Effect of Auricular Acupressure on Overweight/Obese Adolescent and Young Women With Polycystic Ovary Syndrome.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Body mass index (BMI): BMI change at 3 months.
研究概览
简要总结
The purpose of this trial is to investigate the effect and safety of auricular acupressure on adolescent and young women with PCOS. Subjects will be randomly assigned in to two arms: Auricular acupressure arm and placebo auricular acupressure, both arms will be treated for three months. Body mass index, oral glucose tolerance test, hormonal profile and metabolic profile will be determined.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged between 12 and 25 years.
- •Diagnosis of PCOS according to the modified Rotterdam criteria.
- •2 years after menarche.
- •Body mass index (BMI) equal to or greater than 23 kg/m*m.
排除标准
- •Administration of other medications known to affect reproductive function or metabolism within the past three months, including oral contraceptives, Gonadotropin-releasing hormone (GnRH) agonists and antagonists, anti androgens, gonadotropins, anti-obesity drugs, Chinese herbal medicines, anti diabetic drugs such as metformin and thiazolidinediones, somatostatin, diazoxide, and calcium channel blockers.
- •Patients with other endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected Cushing's syndrome.
- •Patients with known severe organ dysfunction or mental illness.
研究组 & 干预措施
Placebo auricular acupressure
The magnetic beads will be taped to the three pressing points:Tonsil, eye and elbow.
干预措施: Placebo auricular acupressure (Other)
Auricular acupressure
The magnetic beads will be taped to the seven pressing points: Hunger point, Ovary, Uterus, Endocrine point, liver, kidney and spleen.
干预措施: Auricular acupressure (Other)
结局指标
主要结局
Body mass index (BMI): BMI change at 3 months.
时间窗: 3 month
次要结局
- Oral glucose tolerance test (OGTT)(3 month)
- Luteinizing hormone (LH)(3 month)
- Cholesterol(3 month)
- Triglycerides (TG)(3 month)
- Waist/hip ratio(3 month)
- Testosterone (T)(3 month)
- Dehydroepiandrosterone sulfate (DHEAS).(3 month)
- Follicle stimulating hormone (FSH)(3 month)
- Ferriman-Gallwey score(3 month)
- Sex hormone-binding globulin (SHBG)(3 month)
研究者
Yan Li
Associate chief physician
Heilongjiang University of Chinese Medicine