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

NCT04852510 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2021-04-21

No results posted yet for this study

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.

Conditions

  • Polycystic Ovary Syndrome (PCOS)

Interventions

DRUG

Metformin Versus a combination of Metformin and Thymoquinone (TQ)

Patients were divided into two groups (A and B) using a computer-based software Open Epi version 3.21. Patients in Group A, received Metformin 500 mg three times daily (5) with meals for 6 months (Metfor® 500 mg, Metformin hydrochloride tablets. TABUK Pharmaceutical. KSA). Patients in Group B, received a combination of Metformin 500 mg three times daily with meals (Metfor® 500 mg, Metformin hydrochloride tablets. TABUK Pharmaceutical. KSA) and Thymoquinone (TQ) in the form of Black Cumin oil (Cumin Mar® Black cumin oil 500 mg soft gel capsules, MARNYS. Spain) three times daily before meals for 6 months.

Sponsors & Collaborators

  • Saudi German Hospital - Madinah

    lead OTHER

Principal Investigators

  • Islam Mohamed Magdi Ammar, M.D. · Saudi German Hospital - Madinah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04852510 on ClinicalTrials.gov