NCT02254603

Brief Summary

The aim of this study is to examine the effects of combination of acupuncture and ayuveda yoga exercise on weight loss for the overweight.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started May 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 2, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

October 2, 2014

Status Verified

September 1, 2014

Enrollment Period

2 years

First QC Date

September 25, 2014

Last Update Submit

September 29, 2014

Conditions

Keywords

Obesity, ayuveda yoga exercise, acupuncture.

Outcome Measures

Primary Outcomes (1)

  • Reduce body mass index.

    Outcome measure compares the change in body mass index during 3 months treatment.

    Change from baseline in body mass index at 3 months

Secondary Outcomes (3)

  • Reduce waistline

    Change from baseline in waistline at 3 months

  • Change biochemical profile of blood

    Change from baseline in biochemical profile of blood at 3 months

  • Immune modulation

    Change from baseline in lymphocyte profile and polarization at 3 months

Study Arms (2)

Acupuncture controls

OTHER

Acupuncture group will receive 30-minutes treatment three times a week for 3 months.

Device: Acupuncture

acupuncture and yoga exercise

EXPERIMENTAL

Subject will receive a combination of acupuncture and yoga exercise three times a week for 3 months.

Device: AcupunctureBehavioral: Yoga exercise

Interventions

Acupuncture about 30 mins will be performed by a traditional Chinese physician three times a week for 3 months.

Acupuncture controlsacupuncture and yoga exercise
Yoga exerciseBEHAVIORAL

Subject will receive regular 60-minutes yoga exercise three times a week for 3 months.

acupuncture and yoga exercise

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \> 24

You may not qualify if:

  • Diagnosis of cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital

Changhua County, Taiwan

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Kuender D. Yang, PhD.

    Chang Bing Show Chwan Memorial Hospital

    STUDY CHAIR
  • Shu-Hui Yeh, PhD.

    Chang Bing Show Chwan Memorial Hospital & Central Taiwan University of Science and Technology

    STUDY DIRECTOR
  • Yu-Kwan Lu, MD.

    Show Chwan Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuender D. Yang, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, PhD, Professor

Study Record Dates

First Submitted

September 25, 2014

First Posted

October 2, 2014

Study Start

May 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

October 2, 2014

Record last verified: 2014-09

Locations