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Effects of Wet-Cupping on Polycystic Ovary Syndrome Patients

P

Princess Nourah Bint Abdulrahman University

Status

Not yet enrolling

Conditions

Polycystic Ovarian Syndrome (PCOS)

Treatments

Procedure: Wet-cupping

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

60 estimated patients

Sex

Female

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Hijama Group
Experimental group
Treatment:
Procedure: Wet-cupping
Control Group
No Intervention group

Trial contacts and locations

1

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Central trial contact

Nouran Aleyeidi

Data sourced from clinicaltrials.gov

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