Integrated Traditional Chinese Medicine Program for Metabolic Syndrome

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

This study is testing a combined approach of Chinese herbal medicine and laser acupuncture to see if it can help people with metabolic syndrome improve their health over six months.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 20 Years to 75 Years
• Sex: All
• Sponsor: Chang Gung Memorial Hospital (other)
• Locations: 1 site (Taoyuan)
• Trial ID: NCT06703788 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of an integrated traditional Chinese medicine (TCM) program aimed at improving metabolic syndrome over six months. Participants will receive a combination of Chinese herbal medicine and laser acupuncture, along with regular checkups and lifestyle monitoring. The study also investigates the role of gut microbiome and lifestyle factors in the management of metabolic syndrome. By exploring these elements, the research aims to provide a holistic approach to treating obesity and its related complications.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 to 75 with central obesity or other metabolic syndrome indicators.

Not a fit: Patients with uncontrolled endocrine disorders or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could offer a novel and effective treatment option for patients struggling with metabolic syndrome.

How similar studies have performed: Previous studies have shown promising results with traditional Chinese medicine approaches for metabolic conditions, suggesting potential for success in this integrated program.

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

Where this trial is running

Taoyuan

• Chang Gung Memorial Hospital, Taoyuan and Linkou branches — Taoyuan, Taiwan (RECRUITING)

Study contacts

• Study coordinator: Hsing-Yu Chen, M.D., Ph.D.

Conditions: Obesity, Metabolic Syndrome, Dyslipidemias, Diabetes Mellitus, obesity, metabolic syndrome, dyslipidemia, diabetes mellitus