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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03325179
• Other study ID #: shutcmidd
• Status: Recruiting
• Phase: N/A
• First received: September 3, 2017
• Last updated: October 26, 2017
• Start date: January 3, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: June 2017
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Miao Wang
• Phone: +86-64385700
• Email: wangmiao_126[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid
• Simple Obesity
• Weight Loss

Intervention

Other:
• Thread-embedding Therapy

Locations

Country	Name	City	State
China	Institute of Digestive Diseases of Longhua Hospital affiliate to Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.