Evaluation of the Clinical Efficacy of Moxibustion With Regulating Yin and Yang in the Treatment of Menopausal Obesity
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Waist circumference
研究概览
简要总结
This study is designed as a two-dummy randomized controlled trial to evaluate the safety and superiority of Yin and Yang regulating moxibustion in the treatment of menopausal obese patients.
详细描述
The study will be a multicenter, randomized, controlled trial, conducted from January 2021 to December 2022, including 216 menopausal obese patients who meet the inclusion criteria. The subjects will be randomly divided into 2 treatment groups: Yin and Yang regulating moxibustion group and mild moxibustion group. Each group of treatment will last for 12 weeks, with a follow-up period of 12 weeks. The main outcome indicator is waist circumference. The secondary outcome indicators include subjects related to obesity, TCM clinical syndrome score and modified Kupperman score, weight impact on quality of life scale (IWQOL-Lite), quality of life assessment health survey summary (SF-36). During the intervention period, adverse events will be recorded.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the diagnostic criteria for menopausal syndrome and obesity;
- •Patients with BMI≥25 and waist circumference≥80cm;
- •Female patients between 40-60 years old;
- •Have not taken any hormone drugs or weight loss related drugs in the past 3 months;
- •Sign the informed consent and voluntarily accept the intervention methods of this project.
排除标准
- •Unexplained vaginal bleeding, or unnatural menopause;
- •Have used hormone replacement therapy or other drugs related to this disease in the past 3 months;
- •Combined with serious organic diseases, endocrine diseases, heart, liver and kidney, and respiratory diseases;
- •Secondary obesity caused by hypothalamic lesions, hypothyroidism, glucocorticoid therapy, etc.;
- •Combined with organic uterine diseases, such as polycystic ovary syndrome, malignant tumors, severe cervical erosion, after total hysterectomy, etc.;
- •There are contraindications to moxibustion, such as moxibustion intolerance, skin allergies, scars, and other serious skin diseases;
- •Poor compliance and unable to adhere to treatment.
结局指标
主要结局
Waist circumference
时间窗: Week 0, 4, 8, 12, 18and24.
The change in waist circumference compared to the baseline.
次要结局
- Body fat percentage(F percent)(Week 0, 4, 8, 12, 18and24.)
- Waist-to-hip ratio(waist circumference/hip circumference)(Week 0, 4, 8, 12, 18and24.)
- Modified Kupperman score(Week 0, 12and24.)
- Blood lipids: cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-C), high-density lipoprotein (HDL-C).(Week 0 and 12.)
- Estrogen: estradiol (E2), serum follicle-forming hormone (FSH).(Week 0 and12.)
- BMI(weight/height²)(Week 0, 4, 8, 12, 18and24.)
- Weight(WG)(Week 0, 4, 8, 12, 18and24.)
- The impact of weight on quality of life (IWQOL)-Lite scale(Week 0, 12and24.)
- The MOS Item Short from Health Survey（SF-36).(Week 0, 12and24.)
- Hip circumference(HC)(Week 0, 4, 8, 12, 18and24.)
- The syndrome score of Traditional Chinese Medicine(Week 0, 12and24.)