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

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

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.

Study Overview

• Status: Unknown
• Conditions: Weight Loss; Simple Obesity
• Intervention / Treatment: Other: Thread-embedding 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Institute of Digestive Diseases of Longhua Hospital affiliate to Shanghai University of Traditional Chinese Medicine
      • Contact: Guang Ji; Phone Number: 9503 +86-64385700; Email: jiliver@vip.sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: participants received treatment; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2017
• Primary Completion (Anticipated): December 31, 2017
• Study Completion (Anticipated): March 31, 2018

Study Registration Dates

• First Submitted: September 3, 2017
• First Submitted That Met QC Criteria: October 26, 2017
• First Posted (Actual): October 30, 2017

Study Record Updates

• Last Update Posted (Actual): October 30, 2017
• Last Update Submitted That Met QC Criteria: October 26, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Acupuncture; Simple Obesity; Thread-embedding Therapy
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss; Obesity, Morbid
• Other Study ID Numbers: shutcmidd

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No