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

Primary Purpose

Obesity, Overweight

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
acupuncture
Sponsored by
Heilongjiang University of Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring acupuncture, chinese traditional medicine

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Heilongjiang University of Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Blank control group

intervention group

Arm Description

A control group of patients is put on a waiting list for no intervention and remaining unchanged lifestyle.

An intervention group of patients is put on a waiting list for acupuncture treatment.

Outcomes

Primary Outcome Measures

body mass index(BMI)

Secondary Outcome Measures

waist-to-hip ratio (WHR)
Blood sugar
Total cholesterol
Triglycerides
High-density lipoprotein cholesterol
Low-density lipoprotein cholesterol

Full Information

First Posted
March 30, 2014
Last Updated
March 25, 2015
Sponsor
Heilongjiang University of Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02108236
Brief Title
Effectiveness and Safety of Acupuncture for Obesity and Over-weight People
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heilongjiang University of Chinese Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
acupuncture, chinese traditional medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blank control group
Arm Type
No Intervention
Arm Description
A control group of patients is put on a waiting list for no intervention and remaining unchanged lifestyle.
Arm Title
intervention group
Arm Type
Active Comparator
Arm Description
An intervention group of patients is put on a waiting list for acupuncture treatment.
Intervention Type
Device
Intervention Name(s)
acupuncture
Intervention Description
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).
Primary Outcome Measure Information:
Title
body mass index(BMI)
Time Frame
2 month after treatment
Secondary Outcome Measure Information:
Title
waist-to-hip ratio (WHR)
Time Frame
2 month after treatment
Title
Blood sugar
Time Frame
2 month after treatment
Title
Total cholesterol
Time Frame
2 month after treatment
Title
Triglycerides
Time Frame
2 month after treatment
Title
High-density lipoprotein cholesterol
Time Frame
2 month after treatment
Title
Low-density lipoprotein cholesterol
Time Frame
2 month after treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xie Ning, PhD
Phone
086 045182111401
Email
xiening2014@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun Zhongren
Organizational Affiliation
First Affiliated Hospital of Heilongjiang Chinese Medicine University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Heilongjiang University of Chinese Medicine
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150040
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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