East-West Collaborative Medicine Using Bee-Venom Acupunct... | NCT01369238

Studies
East-West Collaborative Medicine Using Bee-Venom Acupuncture on Whiplash-Associated Disorders

NCT01369238

Sponsor

Korean Pharmacoacupuncture Institute

Status

Unknown status

Last Update Posted

Jun 8, 2011Estimated

Enrollment

90Estimated

Phase

Not Applicable

Conditions

Whiplash Injuries

Interventions

Bee Venom Acupuncture Therapy
zaltoprofen

Countries

Not provided

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

Jun 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Jan 2012Estimated

Completion Date

Mar 2012Estimated

First Submitted Date

May 12, 2011

First Submission Date that Met QC Criteria

Jun 7, 2011

First Posted Date

Jun 8, 2011Estimated

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

Jun 7, 2011

Last Update Posted Date

Jun 8, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Purpose of study
1. To evaluate the efficacy of East-West collaborative medicine using Bee-Venom Acupuncture Therapy on Whiplash-Associated Disorders using VAS scale
2. To evaluate the efficacy of East-West collaborative medicine using Bee-Venom Acupuncture Therapy on Whiplash-Associated Disorders using NDI, BDI, SF-36, and EQ-5D.
Interventions & Groups
1. group 1: Bee-Venom Acupuncture Therapy
2. group 2: zaltoprofen
3. group 3: Bee-Venom Acupuncture Therapy & zaltoprofen

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Bee Venom Acupuncture & zaltoprofen	Experimental	Device: Bee Venom Acupuncture Therapy Drug: zaltoprofen
zaltoprofen	Active Comparator	Drug: zaltoprofen
Bee Venom Acupuncture	Active Comparator	Device: Bee Venom Acupuncture Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bee Venom Acupuncture Therapy	Device	1:4000, SC 1cc/day, 2~3days/wk, for 1 month	Bee Venom Acupuncture Bee Venom Acupuncture & zaltoprofen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain scores on Visual Analogue Scale		changes from baseline in VAS at 1 month

Secondary Outcomes

Measure	Description	Time Frame
neck disability scores on Neck Disability Index		changes from baseline in NDI at 1 month
depression scores on Beck Depression Inventory		changes from baseline in BDI at 1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clinical diagnosis of Whiplash injuries
Must have cervicalgia of more than VAS 5

Exclusion Criteria:

cancer, osteoporosis, ankylosing spodylitis, cauda equina syndrome, infection
spinal operation
other musculoskeletal pain
physicological or mental disorders

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Koh-Woon Kim	Contact	82-10-5101-1075		garson83@hanmail.net

Overall Officials

Name	Affiliation	Role
Seok-Hee Chung	Kyung Hee Oriental Medical Center	Study Chair
Jun-Hwan Lee	Kyung Hee University Hospital at Gangdong	Study Director
Koh-Woon Kim

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014911	Whiplash Injuries

Ancestor Terms

ID	Term
D019838	Neck Injuries
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015670	Acupuncture Therapy
C043940	pyranoprofen

Ancestor Terms

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided