Integrated Traditional Chinese Medicine Day Care Program for Metabolic Syndrome

NCT ID: NCT06703788

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-20
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Integrated traditional Chinese medicine care program

Integrated traditional Chinese medicine (TCM) care program for metabolic syndrome, including herbal medicine, laser acupuncture, and diet and lifestyle education based on TCM theory.

Group Type: EXPERIMENTAL

A fiixed combination of Chinese herbal medicine

Intervention Type: DRUG

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

Laser acupuncture

Intervention Type: DEVICE

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)

Interventions

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

Intervention Type: DRUG

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)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age: 20 to 75 years who are eligible for health insurance. (Required)

Additional Criteria (Any one of the following):

2-1. Central Obesity: Waist circumference ≥90 cm for men or ≥80 cm for women. 2-2. Elevated blood glucose levels (≥100mg/dL or currently on medication control) 2-3. Elevated blood pressure (systolic pressure ≥130mmHg, diastolic pressure ≥85mmHg, or currently on medication control) 2-4. Elevated triglycerides (≥150mg/dL, or currently on medication control).High-Density Lipoprotein Cholesterol (HDL-C) < 40mg/dL for men or < 50mg/dL for women, or currently on medication) 2-5. Obesity: BMI ≥ 37.5 or BMI ≥ 32.5 with high-risk complications, such as type 2 diabetes mellitus with glycated hemoglobin levels remaining above 7.5% despite medical treatment, hypertension, sleep apnea syndrome, or fatty liver.

Exclusion Criteria

• 1. Pregnant or breast-feeding women 2. Endocrine disorders (uncontrolled hypo/hyperthyroidism, adrenal gland disorder) 3. Diagnosis of neurologic or psychiatric diseases 4. Liver or renal dysfunction (AST/ALT higher than 3 times of upper normal limits; eGFR < 60 mL/min/1.73 m2) 5. Acute stress condition (severe infection, receive major surgery in the recent 1 month) 6. Vision, or hearing impairment 7. With other clinical trial medication 8. With Chinese herbal medicine, acupuncture, electroacupuncture or other traditional Chinese medicine (TCM) managements for obesity or metabolic syndrome in the recent 1 month 9. Heavy smoker, alcoholism or substance abuse 10. Severe organ dysfunction: malignancies, autoimmune diseases

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health and Welfare, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hsing-Yu Chen, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chang Gung Memorial Hospital, Taoyuan and Linkou branches

Taoyuan District, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Hsing-Yu Chen, M.D., Ph.D.

Role: CONTACT

b8705016@gmail.com

886-975366119

Facility Contacts

Yi-Chiu Lee, Master degree

Role: primary

yichiu@cgmh.org.tw

886-3-3196200 ext. 2677

References

Liao YN, Chen HY, Yang CW, Lee PW, Hsu CY, Huang YT, Yang TH. Chinese herbal medicine is associated with higher body weight reduction than liraglutide among the obese population: A real-world comparative cohort study. Front Pharmacol. 2022 Sep 9;13:978814. doi: 10.3389/fphar.2022.978814. eCollection 2022.

Reference Type: BACKGROUND

PMID: 36160410 (View on PubMed)

Yu WL, Liao YN, Yang TH, Yang CW, Kao TI, Lee PW, Hsu CY, Huang JL, Huang YT, Chen HY. Laser Acupuncture versus Liraglutide in Treatment of Obesity: A Multi-Institutional Retrospective Cohort Study. Healthcare (Basel). 2024 Jun 26;12(13):1279. doi: 10.3390/healthcare12131279.

Reference Type: BACKGROUND

PMID: 38998814 (View on PubMed)

Other Identifiers

MOHW113-CMAP-M-113-000003-B

Identifier Type: -

Identifier Source: org_study_id