Real-World Registry Study of Integrated Traditional Chinese and Western Medicine for Obesity

NCT07448090 | Recruiting DMC

• 1 other identifier: HBZY2024-C60-03
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is a major risk factor for cardiovascular disease, diabetes, cancer, and other chronic conditions. Due to its complex etiology and frequent comorbidities, effective obesity management requires comprehensive and individualized approaches. This study is a multicenter, prospective, real-world registry designed to evaluate integrated traditional Chinese medicine (TCM) and Western medicine interventions for obesity. The study will enroll at least 10,000 individuals with obesity from urban and rural populations. Multimodal data, including electronic medical records, laboratory test results, imaging data, and lifestyle information, will be collected. The effectiveness of integrated TCM and Western medicine interventions will be assessed across different age groups, disease stages, and obesity-related constitution types. In addition, disease progression patterns and key prevention and treatment points will be explored. Health economic analyses will be conducted to evaluate the cost-effectiveness of different obesity management strategies, providing real-world evidence to support public health policy and the optimization of integrated obesity prevention and management approaches.

Conditions

Obesity & Overweight; Obesity (Disorder)

Keywords

Obesity; Real-World Study; Integrated Traditional Chinese and Western Medicine; Prospective Cohort; Registry Study

Outcome Measures

Primary Outcomes (1)

• Percentage reduction in body weight relative to baseline

  Percentage change in body weight from baseline to 12 weeks and 24 weeks after treatment, calculated as \[(body weight at each follow-up time point - baseline body weight) / baseline body weight\] × 100%.

  Baseline, 12 weeks after treatment, 24 weeks after treatment

Study Arms (1)

Obesity Patients Cohort

A prospective real-world observational cohort including adult patients with obesity (BMI ≥28 kg/m²). Participants receive routine clinical care and may be exposed to integrated traditional Chinese and Western medicine interventions, pharmacologic treatments, lifestyle interventions, or other standard-of-care approaches. No randomization or predefined intervention assignment is applied.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 18 years or older with obesity (body mass index ≥28.0 kg/m²), diagnosed according to the Chinese clinical guidelines for obesity. Eligible participants have relatively stable body weight within the past three months and provide written informed consent. Patients with severe organ dysfunction, secondary or drug-induced obesity, pregnancy or lactation, or other conditions deemed unsuitable by investigators are excluded.

You may qualify if:

• Age 18 years and above, gender not restricted;
• Weight fluctuation within the last 3 months is ≤ 5% and BMI is ≥ 28.0 kg/m2;
• Good compliance, willing to follow the follow-up principles;
• Agree to sign the informed consent form.

You may not qualify if:

• Co-existing severe diseases of the heart, liver, lungs, kidneys, brain, blood, neuro-psychiatric system, or other vital organs.
• Secondary obesity (obesity attributable to another clearly diagnosed disorder, e.g., hypothalamic or pituitary inflammation, tumours or trauma, Cushing's syndrome, hypothyroidism, hypogonadism, polycystic ovary syndrome, etc.).
• Iatrogenic obesity (obesity resulting from drugs or therapeutic interventions administered for other conditions).
• Pregnant or lactating women.
• Subjects whom the investigator deems unsuitable for participation in this study.

Sponsors & Collaborators

• Hubei Hospital of Traditional Chinese Medicine: lead
• Union Hospital of Huazhong University of Science and Technology: collaborator
• Heilongjiang Quanle Pharmaceutical Co., Ltd.: collaborator
• Huazhong University of Science and Technology: collaborator

Study Sites (1)

Hubei Provincial Hospital of Traditional Chinese Medicine

Wuhan, Hubei, 430000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool, and oral (tongue coating) samples will be collected and retained. Blood samples include serum, plasma, and cellular components. Stool and oral samples will be stored for microbiome and DNA-related analyses. All biospecimens will be collected and stored according to standard operating procedures for future research related to obesity and metabolic disorders.

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• ChenGang ChenGang, Doctor

  Hubei College of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ChenGang Professor ChenGang, Doctor

CONTACT

+86 17720376888; 250149875@qq.com

ZhuHui ZhuHui, Doctor

CONTACT

+86 13545094802; 865057084@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: November 26, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)