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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Comparative Study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

metformin 500 mg twice a day

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Comparing the effect of drugs on symptoms of PCOS

Picolin group

Picolin 500mg thrice a day

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Comparing the effect of drugs on symptoms of PCOS

Rasoline

Rasoline 500mg thrice a day

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Comparing the effect of drugs on symptoms of PCOS

Interventions

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Metformin

Comparing the effect of drugs on symptoms of PCOS

Intervention Type DRUG

Other Intervention Names

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Picolin Rasoline

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No