A fiixed combination of Chinese herbal medicineLaser acupuncture
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
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)
Study 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
Eligibility
Sex
ALL
Min age
20 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
The composite metabolic endpoint — From date of enrollment until the date of end of study. Follow up parameters every one month, up to six months. Body mass index (BMI) decrease one point (or body weight decrease at least 5% from baseline), waist circumstance decrease at least 3%, the glycated haemoglobin decrease at least 10% or lower than 5.7%, blood pressure \<130/80 mmHg, low-density lipoprotein cholesterol \<130 mg/dl and triglyceride \<150mg/dL will be used as composite metabolic outcome. Meet any of the above criteria is considered achieving the treatment goal.
Trial sites (1)
Facility
City
Region
Status
Chang Gung Memorial Hospital, Taoyuan and Linkou branches
Taoyuan
Taiwan
Recruiting
More Chang Gung Memorial Hospital trials in Taiwan
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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