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Trial Title:
Effect of Unani Medicine for the Management of Anomalies Associated With Polycystic Ovarian Syndrome
NCT ID:
NCT06199544
Condition:
Comparative Study
Conditions: Official terms:
Polycystic Ovary Syndrome
Metformin
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomised controlled trial
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Metformin
Description:
Comparing the effect of drugs on symptoms of PCOS
Arm group label:
Control group
Arm group label:
Picolin group
Arm group label:
Rasoline
Other name:
Picolin
Other name:
Rasoline
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.
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.
Criteria for eligibility:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
38 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shifa ul mulk memorial hospital
Address:
City:
Karachi
Country:
Pakistan
Status:
Recruiting
Contact:
Last name:
Noman Khan, PhD
Phone:
03453161306
Email:
nomankhan007@hotmail.com
Start date:
October 1, 2022
Completion date:
December 1, 2024
Lead sponsor:
Agency:
Hamdard University
Agency class:
Other
Source:
Hamdard University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06199544
