Comparative Effectiveness of Western Pharmacotherapy Versus Integrative Western and Traditional Chinese Medicine for Weight Management in Central Taiwan: A Real-World Cohort Study
10. juni 2026 opdateret af: 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.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
296
Kontakter og lokationer
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Studiesteder
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Taipei, Taiwan, 112
- National Yang Ming Chiao Tung University
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Deltagelseskriterier
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Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percentage change in body weight associated with Chinese herbal medicine use
Tidsramme: 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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Samarbejdspartnere og efterforskere
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. april 2026
Primær færdiggørelse (Faktiske)
28. april 2026
Studieafslutning (Anslået)
30. juni 2026
Datoer for studieregistrering
Først indsendt
18. maj 2026
Først indsendt, der opfyldte QC-kriterier
10. juni 2026
Først opslået (Faktiske)
12. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. juni 2026
Sidst verificeret
1. januar 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 115005
Plan for individuelle deltagerdata (IPD)
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