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

NCT03325179 | Unknown

• 1 other identifier: shutcmidd
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss; Simple Obesity

Keywords

Simple Obesity; Thread-embedding Therapy; Acupuncture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 Arms (1)

participants received treatment

EXPERIMENTAL

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

Interventions

Thread-embedding Therapy OTHER

participants received treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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；
• participants who did not complete dietary control and physical exercise as the protocol described.

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead

Study Sites (1)

Institute of Digestive Diseases of Longhua Hospital affiliate to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Miao Wang

CONTACT

+86-64385700; wangmiao_126@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2017
• First Posted: October 30, 2017
• Study Start: January 3, 2017
• Primary Completion: December 31, 2017
• Study Completion: March 31, 2018
• Last Updated: October 30, 2017

Record last verified: 2017-06

Locations

CN (1)