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FAQ on this study

What is the objective of the study?

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 of patients with polycystic ovary syndrome and insulin resistance.

How long will the study  last?

If you are eligible and decide to join this clinical research study, you will take part for up to 6months.

What kind of tests and exams will I have to take while I am in this study?

  1. Test for Lipid profile [total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides level] : Time Frame 3 and 6  months
  2. Improvement of glucose tolerance [reduction of FPG and 2-hour PPPG] from baseline to Month 3rd and Month 6th (end of study)
  3. Change of waist circumference [ Time Frame: 1, 2, 3, 4, 5, and 6 months ]
    1, 2, 3, 4, 5, and 6 months
  4. Response rate: presence of ovulation [ Time Frame: menstrual cycle of Month 3rd up to that of Month 6th ]
    Presence of ovulation will be evaluated using trans-vaginal USG to find dominant follicle(s), at the day/period of ovulation, starting from menstrual cycle of Month 3rd up to Month 6th. Measurement of progesterone level will be performed 7 days after the finding of dominant follicle on USG examination to confirm the presence of ovulation.
  5. Change of endometrium thickness [ Time Frame: 3 to 6 months ]
    Change of endometrium thickness will be measured by using trans-vaginal USG at basal condition and at the day/period of ovulation
  6. Improvement of S/A ratio [ Time Frame: 3 to 6 months ]
    Improvement from baseline of the S/A ratio (defined as the ratio between stromal and total area of median ovarian section) will be measured using trans-vaginal USG (trans-longitudinal measurement) at Baseline, menstrual cycle of Month 3rd, and menstrual cycle of Month 6th at basal condition.
  7. Improvement in Ferriman-Gallwey Score [ Time Frame: 3 and 6 months ]
    Improvement in Ferriman-Gallwey Score from baseline to Month 3rd and Month 6th (the end of study)
  8. Reduction of free testosterone level [ Time Frame: 6 months ]
    Reduction of free testosterone level from baseline to Month 6th (end of study)
  9. Change of luteinizing hormone (LH) level [ Time Frame: 6 months ]
    Change of luteinizing hormone (LH) level from baseline to Month 6th (end of study)
  10. Change of luteinizing hormone (LH) / follicle stimulating hormone (FSH) ratio [ Time Frame: 6 months ]
    Change of luteinizing hormone (LH) / follicle stimulating hormone (FSH) ratio from baseline to Month 6th (end of study)
  11. Liver function [ Time Frame: 6 months ]
    Liver function (levels of serum AST, ALT, alkaline phosphatase) will be measured at baseline and Month 6th (end of study)
  12. Renal function [ Time Frame: 6 months ]
    Renal function (levels of serum creatinine, BUN) will be measured at baseline and Month 6th (end of study)
  13. Number of adverse events and subjects with events [ Time Frame: During 6 months ]
    Adverse events as well as number of events and subjects experiencing the events will be observed and evaluated throughout study period (6 months) and until all adverse events have been recovered or stabilized

How often will I have to visit study site?

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.

FAQ on Clinical Trials

What is a clinical research study?

Below are the definitions of “research” from several governing bodies:

Food and Drug Administration (FDA) has defined "clinical investigation" to be synonymous with "research". "Clinical investigation" means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA...or the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit.

U.S Department of Health and Human Services (HHS) has defined "research" as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

National Institute of Health (NIH) defines Clinical research as research that directly involves a particular person or group of people, or that uses materials from humans, such as their behaviour or samples of their tissue. NIH defines a Clinical Trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioural outcomes.

What happens in research study?

Research studies are done to test whether new products are safe and work against disease. Study products are tested to see how they compare to standard treatments or to no treatment if there is not presently one. Many studies require that neither the patient nor the doctor know whether the patient is receiving the study treatment, the standard treatment, or a placebo (an inactive substance that looks like the drug being tested). In other words, some people may be getting no treatment at all.

What are the phases of clinical drug trial?

Clinical drug trials are conducted in phases. The trials at each phase have a different purpose and help researchers answer different questions:

In Phase 1 trials, researchers test an experimental drug or treatment for the first time in a small group (typically 20 to 80 people) to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 trials, the experimental study drug or treatment is given to a larger group of people (typically 100 to 300) to see if it is effective and to further evaluate its safety.
In Phase 3 trials, the experimental study drug or treatment is given to large groups of people (typically 1,000 to 3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
Phase 4 trials are conducted on drugs after the US Food and Drug Administration (FDA) has approved them for marketing, in order to provide additional information on the drug's risks, benefits, and optimal use.

Why should I join a clinical research study?

Without research volunteers like you, medical discoveries would not be possible. Research volunteers can help discover the next cure for a disease, help doctors understand how to diagnose an illness better, or understand which health approaches work best for specific groups of people. YOU can help make research better!