drugset / Trial / NCT01733459
Efficacy and Safety of DLBS3233 in Subjects With Polycystic Ovary Syndrome (PCOS)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2013-03
- Primary completion
- 2018-04
- Completion
- 2018-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DLBS3233 | Traditional medicine (herbal / TCM) | 100 mg | Oral |
| Comparator | Metformin | Small molecule | 750 mg | Oral |