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Clinical Study to Evaluate the Safety and Efficacy of a Unani Formulation in the Management of Mutal ?zima Mabya ?-i-Muta‘ddad al-Kis ?t (Polycystic Ovarian Syndrome)

A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to Evaluate the Safety and Efficacy of a Unani Formulation in the Management of Mutal ?zima Mabya ?-i-Muta‘ddad al-Kis ?t (Polycystic Ovarian Syndrome) - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064942
Enrollment
60
Registered
2024-03-28
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E282- Polycystic ovarian syndrome

Interventions

Intervention1: UNANI FORMULATION (HERBAL SYRUP): HERBAL SYRUP WILL BE GIVEN 20ML TWICE DAILY FOR 56 DAYS Control Intervention1: TABLET METFORMIN 500MG: TABLET METFORMIN 500MG WILL BE GIVEN TWICE DAILY

Sponsors

NATIONAL RESEARCH INSTITUTE OF UNANI MEDICINE FOR SKIN DISORDERS HYDERABAD
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Participants of PCOS as diagnosed by Rotterdam Criteria Clinical Hyperandrogenism or Biochemical Hyperandrogenism (Raised Testosterone) Evidence of Oligo-anovulation Oligo-amenorrhea Amenorrhea Polycystic Ovarian Morphology (PCOM) on USG or BMI

Exclusion criteria

Exclusion criteria: Patients having congenital uterine abnormalities Patients with history of Hormone Replacement Therapy, or using any other long-term medication Patients with known active systemic diseases Known Cases of Hypothyroidism, severe Hyperprolactinemia Diabetes Mellitus and other immunocompromised disorders Pregnant or Lactating women Participants not willing to give consent and to attend treatment schedule regularly

Design outcomes

Primary

MeasureTime frame
Resumption of Normal, Ovulatory Menstrual Cycles Reduction in Serum Testosterone LevelTimepoint: At baseline and on 2nd, 4th, 6th and 8th weeks

Secondary

MeasureTime frame
Changes in Modified Ferriman Gallwey Hirsutism Score Changes in PCOM on USG Changes in Body Mass Index (BMI) & Waist/Hip Ratio Assessment of Adverse Events at every follow-up visitTimepoint: At baseline & on 8th week

Countries

India

Contacts

Public ContactPROF QAMAR UDDIN

NATIONAL RESEARCH INSTITUTE OF UNANI MEDICINE FOR SKIN DISORDERS, HYDERABAD

qamaruddindr@gmail.com8700027178

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026