Effects of Wet-Cupping on Polycystic Ovary Syndrome Patients

NCT ID: NCT07169292

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-12-31

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

Conditions

Polycystic Ovarian Syndrome (PCOS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hijama Group

Group Type: EXPERIMENTAL

Wet-cupping

Intervention Type: PROCEDURE

The intervention consists of three sessions of wet cupping therapy (Hijama), administered once every month over three consecutive months. This study's protocol is distinguished by its standardized, medically supervised approach, designed to align traditional Hijama practices with modern clinical trial standards.

Key features that distinguish this intervention include:

Standardized Procedure: The Hijama protocol follows a detailed, consistent method including suction, superficial skin incisions, and reapplication of suction, followed by honey dressing. All sessions use disposable, single-use instruments and follow strict infection control measures.

Timing Based on Prophetic Recommendation: Cupping is performed on the 17th, 19th, or 21st day of the Islamic lunar month, which is rooted in Islamic tradition and rarely standardized in scientific studies.

Certified Practitioner and Setting: Procedures are conducted by a licensed Hijama practitioner with

Control Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Wet-cupping

The intervention consists of three sessions of wet cupping therapy (Hijama), administered once every month over three consecutive months. This study's protocol is distinguished by its standardized, medically supervised approach, designed to align traditional Hijama practices with modern clinical trial standards.

Key features that distinguish this intervention include:

Standardized Procedure: The Hijama protocol follows a detailed, consistent method including suction, superficial skin incisions, and reapplication of suction, followed by honey dressing. All sessions use disposable, single-use instruments and follow strict infection control measures.

Timing Based on Prophetic Recommendation: Cupping is performed on the 17th, 19th, or 21st day of the Islamic lunar month, which is rooted in Islamic tradition and rarely standardized in scientific studies.

Certified Practitioner and Setting: Procedures are conducted by a licensed Hijama practitioner with

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Female participants.
• Aged 20 to 40 years.
• Diagnosed with Polycystic Ovary Syndrome (PCOS) according to the Rotterdam criteria.
• Willing to participate in the study and provide informed consent.
• Not using any of the following in the last month: (Hormonal medications for menstruation, Herbal menstrual remedies or Metformin).

Exclusion Criteria

• Known diagnosis of uncontrolled thyroid dysfunction.
• Diagnosis of diabetes mellitus.
• Elevated FSH levels above 20 mIU/mL.
• Hyperprolactinemia with serum levels above 1000 mIU/L.
• Pregnant or lactating women.
• Known coagulation disorders.
• Anemia with hemoglobin levels less than 10 g/dL.
• History of undergoing dry cupping, wet cupping, or acupuncture in the past 6 months.
• History of surgical removal of both ovaries or the uterus.
• Other causes of hyperandrogenism, including:
• Late-onset non-classic 21-hydroxylase deficiency (excluded clinically; lab investigation if clinically indicated).
• Ovarian androgen-secreting tumors.
• Use of anabolic or androgenic drugs.
• Cushing's syndrome.
• Hypothalamic or pituitary disorders causing amenorrhea.
• Primary ovarian insufficiency.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Princess Nourah Bint Abdulrahman University

OTHER

Sponsor Role: lead

Responsible Party

Nouran Abdullah Aleyeidi

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

King Abdullah bin Abdulaziz University Hospital

Riyadh, Central, Saudi Arabia

Countries

Saudi Arabia

Central Contacts

Nouran Aleyeidi

Role: CONTACT

naaleyeidi@pnu.edu.sa

+966504304577

Facility Contacts

Nouran Aleyeidi

Role: primary

naaleyeidi@pnu.edu.sa

0504304577

Other Identifiers

250094

Identifier Type: -

Identifier Source: org_study_id