- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01975168
The Effect Evaluation of Laser Acupuncture in Obesity
November 5, 2013 updated by: Cheng-Che Lin, Kaohsiung Medical University Chung-Ho Memorial Hospital
A randomized double-blind placebo-controlled crossover trial is conducted.
200 subjects aged above 20 years with body mass index (BMI) more than 25 kg/m2 are randomly divided into 2 groups (Group 1 and Group 2).
Group 1 receives laser acupuncture therapy first while Group 2 receives sham laser acupuncture therapy first.
After 12 weeks of treatment and 14 days of washout, Group 1 switch to sham laser acupuncture therapy while Group 2 switch to laser acupuncture for 12 weeks.
The subjects are treated with a gallium aluminum arsenide Handylaser Trion, which is used to apply at each of the acupuncture points for 10 seconds every time, 3 times per week.
The measurements of outcomes are performed in the beginning, weekly during treatment, and monthly after treatment for 3 months.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cheng-Che Lin, MD
- Phone Number: 6422 +8863121101
- Email: abcmacoto@gmail.com
Study Contact Backup
- Name: Chen-Cheng Yang, MD
- Phone Number: +886929919132
- Email: cheng10042001@yahoo.com.tw
Study Locations
-
-
-
Kaohsiung, Taiwan
- Recruiting
- Chinese Medicine Department Clinic, Kaohsiung Medical University
-
Contact:
- Cheng-Che Lin
- Phone Number: 6422 +8863121101
- Email: abcmacoto@gmail.com
-
Contact:
- Chen-Cheng Yang
- Phone Number: +886929919132
- Email: cheng10042001@yahoo.com.tw
-
Principal Investigator:
- Chen-Cheng Yang, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Body Mass Index over 25 kg/m2 or Waist girth over 80cm in female, waist girth over 90cm in male
Exclusion Criteria:
- Pathmakers user
- Epilepsy history
- Pregnancy
- Immuno-inhibiting agents user
- Malignancy
- Skin contacted disease
- Weight controlled agents user during trial period
- Eating disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
arrange laser acupuncture intervention for 12 weeks, then cross over to sham laser acupuncture intervention for 12 weeks
|
intervention interval is 3 times per week for 12 weeks
Other Names:
|
Sham Comparator: Group 2
arrange sham laser acupuncture for 12 weeks, then cross over to laser acupuncture for 12 weeks
|
intervention interval is 3 times per week for 12 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
body composition
Time Frame: 12 weeks
|
body weight
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
body mass index
Time Frame: 12 weeks
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
waist circumference
Time Frame: 12 weeks
|
12 weeks
|
blood pressure
Time Frame: 12 weeks
|
12 weeks
|
hip circumference
Time Frame: 12 weeks
|
12 weeks
|
body fat
Time Frame: 12 weeks
|
12 weeks
|
heart rate
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Cheng-Che Lin, MD, Doctor of Chinese Medicine Department, Kaohsiung Medical University Hospital
- Study Director: Hung-Yi Chuang, ScD, MD, Department of Public Health, College of Health Sciences, Kaohsiung Medical University
- Principal Investigator: Chen-Cheng Yang, MD, Family Medicine Department, Kaohsiung Medical University Hospital and Kaohsiung Municipal Ta-Tung Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Anticipated)
July 1, 2015
Study Completion (Anticipated)
July 1, 2015
Study Registration Dates
First Submitted
October 23, 2013
First Submitted That Met QC Criteria
November 1, 2013
First Posted (Estimate)
November 3, 2013
Study Record Updates
Last Update Posted (Estimate)
November 6, 2013
Last Update Submitted That Met QC Criteria
November 5, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMUH-LAAC-OB-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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