Effectiveness and Safety of Acupuncture for Obesity and Over-weight People

Obesity Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02108236
• Other study ID #: Acupuncture-Obesity-2014-3
• Status: Recruiting
• Phase: N/A
• First received: March 30, 2014
• Last updated: March 25, 2015
• Start date: May 2014

Study information

• Verified date: March 2015
• Source: Heilongjiang University of Chinese Medicine
• Contact: Xie Ning, PhD
• Phone: 086 045182111401
• Email: xiening2014[@]163.com
• Is FDA regulated: No
• Health authority: China: First Affiliated Hospital of Heilongjiang University of Chinese Medicine
• Study type: Interventional

Clinical Trial Summary

To determine the efficacy and safety of acupuncture for obesity and overweight people in China.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• The individuals is phlegm-dampness constitution and female.

• Age is between 18 and 45 years.

• BMI is between 24 and 50.

• The individuals voluntarily sign the informed consent form.

• The individuals live in Harbin City of China.

Exclusion Criteria:

• Secondary obesity, eg:pituitary diseases, hypothalamic disorder, hypothyroidism, pancreatic diseases,hyperadrenocorticism, postmenopausal obesity etc.

• The individuals with server cardiovascular and cerebrovascular diseases and cancer.

• Having therapy for obesity in the last three months.

• The individuals do not adhere to the treatment or are with other treatments.

• Female individuals with pregnancy, lactation and planning a pregnancy in the two months.

• Critical patients or patients combined with liver and kidney damage.

• Individuals with visual and auditory memory disorders or psychosis.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Device:
• acupuncture
Zhong-wan (RN12), Liang-men (ST21), Shui-fen (RN9) and Qi-hai (RN6) and bilateral acupuncture points Dai-mai (GB26), Tian-shu (ST25), Zu-sanli (ST36), Feng-long(ST40) and Liang-qiu(ST34) will be applied through the skin by acupuncture for 30 minutes every time. Electro-acupuncture apparatus will be connected to both Dai-mai, Zu-sanli and Feng-long, Zhong-wan and Qi-hai for 30 minutes with interrupted waves (2/100HZ).

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Heilongjiang University of Chinese Medicine	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Heilongjiang University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body mass index(BMI)		2 month after treatment	No
Secondary	waist-to-hip ratio (WHR)		2 month after treatment	No
Secondary	Blood sugar		2 month after treatment	No
Secondary	Total cholesterol		2 month after treatment	No
Secondary	Triglycerides		2 month after treatment	No
Secondary	High-density lipoprotein cholesterol		2 month after treatment	No
Secondary	Low-density lipoprotein cholesterol		2 month after treatment	No