Combining Chinese Medicine and Nutrition to Enhance Weight Loss After Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Percentage change in body weight
研究概览
简要总结
This study aims to investigate the effects of Chinese herbal granule preparations on improving gastrointestinal symptoms in patients after bariatric surgery. It seeks to establish a novel treatment model that combines bariatric surgery with traditional Chinese medicine, providing clinical practice with additional evidence-based medical support.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≥ 27.5 kg/m²;
- •Undergoing metabolic bariatric surgery;
- •Traditional Chinese Medicine syndrome differentiation classified as Spleen Deficiency and Excess Dampness syndrome.
排除标准
- •Contraindications for metabolic bariatric surgery;
- •Type 1 diabetes;
- •Complicated by other significant systemic diseases, such as severe liver and kidney diseases, malignant tumors, psychiatric disorders, etc;
- •Concurrent use of other medications or treatments that may affect body weight, such as metformin, semaglutide, endoscopic interventions, etc;
- •Pregnant or lactating women.
研究组 & 干预措施
nutrition intervention group
Postoperative patients are routinely provided with meal replacement recommendations and dietary plans.
干预措施: Diet and meal replacements (Other)
Traditional Chinese Medicine combined with nutritional intervention
Chinese herbal treatment is given on the basis of routine dietary intervention.
干预措施: Spleen Invigorating and Weight Reducing Decoction (Drug)
Traditional Chinese Medicine combined with nutritional intervention
Chinese herbal treatment is given on the basis of routine dietary intervention.
干预措施: Diet and meal replacements (Other)
结局指标
主要结局
Percentage change in body weight
时间窗: Before bariatric surgery, 1 month after surgery, and 3 months after surgery.
次要结局
- blood glucose indicators(Before bariatric surgery, 1 month after surgery, and 3 months after surgery.)
- blood lipid profile(Before bariatric surgery, 1 month after surgery, and 3 months after surgery.)
- Traditional Chinese Medicine syndrome score(Before bariatric surgery, 1 month after surgery, and 3 months after surgery.)
研究者
Hua Meng
Director of the General Surgery Department & Obesity and Metabolic Disease Center of China-Japan Friendship Hospital
China-Japan Friendship Hospital