Comparative Effectiveness of Herb-partitioned Moxibustion Plus Lifestyle Modification Treatment for Patients With Simple Obesity: A Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- the clinical effectiveness
研究概览
简要总结
This study is designed as a three-dummy randomised controlled trial to evaluate the efficacy and safety of herb-partitioned moxibustion plus lifestyle modification treatment in patients with simple obesity.
详细描述
This study will be a multicenter, randomized, controlled trial conducted from November, 2018 to November, 2019 that includes 108 participants who have simple obesity and meet the eligibility criteria. The participants will be randomly divided into 3 treatment groups: heat application group, medicated plaster group, or herb-partitioned moxibustion group. Each treatment will last 4 weeks. The primary outcomes will be the clinical effectiveness.The secondary outcome measures include participants'obesity-related indicators, the IWQOL-Lite scale, and the syndrome score of Traditional Chinese Medicine. Adverse events will be recorded during the intervention 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants meeting all of the following criteria will be considered for inclusion:
- •diagnosed as having simple obesity according to the diagnostic criteria;
- •aged between 18 and 45 years old;
- •Waistline: male≥ 95 cm, women≥85 cm;
- •Being able to fully understand and voluntarily sign informed consent.
排除标准
- •Participants will be excluded if they have
- •Presence of endocrine disorders such as: polycystic ovary syndrome; Cushing's syndrome; uncorrected thyroid disease.
- •Presence of diabetes mellitus, or hypertension, or abnormal liver and kidney functions, or mental diseases.
- •Pregnant or lactating state, women who plan to become pregnant within 4 weeks.
- •History of bulimia, anorexia, or any other eating disorders.
- •Use of medications in the past 3 months, such as diet drugs, corticosteroids, antidepressants, which may affect weight or appetite.
- •History of surgical weight loss, postoperative adhesions.
- •History of participating in a clinical study of weight loss or any other therapies to lose weight in the past 3 months.
- •Presence of local skin rupture, allergy and scar constitution.
- •Unable to cooperate with the research caused by other diseases or reasons.
结局指标
主要结局
the clinical effectiveness
时间窗: week 4.
The clinical effectiveness of 4 weeks of (A)Heat application group, (B)Medicated plaster group, and (C)Herb-partitioned moxibustion group for the improvement of simple obesity will be assessed and determined by the clinical evaluation of nimodipine: 1. Healing: The clinical symptoms disappear or almost disappear, and the syndrome score is reduced by ≥85 percent; 2. Significant effect: The clinical symptoms are obviously improved, and the syndrome score is reduced by \<85 percent, but ≥50 percent; 3. Effective: The clinical symptoms have improved, syndrome scores decreased by\<50 percent, but ≥30 percent; 4. Invalid: The clinical symptoms were not improved, even worse, and the syndrome score was reduced by\<30 percent. Integral variation formula(Nimodipine method: \[(pre-treatment score-post-treatment score)/pre-treatment score\]X100 percent.
次要结局
- Body fat percentage(F percent)(week 0, 1, 2, 3, and 4)
- the impact of weight on quality of life (IWQOL)-Lite scale(week 0, 1, 2, 3, and 4)
- Waist circumference(WC)(week 0, 1, 2, 3, and 4)
- hip circumference(HC)(week 0, 1, 2, 3, and 4)
- the syndrome score of Traditional Chinese Medicine(week 0,1,2,3,4.)
- Weight(WG)(week 0, 1, 2, 3, and 4)
- waist-to-hip ratio(waist circumference/hip circumference)(week 0, 1, 2, 3, and 4)
- Visceral fat area(week 0, 1, 2, 3, and 4)
- Body fat Obesity degree(week 0, 1, 2, 3, and 4)
- BMI (weight/(height)(week 0, 1, 2, 3, and 4)