Clinical trial · Interventional
PCOS Treatment Using DLBS3233, Metformin, and Combination of Both
Polycystic Ovary Syndrome Treatment Using DLBS3233, Metformin, and Combination of Both, and Its Relation to Fertility
NCT01999686CI-TRIAL-00038795POSITIFcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Insulin Resistance | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome (PCOS) | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DLBS3233 | Drug | — | UNRESOLVED |
| Metformin XR | Drug | Metformin | ALIAS |
| Placebo DLBS3233 | Drug | — | UNRESOLVED |
| Placebo metformin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Treatment I : DLBS3233
- description
- DLBS3233 100 mg capsule once daily, and Placebo metformin caplet twice daily; orally, for 6 months
- interventionNames
- Drug: DLBS3233
- Drug: Placebo metformin
- type
- ACTIVE_COMPARATOR
- label
- Treatment II : Metformin
- description
- Metformin XR 750 mg caplet twice daily, and Placebo DLBS3233 once daily; orally, for 6 months
- interventionNames
- Drug: Metformin XR
- Drug: Placebo DLBS3233
- type
- EXPERIMENTAL
- label
- Treatment III : Combination DLBS3233 and Metformin
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria:
1. Signed written informed consent prior to participation in the study.
2. Female subjects in reproductive age (i.e. 18-40 years) willing to conceive.
3. Subject with a diagnosis of polycystic ovary syndrome confirmed by two of the following (Rotterdam Criteria):
* Hyperandrogenism (defined by elevated free testosterone concentration; or Ferriman-Gallwey Score of ≥ 8).
* Ovarian dysfunction indicated by menstrual irregularity: oligomenorrhea (cycles of \> 35 days), or amenorrhea (no menses in the last of 3 months) after negative screening pregnancy test.
* Polycystic ovary as shown by ultrasonography (USG).
4. Subject with insulin resistance defined by : HOMA-IR of \> 2.00.
5. Subject with body mass index (BMI) of 19-35 inclusive.
6. Able to take oral medication.
Exclusion Criteria:
1. Pregnant or lactating women (urinary pregnancy test will be applied at screening).
2. Based on previous or current medical (either laboratory or clinical) examination, subjects known to have any of the following conditions:
* Cushing's syndrome, late onset of congenital adrenal hyperplasia, androgen-secreting tumors, uncontrolled thyroid disease, hyperprolactinemia.
3. Known to have the following medical condition:
* Diabetes mellitus,
* Uncontrolled hypertension
* Symptomatic cardiovascular diseases:
* Acute or chronic infections at baseline.
* Any known malignancies.
4. History of gynecological surgery.
5. Impaired renal function
6. Impaired liver function
7. Medically-assisted weight loss with medications or surgical procedures.
8. Currently having laparoscopic ovarian diathermy (LOD).
9. Currently under treatment with in vitro fertilization (IVF) techniques.
10. Have been regularly taking any of the following medications, within ≤ 3 months prior to screening, such as:
* Clomiphene citrate
* Insulin sensitizers, i.e. metformin and thiazolidinediones
* Aromatase inhibitors, such as: anastrozole, letrozole
* Glucocorticoids
* Gonadotropins
* Gonadotropin-releasing hormone agonists (GnRHa)
* Oral contraceptive pills (OCPs)
* Antiandrogens, such as: spironolactone, cyproterone acetate (CPA), and flutamide
* Any traditional or herbal medicines
11. Participating in other clinical trial within 30 days prior to screening.References
Publications (1)
- DERIVEDHidayat ST, Mulyantoro I, Damas S, Tjandrawinata RR. The Effect and Safety Assessment of Metformin and DLBS3233 (A Bioactive Fraction of Lagerstroemia speciosa and Cinnamomum burmannii) on Improving Metabolic Parameters in Women with Polycystic Ovary Syndrome. Int J Womens Health. 2023 Jul 4;15:971-985. doi: 10.2147/IJWH.S409685. eCollection 2023. PMID 37424700