Efficacy of Acupuncture and Bee Venom Acupuncture on Patients With Idiopathic Parkinson's Disease
1 other identifier
interventional
74
1 country
1
Brief Summary
The aim of this study is to evaluate the efficacy of acupuncture and bee venom acupuncture (BVA) for idiopathic Parkinson's disease (IPD) through a sham-controlled trial and investigate whether there is sustainability of treatments effects by follow-up assessments after the end of the treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2012
Typical duration for not_applicable
1 active site
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
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 17, 2013
CompletedFirst Posted
Study publicly available on registry
October 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedSeptember 9, 2015
September 1, 2015
2.1 years
October 17, 2013
September 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of the Unified Parkinson's Disease Rating Scale (UPDRS) parts II and III
The UPDRS part II is evaluation of the activities of daily living (ADL) and part III is the motor examination.
baseline, up to 12 weeks, 16 weeks, and 20 weeks
Study Arms (3)
Study group
ACTIVE COMPARATORacupuncture and bee venom acupuncture point injection
Control group
SHAM COMPARATORsham acupuncture and normal saline injections
Waiting group
NO INTERVENTIONno additional intervention
Interventions
acupuncture and bee venom acupuncture point injection at 10 acupuncture points twice a week for 12 weeks. This intervention is added on to the conventional antiparkinsonian drugs.
sham acupuncture and normal saline injections at 10 sham acupuncture points twice a week for 12 weeks. This intervention is added on to the conventional antiparkinsonian drugs.
Eligibility Criteria
You may qualify if:
- Patients with IPD who have been on a stable dose of anti-parkinsonian medication for at least one month.
- Hoehn \& Yahr scale I-IV
- More than one point in two or more items (tremor, rigidity, postural instability, and bradykinesia) in the UPDRS Part III, etc.
You may not qualify if:
- Severe psychiatric or organic brain disorders other than PD, previous or current
- Secondary Parkinsonism due to cerebrovascular disease, tumor, infection, etc.
- Atypical Parkinsonian or Parkinson plus syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kyung Hee University Hospital at Gangdong
Seoul, 134-727, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seong-Uk Park, Ph.D
Kyunghee University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
October 17, 2013
First Posted
October 28, 2013
Study Start
October 1, 2012
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
September 9, 2015
Record last verified: 2015-09