Status:
UNKNOWN
Clinical Trial on the Effectiveness of Traditional Chinese Medicinal Mixture in Parkinson Disease
Lead Sponsor:
Fudan University
Conditions:
Parkinson Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE2
PHASE3
Brief Summary
This study was designed to evaluate the symptomatic effects or potential disease progression slowing down effect of a kind of Traditional Chinese Medicinal Mixture in Parkinson's disease (PD) patients...
Detailed Description
The design of the study was a prospective, randomized, multicenter, double-blind placebo-controlled protocol. The intervention includes Traditional Chinese Medicinal Mixture tid or matched placebo. P...
Eligibility Criteria
Inclusion
- Parkinson's disease according to the UK Brain Bank criteria
- Hoehn \& Yahr stadium Ⅰ～Ⅲ
- Age over 50 years
- Taking only levodopa and/or dopamine agonists when recruiting
- Consistent with the liver kidney deficiency type by Traditional Chinese Medicine (TCM) standard
- Patients voluntarily take part in this study and signed the informed consent
Exclusion
- Modified Hoehn-Yahr scale are higher than 4
- Had other serious illness such as liver/kidney failure, serious infection etc
- Allergic to the study drug
- Had been participated in other clinical trials during the last 3 months prior to study inclusion.
- Taking Coenzyme Q10, MAO-B inhibitors, or vitamin E, all of which might improve the symptom or slowdown the progression of PD.
- Taking herbal medicine that can nourish the liver and kidney by TCM standard.
- Had serious mental disorder and could not describe his/her symptom.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT00629161
Start Date
November 1 2008
Last Update
May 28 2010
Active Locations (10)
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1
Department of Neurology, Xuanwu hospital, Capital University of Medical Sciences
Beijing, Beijing Municipality, China, 100053
2
Department of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
3
Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China, 200032
4
Zhongshan hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032