Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
Study NCT ID:
NCT07169292
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-11
First Post:
2025-08-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Wet-Cupping on Polycystic Ovary Syndrome Patients
Sponsor:
Princess Nourah Bint Abdulrahman University
Organization:
Study Overview
Official Title:
Effects of Wet-Cupping on Polycystic Ovary Syndrome Patients: A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate whether wet cupping therapy (Hijama) can improve reproductive and metabolic outcomes in women diagnosed with Polycystic Ovary Syndrome (PCOS). This study will be conducted among female participants aged 20-40 years who have been diagnosed with PCOS according to the Rotterdam criteria.
The main questions it aims to answer are:
Can wet cupping therapy regulate menstrual cycles in women with PCOS?
Can it increase the pregnancy rate in married participants with PCOS-related infertility?
Researchers will compare outcomes between a wet cupping group and a control group to determine whether Hijama has significant effects on reproductive, hormonal, and metabolic markers.
Participants will:
Undergo screening and eligibility evaluation using a checklist
Be randomized into either the wet cupping (intervention) or control group
Receive lifestyle counseling (diet and physical activity)
For the intervention group:
Receive one Hijama session performed by a certified practitioner
Undergo follow-up at 4 and 12 weeks for clinical, hormonal, and ultrasound assessments
For all participants:
Complete laboratory tests, ultrasound scans, and questionnaires on PCOS symptoms and quality of life
Report any side effects during and after the study period
The main questions it aims to answer are:
Can wet cupping therapy regulate menstrual cycles in women with PCOS?
Can it increase the pregnancy rate in married participants with PCOS-related infertility?
Researchers will compare outcomes between a wet cupping group and a control group to determine whether Hijama has significant effects on reproductive, hormonal, and metabolic markers.
Participants will:
Undergo screening and eligibility evaluation using a checklist
Be randomized into either the wet cupping (intervention) or control group
Receive lifestyle counseling (diet and physical activity)
For the intervention group:
Receive one Hijama session performed by a certified practitioner
Undergo follow-up at 4 and 12 weeks for clinical, hormonal, and ultrasound assessments
For all participants:
Complete laboratory tests, ultrasound scans, and questionnaires on PCOS symptoms and quality of life
Report any side effects during and after the study period
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: