A Clinical Trial of Thread-embedding Therapy at Acupuncture Point for Simple Obesity

Study Overview
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Brief Summary
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Thread-embedding Therapy has been used for treating Obesity in recent years. This research is aimed to observe the clinical effect of thread-embedding therapy in treating Simple Obesity. One hundred patients is planned to be enrolled in the research and receive a thread-embedding therapy. The level of BMI, serum triglyceride, cholesterol and fasting blood glucose will be adopted for evaluation before and after therapy.

Detailed Description
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Each participant will receive thread-embedding therapy every two weeks, and eight times in all.Blood test will be taken at the beginning of the first week of the whole therapy, and at the end of the 8th therapy. During the periods of whole therapy, the participants shall follow diets control and physical exercise as the protocol described.

Official Title
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A Clinical Trial of Acupoint Thread-embedding Therapy for Simple Obesity

Conditions
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Weight Loss, Simple Obesity

Intervention / Treatment
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* Other: Thread-embedding Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with age from 18 to 60 years old; patients with BMI≥ 24, meanwhile waist more than 85 cm (for male) or 80 cm (for female); patients with diagnosed as central adiposity and/or Simple obesity according to the diagnosis criteria； patients who is willing to cooperate with the test treatment and signed informed consent. Exclusion Criteria: Pregnant or lactating women; patients who Syncope after acupuncture； patients who present hypersensitivity reactions after acupoint-embedding therapy; patients with serious heart, liver, kidney, brain and other diseases; patients with severe primary diseases; patients with psychiatric diseases； patients who did not meet the criteria for the inclusion criteria while investigators find out during the trial; participants who did not complete dietary control and physical exercise as the protocol described.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: participants received treatment<br>100 participants who are diagnosed as simple obesity under the standards of... are planned to enrolled in the trial. Each will receive Thread-embedding therapy. | Other: Thread-embedding Therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change Body Weight | a 5 percent of loss of body weight will be judged as effective | participants will receive Thread-embedding Therapy twice a week lasting for 16 weeks subsequently.8 times in all. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effection on cholesterol | a target examined by blood test, in order to compare the Lipid metabolism | Therapy is the same as mentioned above. Participants will take blood test at the beginning of the first week of the therapy, and at the end of the 16th week. | 
| The effection on triglyceride | a target examined by blood test, in order to compare the Lipid metabolism | Therapy is the same as mentioned above. Participants will take blood test at the beginning of the first week of the therapy, and at the end of the 16th week. | 
| The effection on fasting blood glucose | to compare the level of glucose in order to get the message of improvement of blood glucose disorder by our therapy. | Therapy is the same as mentioned above. Participants will take blood test at the beginning of the first week of the therapy, and at the end of the 16th week. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Simple Obesity, Thread-embedding Therapy