A Randomized Controlled Double Blinding Study of Intrader... | NCT00414505

Studies
A Randomized Controlled Double Blinding Study of Intradermal Acupuncture Treatment on Obesity

NCT00414505

Sponsor

Wonkwang University

Status

Unknown status

Last Update Posted

Jun 2, 2014Estimated

Enrollment

180Estimated

Phase

Phase 3

Conditions

Obesity

Interventions

Intradermal Acupuncture Treatment

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Not provided

Completion Date

Dec 2014Estimated

First Submitted Date

Dec 20, 2006

First Submission Date that Met QC Criteria

Dec 20, 2006

First Posted Date

Dec 21, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2014

Last Update Posted Date

Jun 2, 2014Estimated

Name	Class
Korea Institute of Oriental Medicine	OTHER_GOV

Description Module

Brief Summary

The purpose of this study is to determine whether intradermal acupuncture is effective and safe in the treatment of obesity.

Detailed Description

Recently the Studies of auricular acupuncture or Common Acupuncture on obesity have been conducted. Saam acupuncture, the Korean unique acupuncture, is famous with its high efficacy but not established by the scientific way yet. Thus, we tried a double-blind study on the effect of sa-am acupuncture on obesity using intradermal acupuncture.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Name	Type	Description	Arm Group Labels	Other Names
Intradermal Acupuncture Treatment	Device

Measure	Description	Time Frame
Bio-body impedance methods

Measure	Description	Time Frame
Cholesterol, Triglycerides, HDL LDL cholesterol

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI>25, regular menstruation, volunteer

Exclusion Criteria:

symptomatic obesity, acupuncture treatment within 3 months, >120kg, pregnancy or breast-feeding, hemophilia, dementia, mental illness, arrhythmia, liver cirrhosis, renal failure, pace maker, diabete mellitus, tuberculosis, steroid taker,

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sung-chul Kim	Contact	82-62-670-6442		kscndl@hanmail.net

Overall Officials

Name	Affiliation	Role
Sung-chul Kim, Ph.D.	Dept. of Acupuncture & Moxibustion, Wonkwang University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wonkwang University Hospital	Recruiting	Gwangju		503-310	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided