Clinical trial NCT03325179: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Weight Loss
Simple Obesity
Keywords: Simple Obesity
Thread-embedding Therapy
Acupuncture
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The change Body Weight
timeFrame: participants will receive Thread-embedding Therapy twice a week lasting for 16 weeks subsequently.8 times in all.
Secondary outcomes:
measure: The effection on cholesterol
timeFrame: 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.
measure: The effection on triglyceride
timeFrame: 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.
measure: The effection on fasting blood glucose
timeFrame: 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.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Institute of Digestive Diseases of Longhua Hospital affiliate to Shanghai University of Traditional Chinese Medicine
state: Shanghai
Study officials:
References: