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Study Test Site

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.
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Detailed Description

There will be 3 groups of treatment (N = 186), each consist of 62 subjects, as the following:

Treatment I : DLBS3233 100 mg once daily
Treatment II : Metformin XR 750 mg twice daily
Treatment III : DLBS3233 100 mg once daily and Metformin XR 750 mg twice daily.


Laboratory examination to evaluate metabolic efficacy parameters will be performed at baseline, Month 3rd, and end of study (Month 6th).
Clinical and laboratory examination to evaluate the reproductive efficacy parameters using trans-vaginal USG and biomarkers (such as reproductive hormones) will be performed at baseline to the end of study.
Safety examination will be performed at baseline and end of study. Occurrence of adverse event will be observed along the study conduct.

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Call 1800-9860-568 now to find out if you are eligible.

Age

18 - 40

Gender

Female

NCT ID

NCT0011111

Phase

-1

Status

Recruiting Now

Medical Condition

Insulin Resistance

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Medical Condition

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The Study

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About Clinical Trials

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Your Journey

01
Receiving the medication

You would receive etanercept (Enbrel) twice a week for 12 weeks and then once a week for 12 weeks. Etanercept, as well as study related medical care, is provided at no cost.

02
Visiting the study site

Study participation involves approximately 8 visits to your local study center over 6 to 7 months.

03
Follow-up

There would also be a follow-up telephone call 30days after completing the study. No visits are required after participation is complete.

Call 1800-9860-568 now to find out if you are eligible.