Polycystic Ovary Syndrome (PCOS) Clinical Trial
Official title:
The Role of DLBS3233 in the Management of Polycystic Ovary Syndrome (PCOS)
This is a 2-arm, randomized, double-blind, double-dummy, and controlled clinical study, with 6 months of treatment to evaluate the clinical and metabolic efficacy of DLBS3233 in improving reproductive parameters and to evaluate the safety of DLBS3233 in women with polycystic ovary syndrome compared with metformin, as an active control.
There will be 2 groups of treatment; each group will consist of 62 subjects with the
treatment regimens :
- Treatment I : 1 capsule of DLBS3233 100 mg (once daily) and 1 placebo caplet of
Metformin XR (twice daily)
- Treatment II : 1 caplet of Metformin XR 750 mg (twice daily) and 1 placebo capsule of
DLBS3233 (once daily) for 6 months of treatment.
Clinical examination to evaluate the efficacy of the investigational drug will be performed
at baseline and every interval of 1 month.
Laboratory examinations to evaluate the metabolic efficacy parameters and ultrasonography
(USG) examination will be performed at baseline, Month 3rd, and end of study (Month 6th). In
addition to that, USG will also be performed about 2 weeks after Month 3rd (Month 3.5th) and
after Month 5th (Month 5.5th).
Laboratory examinations to evaluate the reproductive efficacy parameters (reproductive
hormone levels) and safety, at baseline and Month 6th (end of study).
General counseling on lifestyle modification will be provided to the subjects by the assigned
Nutritionist. All study subjects should follow a lifestyle modification. Evaluation on
subjects' performance on lifestyle modification will be conducted every follow-up visit by
Investigator, but particularly at baseline, Month 3rd, and end of study (Month 6th) by the
Nutritionist.
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