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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03325179
Recruitment Status : Unknown
Verified June 2017 by Shanghai University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : October 30, 2017
Last Update Posted : October 30, 2017
Sponsor:
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Weight Loss Simple Obesity Other: Thread-embedding Therapy Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial of Acupoint Thread-embedding Therapy for Simple Obesity
Actual Study Start Date : January 3, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: participants received treatment
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



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


Secondary Outcome Measures :
  1. The effection on cholesterol [ Time Frame: 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. ]
    a target examined by blood test, in order to compare the Lipid metabolism

  2. The effection on triglyceride [ Time Frame: 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. ]
    a target examined by blood test, in order to compare the Lipid metabolism

  3. The effection on fasting blood glucose [ Time Frame: 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. ]
    to compare the level of glucose in order to get the message of improvement of blood glucose disorder by our therapy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03325179


Contacts
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Contact: Miao Wang +86-64385700 ext 9507 wangmiao_126@126.com

Locations
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China, Shanghai
Institute of Digestive Diseases of Longhua Hospital affiliate to Shanghai University of Traditional Chinese Medicine Recruiting
Shanghai, Shanghai, China, 200032
Contact: Guang Ji    +86-64385700 ext 9503    jiliver@vip.sina.com   
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine

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Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03325179    
Other Study ID Numbers: shutcmidd
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai University of Traditional Chinese Medicine:
Simple Obesity
Thread-embedding Therapy
Acupuncture
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes