Comparative assessment of the effect of complementary treatment with Cinnamon and Turmeric capsules on Polycystic Ovarian Syndrome: A triple blind clinical trial

Phase 2

Recruiting

• Conditions: Polycystic Ovarian Syndrome.; Polycystic ovarian syndrome; E28.2

• Registration Number: IRCT20201022049117N1
• Lead Sponsor: Tarbiat Modares University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

Age 18 to 45 years
Diagnosis of PCOS by a gynecologist (according to clinical, laboratory, and imaging symptoms)
Not pregnant now
Failure to receive infertility treatment
Do not take hormonal drugs or any medication for at least the last 3 months
Do not take any medication or nutritional supplements
More than 4 years after the onset of menarche
Absence of severe underlying disease

Exclusion Criteria

Do not take the desired drugs for at least 7 days a month
The unwillingness of the participant to continue the participation for any reason
Occurrence of any adverse or intolerable complications during the study due to the patient's complaint, or physician's diagnosis
Occurrence of pregnancy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Irregular menstrual frequency. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: History, clinical and paraclinical examinations.;Hirsutism. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: History, clinical and paraclinical examinations.;Serum testosterone levels. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: History, clinical and paraclinical examinations.;Serum FAI (Free Androgen Index). Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: History, clinical and paraclinical examinations.;Polycystic ovary. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: History, clinical and paraclinical examinations.

Secondary Outcome Measures

Name	Time	Method
HOMA-IR (Homeostasis Model Assessment - Insulin resistance ). Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Paraclinical examinations.;FBS (Fasting blood sugar). Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Paraclinical examinations.;(MDA) Malone di aldehyde. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Paraclinical examinations.;FSH ( Follicle-stimulating Hormone). Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Paraclinical examinations.;LH ( luteinizing hormone ). Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Paraclinical examinations.