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

NCT ID: NCT06419764

Last Updated: 2024-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-07-31

Brief Summary

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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

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Conditions

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Traditional Chinese Medicine Treatment Weight Change

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nutrition intervention group

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

Group Type ACTIVE_COMPARATOR

Diet and meal replacements

Intervention Type OTHER

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

Traditional Chinese Medicine combined with nutritional intervention

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

Group Type EXPERIMENTAL

Spleen Invigorating and Weight Reducing Decoction

Intervention Type DRUG

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.

Diet and meal replacements

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DRUG

Diet and meal replacements

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hua Meng

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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China-Japan Friendship Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Huang Yishan, doctor

Role: CONTACT

18810621201

Meng Hua, doctor

Role: CONTACT

18611457779

Other Identifiers

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CCMNEWLABS

Identifier Type: -

Identifier Source: org_study_id

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