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

Weight Change Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06419764
• Other study ID #: CCMNEWLABS
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: China-Japan Friendship Hospital
• Contact: Huang Yishan, doctor
• Phone: 18810621201
• Email: bucmyishan[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Weight Change
• Weight Loss

Intervention

Drug:
• Spleen 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.

Other:
• Diet and meal replacements
The dietitian provides recommended meal plans based on body weight, and meal replacements are used postoperatively.

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in body weight		Before bariatric surgery, 1 month after surgery, and 3 months after surgery.
Secondary	Traditional Chinese Medicine syndrome score		Before bariatric surgery, 1 month after surgery, and 3 months after surgery.
Secondary	blood glucose indicators	HbA1c, blood glucose, insulin levels	Before bariatric surgery, 1 month after surgery, and 3 months after surgery.
Secondary	blood lipid profile	total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol	Before bariatric surgery, 1 month after surgery, and 3 months after surgery.