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Набор скоро начнётся NCT07169292

Effects of Wet-Cupping on Polycystic Ovary Syndrome Patients

Без фазы С лечением Polycystic Ovarian Syndrome (PCOS)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Wet-cupping.
Кому может быть актуально
Состояния в реестре: Polycystic Ovarian Syndrome (PCOS). Базовые параметры: 20 лет — 40 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Саудовская Аравия
Следующий шаг
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Официальное название

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

Обзор

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

Вмешательства

  • Процедура 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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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).

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Саудовская Аравия · 1 центр
  • King Abdullah bin Abdulaziz University Hospital — Riyadh

Идентификаторы

NCT: NCT07169292 · 250094

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗