NCT06419764

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 17, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

May 14, 2024

Last Update Submit

May 14, 2024

Conditions

Traditional Chinese Medicine TreatmentWeight Change

Outcome Measures

Primary Outcomes (1)

  • Percentage change in body weight

    Before bariatric surgery, 1 month after surgery, and 3 months after surgery.

Secondary Outcomes (3)

  • Traditional Chinese Medicine syndrome score

    Before bariatric surgery, 1 month after surgery, and 3 months after surgery.

  • blood glucose indicators

    Before bariatric surgery, 1 month after surgery, and 3 months after surgery.

  • blood lipid profile

    Before bariatric surgery, 1 month after surgery, and 3 months after surgery.

Study Arms (2)

nutrition intervention group

ACTIVE COMPARATOR

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

Other: Diet and meal replacements

Traditional Chinese Medicine combined with nutritional intervention

EXPERIMENTAL

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

Drug: Spleen Invigorating and Weight Reducing DecoctionOther: Diet and meal replacements

Interventions

Spleen Invigorating and Weight Reducing DecoctionDRUG

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.

Traditional Chinese Medicine combined with nutritional intervention
Diet and meal replacementsOTHER

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

Traditional Chinese Medicine combined with nutritional interventionnutrition intervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI ≥ 27.5 kg/m²;
  • Undergoing metabolic bariatric surgery;
  • Traditional Chinese Medicine syndrome differentiation classified as Spleen Deficiency and Excess Dampness syndrome.

You may not qualify if:

  • Contraindications for metabolic bariatric surgery;
  • Type 1 diabetes;
  • Complicated by other significant systemic diseases, such as severe liver and kidney diseases, malignant tumors, psychiatric disorders, etc;
  • Concurrent use of other medications or treatments that may affect body weight, such as metformin, semaglutide, endoscopic interventions, etc;
  • Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Body Weight Changes

Interventions

Diet

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Central Study Contacts

Huang Yishan, doctor

CONTACT

18810621201bucmyishan@163.com

Meng Hua, doctor

CONTACT

18611457779menghuade@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the General Surgery Department & Obesity and Metabolic Disease Center of China-Japan Friendship Hospital

Study Record Dates

First Submitted

May 14, 2024

First Posted

May 17, 2024

Study Start

February 1, 2024

Primary Completion

July 1, 2024

Study Completion

July 1, 2025

Last Updated

May 17, 2024

Record last verified: 2024-05

Locations

CN(1)