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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huang Yishan, doctor; Phone Number: 18810621201; Email: bucmyishan@163.com
• Study Contact Backup: Name: Meng Hua, doctor; Phone Number: 18611457779; Email: menghuade@hotmail.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: nutrition intervention group; Postoperative patients are routinely provided with meal replacement recommendations and dietary plans.	Other: Diet and meal replacements; The dietitian provides recommended meal plans based on body weight, and meal replacements are used postoperatively.
Experimental: Traditional Chinese Medicine combined with nutritional intervention; Chinese herbal treatment is given on the basis of routine dietary intervention.	Other: Diet and meal replacements; The dietitian provides recommended meal plans based on body weight, and meal replacements are used postoperatively.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage change in body weight	Before bariatric surgery, 1 month after surgery, and 3 months after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Traditional Chinese Medicine syndrome score		Before bariatric surgery, 1 month after surgery, and 3 months after surgery.
blood glucose indicators	HbA1c, blood glucose, insulin levels	Before bariatric surgery, 1 month after surgery, and 3 months after surgery.
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.

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: CCMNEWLABS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No