drugset / Trial / NCT04852510

Amelioration of Polycystic Ovary Syndrome Related Disorders by Supplementation of Thymoquinone and Metformin

NCT04852510

Phase 2/3 Completed 253 enrolled Saudi German Hospital - Madinah
RandomizedParallel-groupOpen-labelTreatment

Summary

Objective: To investigate the potential benefit of adding Thymoquinone to Metformin in alleviating symptoms of polycystic ovarian syndrome. Methods: 207 overweight and obese PCOS Patients were divided into two groups. Patients in Group A, received Metformin 500 mg three times daily for 6 months. Patients in Group B, received a combination of Metformin 500 mg and Thymoquinone in the form of Black Cumin oil 500 mg capsules three times daily for 6 months. Follow up was done after 3 and 6 months from the beginning of the study for evaluation of menstrual cycle pattern, body mass index, Waist circumference, Hip circumference, and Waist / Hip ratio, Oral glucose tolerance test, Glycosylated Hemoglobin A1C, Superoxide dismutase activity and Malondialdehyde concentration.

Timeline

Start
2019-02-01
Primary completion
2020-08-31
Completion
2020-08-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Thymoquinone Small molecule 500 mg Oral
Comparator Metformin Small molecule 500 mg Oral