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A Clinical study to see the effect of a Unani drug in the patients of Polycystic Ovarian Syndrome.

A randomised controlled clinical study of a Unani formulation in the management of Polycystic Ovarian Syndrome - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057869
Enrollment
40
Registered
2023-09-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Health Condition 1: N74- Female pelvic inflammatory disorders in diseases classified elsewhere

Interventions

Intervention1: A Unani formulation in capsule form: Unani drug in 500mg capsule form to be taken orally, 1 capsule daily for 3 months Control Intervention1: Group B will be treated according to modern

Sponsors

SUMER Jamia Hamdard
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosis of PCOS according to Rotterdam’s criteria fulfilling any two of the following Menstrual Irregularities or oligo/anovulation Hyperandrogenism (clinically or biochemically) Polycystic appearance on Ultrasound. Patient with no previous history of taking OCP (Oral Contraceptive Pills) or HRT (Hormonal Replacement Therapy) within 3 months. Willingness to sign the informed consent, follow the protocol and participate in the clinical study voluntarily.

Exclusion criteria

Exclusion criteria: 1. Patients with a) Cardiovascular disease or elevated blood pressure above 160/90mmhg. b) Diabetes type 1 or 2 c) Kidney, liver or heart disease. d) Thyroid disease. e) Alchoholism f) Hormonal contraceptives. g) Irregular menstrual bleeding other than PCOS. h)Uterine synachiae, Terine fibroid, Endometriosis, Cervical carcinoma. i) Severe drug reaction. 2. Pregnant and Lactating women. 3. Unwilling to participate in the study.

Design outcomes

Primary

MeasureTime frame
1. Menstrual cycle 2. Ultrasound PelvisTimepoint: 1. Cycle duration flow 2. number & size of cysts

Secondary

MeasureTime frame
1.Reduction in testosterone level. 2.Change in luetenizing hormone. 3. Change in Ratio of LH FSH. 4. Cahnge in Ferryman galloway score. 5. Change in Insulin levels. 6. Improvement in Lipid profile.Timepoint: All above points are seen from baseline to 3 months.

Countries

India

Contacts

Public ContactDr. Azhar Jabin

Jamia Hamdard

ajabin@jamiahamdard.ac.in9899315252

Outcome results

None listed

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