulation induction in patients with polycystic ovary syndrome Investigation of the effect of chamomile on ovulation induction and hormonal and clinical parameters in patients with polycystic ovary syndrome 2018-02-07 anticipated 70 Complete https://irct.ir/trial/30334 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization is done through providing drug-containing envelopes which are numbered based on random allocation table by someone outside the study. Afterwards, envelopes are handed to the doctor to give them to patients in turn, Blinding description: This is a double-blinded study in which researcher and patient are unaware of the type of intervention which means researcher and patient have no knowledge of the content of the envelope and treatment method. 2-3 Polycystic ovarian syndrome. Intervention 1: Intervention group: Patients daily receive two 500-mg chamomile capsules for 3 months. Intervention 2: Control group: Patients daily receive two placebo capsules (which are similar to chamomile capsules in color but without effective ingredient) with similar dose for 3 months. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable When: Data can be accessible 6 months after results are published To whom: Data will be available for researchers in universities and other scientific institutes Conditions: Carrying out analysis on data is permitted Where to obtain: Data can be accessible through sending an email to the corresponding author How to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. Comments:
public Azam Akbari Lor
Ghaem hospital, Ahmad Abad Ave
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2477 Akbarila941@mums.ac.ir Mashhad University of Medical Sciences scientific Malihe Afiat
Emam Reza hospital, Emam Reza Sq, Ebne-Sina Ave
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 2609 afiatm@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Normal maturation Thyroid test is within normal range Having Rotterdam criteria for polycystic ovary syndrome Patient's age is between 18 and 35 Not having a recent history of surgical treatment and other treatment for polycystic ovary syndrome 18 years 35 years Female Use of sex steroids (such as birth control pills, hormone therapy, androgenic drugs) Use of chemical or herbal medicine Use of cigarettes or hookahs E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Intervention group: Patients daily receive two 500-mg chamomile capsules for 3 months. Control group: Patients daily receive two placebo capsules (which are similar to chamomile capsules in color but without effective ingredient) with similar dose for 3 months. Rate of ovulation induction in patients with polycystic ovary syndrome. Timepoint: Investigate of the ovarian follicles is done on 12th day of the first cycle and also on the 3rd and 12th days of the third cycle and in case of not having menstruation, at the end of 90th for all patinets. Method of measurement: Transvaginal ultrasound. Total testostrone rate. Timepoint: measuring testostrone rate at the beginning of the study (before intervention) and at the end of the study. Method of measurement: ELISA method. Mashhad University of Medical Sciences Approved 2017-11-07 Ethics committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)