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

• Status: Completed
• Trial end date: 2020-08-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Saudi German Hospital - Madinah
• Treatments: Metformin

Criteria

Inclusion criteria:

• Age of 18 to 35 years

• Overweight and obese PCOS patients (overweight defined as body mass index (BMI) 25-29.9 kg/m2 and obesity defined as BMI ≥ 30 kg/m2).

• History of amenorrhea or oligomenorrhea with or without hirsutism. Amenorrhea was defined as absence of menstruation for six or more months. Oligomenorrhea was defined as cycle interval of more than 35 days but less than 6 months.

• PCOS diagnosed according to the 2004 Rotterdam ESHRE/ASRM Consensus workshop, with presence of at least 2 out of 3 criteria: oligo- and/or anovulation, clinical and/or biochemical hyperandrogenism, and polycystic ovarian morphology identified by ultrasound with more than 12 small antral follicles in an ovary.

• Prediabetes defined by the American Diabetes Association 2014, as fasting plasma glucose (FPG) levels of 100 to 125 mg/, or impaired glucose tolerance (IGT) defined as 2-hour readings of 140 to 199 mg/dL in the oral glucose tolerance test (OGTT). Also, patients who had their Glycosylated Hemoglobin A1C levels between 5.7% and 6.4%.

Exclusion criteria were:

• Lean or average weight PCOS with BMI < 25 kg/m2, morbidly obese patients with BMI ≥ 35 kg/m2.

• Patients suffering from any other metabolic disorders.

• History of receiving any hormonal treatment or any drug affecting carbohydrate metabolism 3 months prior to the beginning of the study.

• Inability to attend the regular follow up visits.

• Already known and recently diagnosed diabetic patients. According to the American Diabetes Association 2014 (16), diabetes mellitus was defined as Glycosylated Hemoglobin A1C levels ≥ 6.5% or FPG ≥ 126 mg/dL or 2-hour plasma glucose readings ≥ 200 mg/dL during 75 g OGTT, or presence of classic symptoms of hyperglycemia with random plasma glucose levels ≥ 200 mg/dL.

• Thyroid diseases

• Hyperprolactinemia