Effect of Unani Medicine for the Management of Anomalies Associated With Polycystic Ovarian Syndrome

Hamdard University

Status and phase: Enrolling; Phase 1

Conditions: Comparative Study

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT06199544

HamdardUniversity

Details and patient eligibility

About

Currently available medications for PCOS are symptom(s) oriented but have limitations because of its complex pathophysiology. The most preferred drug against PCOS is metformin which act as an insulin sensitizer to improve insulin-glucose metabolism and anovulatory cycles in PCOS. However, its use is associated with various side effects such as bloating, diarrhea and nausea. Thus, it is imperative to explore various other alternatives to combat this gynecological problem.

Full description

Polycystic ovarian syndrome (PCOS) is a common endocrine disorder in reproductive age women, with a prevalence between 5%-15%. Currently, sedentary lifestyle, excessive intake of junk food and increasing prevalence of obesity has been associated with rise in the incidence of PCOS.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria No complications record of reproductive system, 4) PCOS diagnosed using Rotterdam criteria fulfilling any two of the following: (i) Menstrual irregularity or oligo-/anovulation, (ii) Hyperandrogenism (clinically and/or biochemically), (iii) Polycystic appearance on ultrasound

Exclusion criteria

1. Patients with severe adverse drug reactions, 2) Record of cardiovascular, diabetes, hepatic and neoplastic disorders or other concurrent medical illnesses, 3) Hormonal contraceptive used within 6 months, or anti-obesity drugs within 3 months of the study, 4) Irregular menstrual bleeding other than PCOS and 5) Positive pregnancy test.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Control group

Experimental group

Description:

metformin 500 mg twice a day

Treatment:

Drug: Metformin

Picolin group

Experimental group

Description:

Picolin 500mg thrice a day

Treatment:

Drug: Metformin

Rasoline

Experimental group

Description:

Rasoline 500mg thrice a day

Treatment:

Drug: Metformin