Status:
COMPLETED
Amelioration of Polycystic Ovary Syndrome Related Disorders by Supplementation of Thymoquinone and Metformin
Lead Sponsor:
Saudi German Hospital - Madinah
Conditions:
Polycystic Ovary Syndrome (PCOS)
Eligibility:
FEMALE
18-35 years
Phase:
PHASE2
PHASE3
Brief 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 divide...
Detailed Description
This randomized clinical trial was conducted in the department of Obstetrics and Gynaecology at the Saudi German Hospital, Madinah-KSA, during the period from February 2019 to August 2020. The study i...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
253 Patients enrolled
Trial Details
Trial ID
NCT04852510
Start Date
February 1 2019
End Date
August 31 2020
Last Update
April 21 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Saudi German Hospital
Al Madīnah, Madinah, Saudi Arabia, 41311