ObesityPhase 1/2NCT06703788
Integrated Traditional Chinese Medicine Day Care Program for Metabolic Syndrome
A Phase 1/2 study testing A fiixed combination of Chinese herbal medicine and Laser acupuncture in people with Obesity and Metabolic Syndrome, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Obesity, Metabolic Syndrome, Dyslipidemias
- What is being tested?
- A fiixed combination of Chinese herbal medicine and Laser acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Nov 2024to Dec 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital, Taoyuan and Linkou branches
Taoyuan, 330
Yi-Chiu Lee, Master degree, 886-3-3196200 ext. 2677, yichiu@cgmh.org.tw
About this study
Official title: Establishing a Traditional Chinese Medicine Day Care Program for the Prevention and Treatment of Metabolic Syndrome
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.
Read more
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
Read the 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
- Being tested
- A fiixed combination of Chinese herbal medicine, Laser acupuncture
- Keywords
- obesity, metabolic syndrome, dyslipidemia, diabetes mellitus, integrated traditional Chinese medicine care program
- Medical subject headings
- Obesity, Metabolic Syndrome, Dyslipidemias, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A fiixed combination of Chinese herbal medicineDrug
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 acupunctureDevice
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 group | Role | What they receive |
|---|---|---|
| Integrated traditional Chinese medicine care program | Experimental | Integrated traditional Chinese medicine (TCM) care program for metabolic syndrome, including herbal medicine, laser acupuncture, and diet and lifestyle education based on TCM theory. Receives: Drug: A fiixed combination of Chinese herbal medicine; Device: Laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite metabolic endpoint
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.
Measured: From date of enrollment until the date of end of study. Follow up parameters every one month, up to six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start20 Nov 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects with compatible with diagnosis of metabolic syndrome are the target of this study
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Responsible party
- Principal investigator, Hsing-Yu Chen, MD, Chang Gung Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703788
- Sponsor's protocol ID
- MOHW113-CMAP-M-113-000003-B
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing would be done upon adequate request and approval from the IRB committee of the Chang Gung Medical Foundation.
Publications
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.
PubMed 36160410Yu 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.
PubMed 38998814
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Traditional Chinese Medicine Day Care Program for the Prevention and Treatment of Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT06703788
- Acronym / sponsor ID
- MOHW113-CMAP-M-113-000003-B
- Conditions
- Obesity, Metabolic Syndrome, Dyslipidemias, Diabetes Mellitus
- Keywords
- obesity, metabolic syndrome, dyslipidemia, diabetes mellitus, integrated traditional Chinese medicine care program
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Study start
- 20 Nov 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects with compatible with diagnosis of metabolic syndrome are the target of this study
| Arm | Type | Receives |
|---|---|---|
| Integrated traditional Chinese medicine care program | Experimental | Drug: A fiixed combination of Chinese herbal medicine, Device: Laser acupunctureIntegrated traditional Chinese medicine (TCM) care program for metabolic syndrome, including herbal medicine, laser acupuncture, and diet and lifestyle education based on TCM theory. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 20 to 75 years who are eligible for health insurance. (Required)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A fiixed combination of Chinese herbal medicinea 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 | Drug | Integrated traditional Chinese medicine care program |
| Laser acupunctureLaser acupuncture could be used based on medication therapy at following acupoints: CV9, ST25, SP15, ST28, ST40, and two auricular points (stomach and hunger points) | Device | Integrated traditional Chinese medicine care program |
Primary outcome
The composite metabolic endpoint
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Results publication: PubMed 36160410Liao 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.
- Results publication: PubMed 38998814Yu 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.
- Individual participant dataSharing planned: No. Data sharing would be done upon adequate request and approval from the IRB committee of the Chang Gung Medical Foundation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing A fiixed combination of Chinese herbal medicine and Laser acupuncture in people with Obesity and Metabolic Syndrome, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsing-Yu Chen, M.D., Ph.D. (886-975366119, b8705016@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The composite metabolic endpoint (time frame: From date of enrollment until the date of end of study. Follow up parameters every one month, up to six months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06703788, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.