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

December 29, 2023 updated by: Leena Hameed, Hamdard University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Recruiting
        • Shifa ul mulk memorial hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control group
metformin 500 mg twice a day
Drug: Metformin
Comparing the effect of drugs on symptoms of PCOS
Other Names:
  • Picolin
  • Rasoline
Experimental: Picolin group
Picolin 500mg thrice a day
Drug: Metformin
Comparing the effect of drugs on symptoms of PCOS
Other Names:
  • Picolin
  • Rasoline
Experimental: Rasoline
Rasoline 500mg thrice a day
Drug: Metformin
Comparing the effect of drugs on symptoms of PCOS
Other Names:
  • Picolin
  • Rasoline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in the menstrual regularity of the patient
Time Frame: 1 year
The lengths and duration of menstrual cycle of patients will be measured
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamdard University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 29, 2023

First Submitted That Met QC Criteria

December 29, 2023

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

December 29, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HamdardUniversity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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