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Not yet recruiting NCT07169292

Effects of Wet-Cupping on Polycystic Ovary Syndrome Patients

No phase Interventional Polycystic Ovarian Syndrome (PCOS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Wet-cupping.
Who it may be relevant to
Registry conditions: Polycystic Ovarian Syndrome (PCOS). Basic parameters: 20 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Saudi Arabia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effects of Wet-Cupping on Polycystic Ovary Syndrome Patients: A Randomized Controlled Trial

Overview

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

Interventions

  • Procedure 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

Primary outcome measures

  • Change in Menstrual Cycle Duration [Time frame: 12 weeks]
  • Change in the Duration of Menstrual Bleeding [Time frame: 12 weeks.]
  • Change in the Volume of Menstrual Bleeding [Time frame: 12 weeks]
  • Change in Dysmenorrhea [Time frame: 12 weeks.]
  • Change in Pregnancy rate (For married participants who are experiencing infertility) [Time frame: 12 weeks]
Secondary outcome measures (11)
  • Change in Insulin Sensitivity [Time frame: 12 weeks.]
  • Change in Metabolic Syndrome Status [Time frame: 12 weeks.]
  • Quality of Life among PCOS Patients [Time frame: 12 weeks.]
  • Change in Ovarian Morphology [Time frame: 12 weeks.]
  • Change in Acne [Time frame: 12 weeks.]
  • Change in Hirsutism [Time frame: 12 weeks.]
  • Change in Androgen Levels (Total Testosterone) [Time frame: 12 weeks.]
  • Change in LH/FSH Ratio [Time frame: 12 weeks.]
  • Change in Follicle-Stimulating Hormone (FSH) Level [Time frame: 12 weeks.]
  • Change in Luteinizing Hormone (LH) Level [Time frame: 12 weeks.]
  • Number of Participants Experiencing Adverse Events Related to Wet Cupping Therapy [Time frame: 12 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Saudi Arabia · 1 center
  • King Abdullah bin Abdulaziz University Hospital — Riyadh

Identifiers

NCT: NCT07169292 · 250094

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗