Effects of Wet-Cupping on Polycystic Ovary Syndrome Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Menstrual Cycle Duration
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Change in Menstrual Cycle Duration
时间窗: 12 weeks
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.
Change in the Duration of Menstrual Bleeding
时间窗: 12 weeks.
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.
Change in the Volume of Menstrual Bleeding
时间窗: 12 weeks
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.
Change in Dysmenorrhea
时间窗: 12 weeks.
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.
Change in Pregnancy rate (For married participants who are experiencing infertility)
时间窗: 12 weeks
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.
次要结局
- Change in Insulin Sensitivity(12 weeks.)
- Change in Metabolic Syndrome Status(12 weeks.)
- Quality of Life among PCOS Patients(12 weeks.)
- Change in Ovarian Morphology(12 weeks.)
- Change in Acne(12 weeks.)
- Change in Hirsutism(12 weeks.)
- Change in Androgen Levels (Total Testosterone)(12 weeks.)
- Change in LH/FSH Ratio(12 weeks.)
- Change in Follicle-Stimulating Hormone (FSH) Level(12 weeks.)
- Change in Luteinizing Hormone (LH) Level(12 weeks.)
- Number of Participants Experiencing Adverse Events Related to Wet Cupping Therapy(12 weeks)
研究者
Nouran Abdullah Aleyeidi
Dr.
Princess Nourah Bint Abdulrahman University