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Clinical Trials/NCT03325179
NCT03325179
Unknown
Not Applicable

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

Shanghai University of Traditional Chinese Medicine1 site in 1 country100 target enrollmentJanuary 3, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Weight Loss
Sponsor
Shanghai University of Traditional Chinese Medicine
Enrollment
100
Locations
1
Primary Endpoint
The change Body Weight
Last Updated
8 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 3, 2017
End Date
March 31, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Shanghai University of Traditional Chinese Medicine
Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

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 Outcomes

  • The effection on cholesterol(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(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(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.)

Study Sites (1)

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