NCT02108236

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
22 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

1.4 years

First QC Date

March 30, 2014

Last Update Submit

March 25, 2015

Conditions

ObesityOverweight

Keywords

acupuncturechinese traditional medicine

Outcome Measures

Primary Outcomes (1)

  • body mass index(BMI)

    2 month after treatment

Secondary Outcomes (6)

  • waist-to-hip ratio (WHR)

    2 month after treatment

  • Blood sugar

    2 month after treatment

  • Total cholesterol

    2 month after treatment

  • Triglycerides

    2 month after treatment

  • High-density lipoprotein cholesterol

    2 month after treatment

  • +1 more secondary outcomes

Study Arms (2)

Blank control group

NO INTERVENTION

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

intervention group

ACTIVE COMPARATOR

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

Device: acupuncture

Interventions

acupunctureDEVICE

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).

intervention group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, 150040, China

RECRUITING

MeSH Terms

Conditions

ObesityOverweight

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Sun Zhongren

    First Affiliated Hospital of Heilongjiang Chinese Medicine University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xie Ning, PhD

CONTACT

086 045182111401xiening2014@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
the head of institute of chinese medicine and translational science of First Affiliated Hospital

Study Record Dates

First Submitted

March 30, 2014

First Posted

April 9, 2014

Study Start

May 1, 2014

Primary Completion

October 1, 2015

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

CN(1)