Combining Chinese Medicine and Nutrition to Enhance Weight Loss After Bariatric Surgery

Not Applicable

Recruiting

• Conditions: Traditional Chinese Medicine Treatment; Weight Change
• Interventions: Drug: Spleen Invigorating and Weight Reducing Decoction; Other: Diet and meal replacements

• Registration Number: NCT06419764
• Lead Sponsor: China-Japan Friendship Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-14
• Last Update Submitted: 2024-05-14
• Study First Posted: 2024-05-17
• Last Update Posted: 2024-05-17
• Primary Completion: 2024-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Chinese Medicine combined with nutritional intervention	Diet and meal replacements	Chinese herbal treatment is given on the basis of routine dietary intervention.
nutrition intervention group	Diet and meal replacements	Postoperative patients are routinely provided with meal replacement recommendations and dietary plans.
Traditional Chinese Medicine combined with nutritional intervention	Spleen Invigorating and Weight Reducing Decoction	Chinese herbal treatment is given on the basis of routine dietary intervention.

Primary Outcome Measures

Name	Time	Method
Percentage change in body weight	Before bariatric surgery, 1 month after surgery, and 3 months after surgery.

Secondary Outcome Measures

Name	Time	Method
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
blood glucose indicators	Before bariatric surgery, 1 month after surgery, and 3 months after surgery.	HbA1c, blood glucose, insulin levels
Traditional Chinese Medicine syndrome score	Before bariatric surgery, 1 month after surgery, and 3 months after surgery.

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, China