## Protocol Section
### Identification Module
**NCT ID:** NCT06419764

**Brief Title:** Combining Chinese Medicine and Nutrition to Enhance Weight Loss After Bariatric Surgery

**Official Title:** Combining Chinese Medicine and Nutrition to Enhance Weight Loss After Bariatric Surgery

#### Organization Study ID Info
**ID:** CCMNEWLABS
#### Organization
**Class:** OTHER
**Full Name:** China-Japan Friendship Hospital
### Status Module
#### Completion Date
**Date:** 2025-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-02-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** China-Japan Friendship Hospital

#### Responsible Party

**Investigator Affiliation:** China-Japan Friendship Hospital

**Investigator Full Name:** Hua Meng

**Investigator Title:** Director of the General Surgery Department & Obesity and Metabolic Disease Center of China-Japan Friendship Hospital

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Traditional Chinese Medicine Treatment

- Weight Change

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Postoperative patients are routinely provided with meal replacement recommendations and dietary plans.

**Intervention Names:**

- Other: Diet and meal replacements

**Label:** nutrition intervention group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Chinese herbal treatment is given on the basis of routine dietary intervention.

**Intervention Names:**

- Drug: Spleen Invigorating and Weight Reducing Decoction

- Other: Diet and meal replacements

**Label:** Traditional Chinese Medicine combined with nutritional intervention

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Traditional Chinese Medicine combined with nutritional intervention

**Description:** 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.

**Name:** Spleen Invigorating and Weight Reducing Decoction

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Traditional Chinese Medicine combined with nutritional intervention

- nutrition intervention group

**Description:** The dietitian provides recommended meal plans based on body weight, and meal replacements are used postoperatively.

**Name:** Diet and meal replacements

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Percentage change in body weight

**Time Frame:** Before bariatric surgery, 1 month after surgery, and 3 months after surgery.

#### Secondary Outcomes

**Measure:** Traditional Chinese Medicine syndrome score

**Time Frame:** Before bariatric surgery, 1 month after surgery, and 3 months after surgery.

**Description:** HbA1c, blood glucose, insulin levels

**Measure:** blood glucose indicators

**Time Frame:** Before bariatric surgery, 1 month after surgery, and 3 months after surgery.

**Description:** total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol

**Measure:** blood lipid profile

**Time Frame:** Before bariatric surgery, 1 month after surgery, and 3 months after surgery.

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** bucmyishan@163.com

**Name:** Huang Yishan, doctor

**Phone:** 18810621201

**Role:** CONTACT

**Contact 2:**

**Email:** menghuade@hotmail.com

**Name:** Meng Hua, doctor

**Phone:** 18611457779

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Country:** China

**Facility:** China-Japan Friendship Hospital

**Status:** RECRUITING

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001836

- Term: Body Weight Changes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M18102

- Name: Weight Loss

- Relevance: HIGH

- As Found: Weight Loss

- ID: M5114

- Name: Body Weight

- Relevance: HIGH

- As Found: Weight

- ID: M5115

- Name: Body Weight Changes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001835

- Term: Body Weight

- ID: D000015431

- Term: Weight Loss

### Intervention Browse Module - Browse Branches

- Abbrev: HB

- Name: Herbal and Botanical

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T317

- Name: Tribulus

- Relevance: LOW

- As Found: Unknown

- ID: T63

- Name: Astragalus

- Relevance: LOW

- As Found: Unknown

- ID: T181

- Name: Hawthorn

- Relevance: LOW

- As Found: Unknown

- ID: T107

- Name: Chinese Rhubarb

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
