- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07646457
Comparative Effectiveness of Western Pharmacotherapy Versus Integrative Western and Traditional Chinese Medicine for Weight Management in Central Taiwan: A Real-World Cohort Study
June 10, 2026 updated by: National Yang Ming Chiao Tung University
Obesity is a major public health issue.
While modern Western pharmacotherapies (e.g., GLP-1 receptor agonists) and Traditional Chinese Medicine (TCM) are utilized for weight management, the comparative effectiveness of their integration remains unclear.
This study aims to compare the effects of Western medicine (WM) alone versus integrative WM and TCM on body weight and composition.
A retrospective cohort study design will be employed, aiming to enroll approximately 500 patients (BMI ≥ 27) receiving treatment at a regional hospital in Central Taiwan.
Participants will be categorized into the WM-only or WM+TCM groups.
The primary outcome is the percentage of total body weight loss (%TBWL) at 6 and 12 months.
Secondary outcomes include changes in body composition, including fat percentage and the muscle-to-fat ratio (MFR).
Statistical analysis will utilize Propensity Score Matching (PSM) or Inverse Probability of Treatment Weighting (IPTW) to balance baseline differences and Mixed-Effects Models for Repeated Measures (MMRM) for longitudinal data analysis.
Interaction effects between different WM modalities and TCM will be explored (sub-analysis).
Preliminary analysis indicated that individualized treatment significantly reduced body fat and increased MFR.
This study anticipates further clarifying the advantages of integrative WM+TCM and identifying the optimal synergistic combinations, providing crucial real-world evidence for clinical weight management strategies.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Observational
Enrollment (Actual)
296
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan, 112
- National Yang Ming Chiao Tung University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult patients with overweight or obesity receiving weight management treatment in a hospital-based outpatient setting in Taiwan.
Participants were identified from a retrospective clinical database and received pharmacologic therapy, primarily semaglutide, with or without adjunctive medications and/or traditional Chinese medicine interventions.
Description
Inclusion Criteria:
- Adults aged ≥20 years
- Obesity defined by Health Promotion Administration, Taiwan: BMI ≥27 kg/m², or BMI ≥24 kg/m² with metabolic comorbidities
- Received weight management treatment
- Primary pharmacologic therapy with: Rybelsus® (oral semaglutide), or Ozempic® (subcutaneous semaglutide)
- May have received adjunctive weight-loss medications, including: Mounjaro® (tirzepatide), SGLT2 inhibitors, Contrave® (naltrexone/bupropion)
Exclusion Criteria:
- Incomplete data, including missing baseline measurements or absence of follow-up records, precluding assessment of treatment effectiveness
- Pregnancy or breastfeeding
- History of bariatric surgery during the study period (e.g., gastric bypass, gastric banding)
- Presence of major medical conditions that may significantly affect body weight independent of obesity treatment (e.g., active malignancy, end-stage organ failure)
- Patients deemed unsuitable for inclusion by the investigators (e.g., poor treatment adherence or unreliable data)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage change in body weight associated with Chinese herbal medicine use
Time Frame: From baseline to end of follow-up (up to 14 months)
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Percentage change in body weight from baseline will be calculated and compared between participants exposed to Chinese herbal medicine and non-exposed participants during the study period.
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From baseline to end of follow-up (up to 14 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2026
Primary Completion (Actual)
April 28, 2026
Study Completion (Estimated)
June 30, 2026
Study Registration Dates
First Submitted
May 18, 2026
First Submitted That Met QC Criteria
June 10, 2026
First Posted (Actual)
June 12, 2026
Study Record Updates
Last Update Posted (Actual)
June 12, 2026
Last Update Submitted That Met QC Criteria
June 10, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 115005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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