Back to resultsA Clinical Trial of Thread-embedding Therapy at Acupuncture Point for Simple Obesity
Primary Purpose
Weight Loss, Simple Obesity
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Thread-embedding Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss focused on measuring Simple Obesity, Thread-embedding Therapy, Acupuncture
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.
Sites / Locations
- Institute of Digestive Diseases of Longhua Hospital affiliate to Shanghai University of Traditional Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
participants received treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
The change Body Weight
a 5 percent of loss of body weight will be judged as effective
Secondary Outcome Measures
The effection on cholesterol
a target examined by blood test, in order to compare the Lipid metabolism
The effection on triglyceride
a target examined by blood test, in order to compare the Lipid metabolism
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.
Full Information
NCT ID
NCT03325179
First Posted
September 3, 2017
Last Updated
October 26, 2017
Sponsor
Shanghai University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03325179
Brief Title
A Clinical Trial of Thread-embedding Therapy at Acupuncture Point for Simple Obesity
Official Title
A Clinical Trial of Acupoint Thread-embedding Therapy for Simple Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 3, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
March 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Simple Obesity
Keywords
Simple Obesity, Thread-embedding Therapy, Acupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
participants received treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Thread-embedding Therapy
Primary Outcome Measure Information:
Title
The change Body Weight
Description
a 5 percent of loss of body weight will be judged as effective
Time Frame
participants will receive Thread-embedding Therapy twice a week lasting for 16 weeks subsequently.8 times in all.
Secondary Outcome Measure Information:
Title
The effection on cholesterol
Description
a target examined by blood test, in order to compare the Lipid metabolism
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.
Title
The effection on triglyceride
Description
a target examined by blood test, in order to compare the Lipid metabolism
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.
Title
The effection on fasting blood glucose
Description
to compare the level of glucose in order to get the message of improvement of blood glucose disorder by our therapy.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miao Wang
Phone
+86-64385700
Ext
9507
Email
wangmiao_126@126.com
Facility Information:
Facility Name
Institute of Digestive Diseases of Longhua Hospital affiliate to Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guang Ji
Phone
+86-64385700
Ext
9503
Email
jiliver@vip.sina.com
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial of Thread-embedding Therapy at Acupuncture Point for Simple Obesity
We'll reach out to this number within 24 hrs