Effects of Wet-Cupping on Polycystic Ovary Syndrome Patients

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• Polycystic Ovary Syndrome 956

Polycystic Ovary Syndrome

956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.

This study's planned enrollment of 60 is below the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.

Lead sponsor

Princess Nourah Bint Abdulrahman University is the lead sponsor of 31 studies on the registry; 4 are open to participants now.

Study arms

• Experimental
  Hijama Group

  Procedure: Wet-cupping

• No intervention
  Control Group

Interventions

• ProcedureWet-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

Primary outcomes

1. Change in Menstrual Cycle Duration

   This outcome refers to the change in the length of the entire menstrual cycle, measured in days, defined as the time from the first day of one menstrual period to the first day of the next. This measure reflects the regularity and timing of menstrual cycles, which are commonly disrupted in patients with Polycystic Ovary Syndrome (PCOS). Data will be collected through a structured self-report questionnaire administered at baseline and again at 12 weeks post-intervention. The difference in reported cycle length will be analyzed to evaluate the effect of wet cupping (Hijama) therapy on menstrual cycle regulation. This outcome aims to provide insight into the potential therapeutic impact of the intervention on menstrual irregularities, a hallmark clinical feature of PCOS.

   Time frame: 12 weeks

2. Change in the Duration of Menstrual Bleeding

   This outcome refers to the change in the number of days of menstrual bleeding experienced by each participant, measured from the first day of visible menstrual blood flow to the last day of bleeding (excluding spotting). Data will be collected using a structured questionnaire administered at baseline and 12 weeks after the intervention. The reported number of bleeding days at follow-up will be compared to baseline values to assess the impact of the intervention. This outcome is intended to capture clinically relevant changes in the menstrual pattern of participants with PCOS following the wet cupping therapy. It will also contribute to understanding the potential therapeutic benefits of Hijama on menstrual regulation.

   Time frame: 12 weeks.

3. Change in the Volume of Menstrual Bleeding

   This outcome refers to the change in the volume of menstrual bleeding, measured by the maximum number of sanitary pads used per day during the heaviest day of menstruation. This is a commonly used proxy to estimate menstrual blood loss in clinical studies. Data will be collected using a questionnaire at baseline and again at 12 weeks after the intervention. Participants will be asked to report the number of full-sized pads used per day at their heaviest bleeding before and after the study period. The goal of this outcome is to assess whether wet cupping (Hijama) has a regulatory or therapeutic effect on abnormal uterine bleeding, which is a frequent symptom in women with PCOS.

   Time frame: 12 weeks

4. Change in Dysmenorrhea

   This outcome refers to the change in the severity of dysmenorrhea (menstrual pain) among participants, assessed before and after the intervention. Dysmenorrhea severity will be measured using a Numerical Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will report the maximum pain intensity experienced during menstruation over the past three cycles. Data will be collected using a structured questionnaire at baseline and again 12 weeks after the intervention. The purpose of this outcome is to evaluate whether wet cupping therapy (Hijama) can effectively reduce menstrual pain, which is a commonly reported symptom in PCOS patients and a contributor to reduced quality of life.

   Time frame: 12 weeks.

5. Change in Pregnancy rate (For married participants who are experiencing infertility)

   This outcome refers to the proportion of married PCOS participants with a history of infertility who achieve pregnancy during the study period. Pregnancy will be confirmed by a positive serum β-hCG test following a missed menstrual cycle and/or by clinical confirmation via ultrasound at a healthcare facility. Data will be collected through follow-up questionnaires and medical record review at baseline and at 12 weeks post-intervention. The goal is to assess whether wet cupping (Hijama) has a potential role in enhancing fertility in women with PCOS-related infertility. Any pregnancies that occur during the study will be documented and analyzed as a binary outcome (pregnant vs. not pregnant), with comparison between the intervention and control groups.

   Time frame: 12 weeks

Secondary outcomes

1. Change in Insulin Sensitivity

   Definition: This outcome assesses the change in insulin sensitivity in participants from baseline to 12 weeks after the intervention. Measurement Method: Fasting Insulin and Fasting Glucose will be measured at baseline and at the end of the study. The Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) will be calculated using the formula:HOMA-IR= Fasting Insulin (μU/mL) × Fasting Glucose (mg/dL)/405 Lower HOMA-IR values indicate improved insulin sensitivity. Timepoints: At baseline then after 12 weeks.

   Time frame: 12 weeks.

2. Change in Metabolic Syndrome Status

   Definition: This outcome will assess any changes in participants' metabolic syndrome status from baseline to 12 weeks post-intervention, based on the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) criteria. Criteria include the presence of at least three of the following five: Waist circumference \>88 cm in females, Triglycerides ≥150 mg/dL, HDL cholesterol \<50 mg/dL in females, Blood pressure ≥130/85 mmHg or use of antihypertensive medication, and Fasting plasma glucose ≥100 mg/dL or use of anti-diabetic medications. Measurement Method: Clinical assessments (e.g., blood pressure, waist circumference). Laboratory tests (e.g., fasting glucose, lipid profile). Timepoints: At baseline then after 12 weeks.

   Time frame: 12 weeks.

3. Quality of Life among PCOS Patients

   Quality of life will be assessed using a validated PCOS-specific tool, the PCOSQ (Polycystic Ovary Syndrome Questionnaire), which measures health-related quality of life across relevant domains including: Emotional well-being, Body hair and appearance, Infertility concerns, Menstrual problems, and Weight-related issues. Participants will complete the questionnaire at baseline and again 12 weeks after the intervention. Each item will be rated on a Likert scale, and domain-specific as well as overall scores will be calculated. Higher scores will indicate better quality of life. Changes from baseline will be compared between the intervention and control groups.

   Time frame: 12 weeks.

4. Change in Ovarian Morphology

   This outcome will evaluate the structural changes in ovarian morphology using pelvic ultrasound imaging, performed at baseline and 12 weeks post-intervention. Measurements will include: Ovarian volume (in cm³) for each ovary, calculated using the ellipsoid formula (length × width × thickness × 0.523), Number of antral follicles per ovary (2-9 mm in diameter) and Presence of peripheral "string of pearls" follicle pattern or increased stromal echogenicity. Ultrasounds will be conducted by certified radiologists blinded to group assignment to reduce assessment bias. Improvement will be indicated by a reduction in the number of follicles, normalization of ovarian volume, or resolution of typical PCOS-specific morphological features.

   Time frame: 12 weeks.

5. Change in Acne

   This outcome measures the change in acne severity using a standardized acne grading scale such as the Global Acne Grading System (GAGS). Acne will be evaluated at baseline and 12 weeks post-intervention, considering factors like lesion type (comedones, papules, pustules, nodules), anatomical location, and number of lesions. Scores will be categorized into mild, moderate, severe, or very severe acne. A reduction in GAGS score following the intervention will indicate improvement in acne symptoms, likely reflecting decreased androgen activity in the skin.

   Time frame: 12 weeks.

6. Change in Hirsutism

   This outcome assesses the change in hirsutism severity using the modified Ferriman-Gallwey (mFG) score, a validated clinical tool that evaluates terminal hair growth in nine androgen-sensitive areas of the body. Each area is scored from 0 (no hair) to 4 (extensive hair growth), with a total score range of 0 to 36. Assessments will be performed at baseline and at 12 weeks post-intervention by trained female healthcare providers. A decrease in the mFG score after Hijama therapy will indicate a reduction in androgen-related clinical manifestations.

   Time frame: 12 weeks.

7. Change in Androgen Levels (Total Testosterone)

   This outcome evaluates changes in serum total testosterone concentrations, a key marker of hyperandrogenism in PCOS patients. Blood samples will be collected at baseline and 12 weeks after the intervention, and testosterone levels will be measured using standardized immunoassay methods. Results will be expressed in ng/dL. The outcome will help determine whether wet cupping (Hijama) contributes to reducing elevated androgen levels, which are associated with clinical manifestations such as hirsutism, acne, and ovulatory dysfunction. This measurement serves as a critical indicator of the intervention's effect on the hormonal imbalance characteristic of PCOS.

   Time frame: 12 weeks.

8. Change in LH/FSH Ratio

   This outcome assesses changes in the LH to FSH ratio, a key hormonal marker often altered in PCOS. The ratio will be calculated from measured LH and FSH values at baseline and 12 weeks post-intervention. The LH/FSH ratio provides a more sensitive indicator of hormonal imbalance and is important in understanding the effect of Hijama therapy on reproductive endocrinology.

   Time frame: 12 weeks.

9. Change in Follicle-Stimulating Hormone (FSH) Level

   This outcome measures the variation in serum FSH concentrations before and after the intervention. Blood samples will be collected at baseline and at 12 weeks post-intervention. Laboratory analysis will use standard immunoassay techniques, and values will be expressed in IU/L. The results will help assess the potential endocrine-modulating effects of wet cupping on FSH levels in women with PCOS.

   Time frame: 12 weeks.

10. Change in Luteinizing Hormone (LH) Level

    This outcome refers to the variation in serum LH concentration measured before and after the intervention. Blood samples will be collected from participants at baseline and again at 12 weeks post-intervention. Laboratory analysis will be conducted using standardized immunoassay techniques at the hospital's certified clinical laboratory. LH levels will be expressed in IU/L, and changes will be evaluated as continuous variables. The purpose of this outcome is to assess the impact of wet cupping (Hijama) on hormonal regulation in women diagnosed with PCOS. Results will be compared between the intervention and control groups using appropriate statistical tests (e.g., t-test), and a p-value \< 0.05 will be considered statistically significant.

    Time frame: 12 weeks.

11. Number of Participants Experiencing Adverse Events Related to Wet Cupping Therapy

    Detailed Description: This outcome will assess the frequency and types of adverse events (AEs) observed in participants receiving wet cupping (Hijama). Events will be monitored both immediately after each cupping session and again at 4 weeks post-intervention. Assessment Time Points: Immediate (within 1 hour post-session) Delayed (at 4-week follow-up) Assessment Method: A structured adverse event checklist will be completed by the research team after each Hijama session and during follow-up. Participants will also self-report any symptoms. Types of Adverse Events to Be Monitored: 1. Immediate Adverse Events (Post-Hijama) * Syncope (fainting) * Dizziness * Nausea * Hypotension * Bleeding Headache * Localized pain * Bruising * Bullae (blister-like lesions). 2. Delayed Adverse Events (4 Weeks Post-Hijama) * Wound infection * Persistent scars * Hyperpigmentation

    Time frame: 12 weeks

Individual participant data

Plan to share: No