drugset / Trial / NCT01999686

PCOS Treatment Using DLBS3233, Metformin, and Combination of Both

NCT01999686 ↗

Phase 3 Completed 186 enrolled Dexa Medica Group
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a 3-arm, randomized, double-blind, double-dummy, and controlled clinical study over 6 months of treatment to evaluate the metabolic and clinical efficacy as well as the safety of DLBS3233 alone, metformin and combination of both, in improving metabolic and reproductive parameters.

Timeline

Start
2014-10
Primary completion
2019-02
Completion
2019-05

Drugs

EvaluationDrugModalityDoseRoute
Subject DLBS3233 Traditional medicine (herbal / TCM) 100 mg Oral
Subject Metformin XR Small molecule 750 mg Oral