NCT06703788

Integrated Traditional Chinese Medicine Day Care Program for Metabolic Syndrome

Establishing a Traditional Chinese Medicine Day Care Program for the Prevention and Treatment of Metabolic Syndrome

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate if a integrated tradtional Chinese medicine (TCM) program for improving metabolic syndrome is applicable. It will also learn about the importance of gut microbiome of subjects with ineffective management. The main questions it aims to answer are: Does a integrated tradtional Chinese medicine (TCM) program could improve metabolic syndrome in six months? Researchers will also explore the determinant factors of successful improvement in metabolic syndrome, including gut microbiome, life style, TCM management compliance. Participants will: Receive integrated TCM program for managing metabolic syndrome. Visit the clinic once every 2-4 weeks for checkups and tests Keep a diary of diet and life style

Detailed description

Metabolic syndrome, as one of the major diseases of modern civilization, significantly impacts cardiovascular, cerebrovascular diseases, and cancer, necessitating interdisciplinary collaboration for its prevention and treatment. Currently, the "National Health Insurance Metabolic Syndrome Prevention and Treatment Program" provides health education and consultation services, but these are limited to the field of Western medicine. Our research team's previous studies have found a correlation between Chinese medicine constitution and leptin levels, demonstrating the unique value of Chinese medicine in personalized health education and dietary recommendations. In terms of medication, a variety of drugs are available to control hyperlipidemia, hypertension, and hyperglycemia, but for patients in the early stages of metabolic syndrome, exercise and dietary adjustments remain the primary methods. Obesity and its related complications impose significant economic burdens on both society and individuals. Currently, the main methods of treating obesity include lifestyle adjustments, pharmacological interventions, and weight-loss surgery. However, these methods present challenges in maintenance, medication risks, and side effects. This study also considers the potential value of Chinese herbal medicine and laser acupuncture, aiming to assess their role in the prevention and treatment of metabolic syndrome. Retrospective studies have shown that various Chinese herbs are effective in weight reduction and improving metabolic indicators, and laser acupuncture has shown promise as a method of weight reduction. The project's objectives include expert meetings to explore models of Chinese medicine in the management of metabolic syndrome to discuss the healthcare models of TCM in the prevention and treatment of metabolic syndrome in clinical practice.

Conditions

• Obesity
• Metabolic Syndrome
• Dyslipidemias
• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	A fiixed combination of Chinese herbal medicine	a fixed combination of Chinese herbal medicine with Ma-Xing-Gang-Shi-Tang (initiate at 2 grams, with increments of 0.5 grams every 2-4 weeks, up to a maximum dose of 4 grams once daily) and Coptis chinensis (initiate at 0.5 grams, with increments of 0.5 grams every 2-4 weeks, up to a maximum dose of 1 gram once daily), twice a day
DEVICE	Laser acupuncture	Laser acupuncture could be used based on medication therapy at following acupoints: CV9, ST25, SP15, ST28, ST40, and two auricular points (stomach and hunger points)

Timeline

• Start date: 2024-11-20
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2024-11-25
• Last updated: 2024-11-25

Locations

1 site across 1 country: Taiwan