Traditional Chinese Medicine Treatment, Weight Change
Conditions
Brief summary
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.
Interventions
DRUGSpleen Invigorating and Weight Reducing Decoction
Composition: Raw Astragalus (Huang Qi) 5g, Cang Zhu 5g, Fructus Aurantii Immaturus (Zhi Shi) 3g, Prepared Rhubarb (Shu Jun) 3g, Red Peony Root (Chi Shao Yao) 3g, Crataegus (Shan Zha) 3g, Tribulus (Bai Jie Li) 2g, Cimicifuga (Sheng Ma) 1g. Granule form, for oral administration. Take 1 dose daily (2 bags, once in the morning and once in the evening, dissolved in water), for a course of 1 month.
OTHERDiet and meal replacements
The dietitian provides recommended meal plans based on body weight, and meal replacements are used postoperatively.
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. BMI ≥ 27.5 kg/m²; 2. Undergoing metabolic bariatric surgery; 3. Traditional Chinese Medicine syndrome differentiation classified as Spleen Deficiency and Excess Dampness syndrome.
Exclusion criteria
1. Contraindications for metabolic bariatric surgery; 2. Type 1 diabetes; 3. Complicated by other significant systemic diseases, such as severe liver and kidney diseases, malignant tumors, psychiatric disorders, etc; 4. Concurrent use of other medications or treatments that may affect body weight, such as metformin, semaglutide, endoscopic interventions, etc; 5. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in body weight | Before bariatric surgery, 1 month after surgery, and 3 months after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Traditional Chinese Medicine syndrome score | Before bariatric surgery, 1 month after surgery, and 3 months after surgery. | — |
| blood glucose indicators | Before bariatric surgery, 1 month after surgery, and 3 months after surgery. | HbA1c, blood glucose, insulin levels |
| blood lipid profile | Before bariatric surgery, 1 month after surgery, and 3 months after surgery. | total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol |
Countries
China
Contacts
Primary ContactHuang Yishan, doctor
Backup ContactMeng Hua, doctor
Outcome results
None listed