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

Comparative Study Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06199544
• Other study ID #: HamdardUniversity
• Status: Recruiting
• Phase: Phase 1
• Start date: October 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: December 2023
• Source: Hamdard University
• Contact: Leena Hameed, M.Phil.
• Phone: 00923333037145
• Email: Leena.hameed[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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.

Related Conditions & MeSH terms

• Comparative Study
• Polycystic Ovary Syndrome

Intervention

Drug:
• Metformin
Comparing the effect of drugs on symptoms of PCOS

Locations

Country	Name	City	State
Pakistan	Shifa ul mulk memorial hospital	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Hamdard University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in the menstrual regularity of the patient	The lengths and duration of menstrual cycle of patients will be measured	1 year