Effectiveness of metformin, DLBS 3233 and Vaccinium myrtillus extract to improve the Rotterdam criteria and HOMA-IR score in women with chronic polycystic ovarian syndrome (PCOS)
Phase 2
Completed
- Conditions
- chronic polycystic ovarian syndrome
- Registration Number
- TCTR20221016001
- Lead Sponsor
- ocal, in Arifin Achmad Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 39
Inclusion Criteria
All patients who satisfied the Rotterdam PCOS criteria for chronic polycystic ovarian syndrome, which includes oligomenorrhea or amenorrhea and at least one of the two symptoms of hyperandrogenism (clinical or biochemical proof of it) or polycystic ovaries on ultrasound, ready to take part in research and willing to follow research protocol, and HOMA-IR > 2.0.
Exclusion Criteria
(1) People with comorbid conditions; (2). Treatment for insulin sensitivity within three months before the study or during the study; (3) Drug hypersensitivity reactions that are well-known; and (4) A body mass index that is less than 20 or higher than 50 kg/m2.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rotterdam criteria and HOMA-IR Three months Direct assessment
- Secondary Outcome Measures
Name Time Method Occurrence of pregnancy and the treatment side effects Three months Interview,Improvement of the BMI, upper arm circumference, abdominal circumference and endometrial thickness Three months Direct assessment