Idiopathic Parkinson's DiseaseNCT01970813
Efficacy of Acupuncture and Bee Venom Acupuncture on Patients With Idiopathic Parkinson's Disease
A study testing acupuncture and bee venom acupuncture point injection in people with Idiopathic Parkinson's Disease, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Idiopathic Parkinson's Disease
- What is being tested?
- acupuncture and bee venom acupuncture point injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2012to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kyung Hee University Hospital at Gangdong
Seoul, 134-727
About this study
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.
Read the detailed description
A total of 90 patients with idiopathic Parkinson's disease (IPD) who have been on a stable dose of anti-parkinsonian medication for at least one month with two or more symptoms among tremor, rigidity, postural instability, and bradykinesia will be included in this study. Participants will be randomly assigned to the study, the control, or the waiting group (2:2:1).
Initial assessment will be performed with the Unified Parkinson's Disease Rating Scale (UPDRS) parts II and III, the Parkinson's Disease Quality of Life Questionnaire (PDQL), the Beck Depression Inventory (BDI), and evaluation of the 20-m walking time and the steps to walk 20-m, as well as postural instability.
Acupuncture and BVA treatments will then be performed on the study group, and sham acupuncture and normal saline injections will be performed on the control group twice a week for 12 weeks. The waiting group does not receive any added treatment during the 12 weeks.
The initial assessment will be repeated after 12 weeks in all groups. In the study and the control groups, an additional assessment will be repeated after 16 and 20 weeks.
- Conditions
- Idiopathic Parkinson's Disease
- Being tested
- acupuncture and bee venom acupuncture point injection, sham acupuncture and normal saline injections
- Keywords
- Parkinson's disease, Idiopathic Parkinson's disease, acupuncture, bee venom acupuncture
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture and bee venom acupuncture point injectionDevice
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 injectionsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | acupuncture and bee venom acupuncture point injection Receives: Device: acupuncture and bee venom acupuncture point injection |
| Control group | Sham comparator | sham acupuncture and normal saline injections Receives: Device: sham acupuncture and normal saline injections |
| Waiting group | No intervention | no additional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, up to 12 weeks, 16 weeks, and 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study startOct 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seong-Uk Park, Kyunghee University Medical Center
- Investigators
- Seong-Uk Park, Ph.D, Principal investigator, Kyunghee University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970813
- Sponsor's protocol ID
- NRF-2011-0021389
- Status last verified
- Sep 2015
- First submitted
- 17 Oct 2013
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acupuncture and Bee Venom Acupuncture on Patients With Idiopathic Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01970813
- Acronym / sponsor ID
- NRF-2011-0021389
- Conditions
- Idiopathic Parkinson's Disease
- Keywords
- Parkinson's disease, Idiopathic Parkinson's disease, acupuncture, bee venom acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 28 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A total of 90 patients with idiopathic Parkinson's disease (IPD) who have been on a stable dose of anti-parkinsonian medication for at least one month with two or more symptoms among tremor, rigidity, postural instability, and bradykinesia will be included in this study. Participants will be randomly assigned to the study, the control, or the waiting group (2:2:1).
Initial assessment will be performed with the Unified Parkinson's Disease Rating Scale (UPDRS) parts II and III, the Parkinson's Disease Quality of Life Questionnaire (PDQL), the Beck Depression Inventory (BDI), and evaluation of the 20-m walking time and the steps to walk 20-m, as well as postural instability.
Acupuncture and BVA treatments will then be performed on the study group, and sham acupuncture and normal saline injections will be performed on the control group twice a week for 12 weeks. The waiting group does not receive any added treatment during the 12 weeks.
The initial assessment will be repeated after 12 weeks in all groups. In the study and the control groups, an additional assessment will be repeated after 16 and 20 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Device: acupuncture and bee venom acupuncture point injectionacupuncture and bee venom acupuncture point injection |
| Control group | Sham comparator | Device: sham acupuncture and normal saline injectionssham acupuncture and normal saline injections |
| Waiting group | No intervention | –no additional intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupuncture and bee venom acupuncture point injectionacupuncture 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. | Device | Study group |
| sham acupuncture and normal saline injectionssham 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. | Device | Control group |
Primary outcome
Change of the Unified Parkinson's Disease Rating Scale (UPDRS) parts II and III
Time frame: baseline, up to 12 weeks, 16 weeks, and 20 weeks
The UPDRS part II is evaluation of the activities of daily living (ADL) and part III is the motor examination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seong-Uk Park, Ph.D principal investigator
Kyunghee University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture and bee venom acupuncture point injection in people with Idiopathic Parkinson's Disease, run by Kyunghee University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the Unified Parkinson's Disease Rating Scale (UPDRS) parts II and III (time frame: baseline, up to 12 weeks, 16 weeks, and 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2015.