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IRCT201509295563N7 IRCT 2016-01-09 Vice chancellor for Research,Tabriz University Of Medical Sciences The effects of herbal mixture in infertile women with Polycystic ovary syndrome (PCOS): a randomized controlled trial Comparison of the efficacy of herbal medicine (Mixture) ‍ with Clomiphene citrate in treatment of Poly-cystic ovary syndrome (PCOS) and fertility rate in infertile women referring toTabriz Al-Zahra hospital. 2015-10-23 anticipated 102 Complete https://irct.ir/trial/5976 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants were divided into three groups (group 1: Clomiphene Citrate (CC); group 2: herbal mixture; and group 3: herbal mixture along with (CC) by random allocation software through randomized blocks of three and six with an allocation ratio of 1:1:1. For allocation concealment, according to sequence generation opaque and sealed envelopes numbered; each contain a letter designating the allocation. The first envelope was dedicated to first participant and this process was followed to the end of the research.Only the statistician was blind to the study, Blinding description: The statistician was blind to the study. 2-3 Female infertility. Intervention 1: " :Intervention group: " herbal medicine (Mixture) 700 mgs/day continuous for 3 cycles. Intervention 2: "Control group" Clomiphene Citrate 50-150 mg for 3 cycles. Intervention 3: '' :Intervention group: " herbal medicine (Mixture) 700 mgs/day continuous with Clomiphene Citrate 50-150 mg for 3 cycles. Yes - There is a plan to make this available What will be shared: age of patient When: September 2019 To whom: Academic member of universities Conditions: Ministry of Health and education Where to obtain: Womens Reproductive Health Research Center Tabriz University of Medical sciences , Dr Nava Ainehchi 00984135541221 How to obtain: Direct Contact to Womens Reproductive Health Research Center Tabriz University of Medical sciences- 2 months Comments:
public Arash Khaki
South shareati Street
Tabriz Iran (Islamic Republic of) 5138815941 +98 41 3555 6943 arashkhaki@yahoo.com PMC Pharmaceutical International Company scientific Dr.Elaheh Ouladsahebmadarek
Tabriz University Of Medical Sciences,Golgasht Street,
Tabriz Iran (Islamic Republic of) 5138665793 +98 41 3554 1221 wrhrcenter@gmail.com Tabriz University Of Medical Sciences Iran (Islamic Republic of) willing to participate in the study having at least two out of three of the Rotterdam criteria (2003) for the diagnosis of PCOS aged between 18–35 years old having body mass index (BMI) less than 30 not receiving any treatment at least in the last 3 months (wash out) 18 years 35 years Female patients with diabetes mellitus use of medications such as those helping ovulation or insulin sensitizers thyroid disorders cholesterol-lowering drugs smoking hypertension cardiovascular diseases Cushing syndrome allergy to Mentha spicata (spearmint), Zingiber officinale (ginger) ,Cinnamomum zeylanicum (cinnamon), and Citrus Sinensis (sweet orange) N97.0 Female infertility associated with anovulation Treatment - Drugs Treatment - Drugs Treatment - Drugs " :Intervention group: " herbal medicine (Mixture) 700 mgs/day continuous for 3 cycles. "Control group" Clomiphene Citrate 50-150 mg for 3 cycles '' :Intervention group: " herbal medicine (Mixture) 700 mgs/day continuous with Clomiphene Citrate 50-150 mg for 3 cycles. Treatment of ovarian cysts. Timepoint: Before the intervention, three months after intervention. Method of measurement: Ultrasound of the ovaries (ovarian size, number and size of follicles). Pregnancy. Timepoint: 3 months after taking medicinal plants (Citro Plus). Method of measurement: Positive BhcG. Vice chancellor for Research,Tabriz University Of Medical Sciences Approved 2015-10-03 Tabriz University Of Medical Sciences South shareati Street Tabriz East Azarbaijan Iran (Islamic Republic of)