Clinical Trial on the Effectiveness of Herbal Medicinal Mixture in Parkinson Disease
NCT ID: NCT00656253
Last Updated: 2011-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
158 participants
INTERVENTIONAL
2008-08-31
2011-02-28
Brief Summary
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Detailed Description
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The design of the study was a prospective, randomized, multicenter, double-blind placebo-controlled protocol. The intervention includes Herbal Medicinal Mixture Bid or matched placebo for 12 months plus 1 month wash-out period.
Participating study centers include Neurological University Outpatient Clinics and Neurological Departments of Community-based Hospitals experienced with PD patients.
The primary outcome measure was the combined Unified Parkinson's Disease Rating Scale (UPDRS).
The hypothesis of this study was that Herbal Medicinal Mixture improves the overall wellbeing of PD patients and thus may leads to an improvement of parkinsonian symptoms in PD patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.)
12 months period of Herbal Medicinal Mixture per day plus 1 month wash-out period without herbal medicine
B
Placebo
12 months period of placebo plus 1 month period without placebo
Interventions
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Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.)
12 months period of Herbal Medicinal Mixture per day plus 1 month wash-out period without herbal medicine
Placebo
12 months period of placebo plus 1 month period without placebo
Eligibility Criteria
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Inclusion 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 Criteria
* 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.
50 Years
ALL
No
Sponsors
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State Administration of Traditional Chinese Medicine of the People's Republic of China
OTHER_GOV
Fudan University
OTHER
Responsible Party
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Zhongshan hospital of Fudan University
Locations
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Department of Neurology, Xuanwu hospital, Capital University of Medical Sciences
Beijing, Beijing Municipality, China
Department of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Department of Integrative Medicine, Zhongshan hospital, Fudan University
Shanghai, Shanghai Municipality, China
Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, China
Shanghai Chinese Medical Hospital
Shanghai, Shanghai Municipality, China
Department of Nuerology, Xinhua Hospital, Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
The Sixth People's Hospital, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Department of Neurology, Yueyang Hospital of Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Department of Neurology, The second people's hospital of Wenzhou
Wenzhou, Zhejiang, China
Countries
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Other Identifiers
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2006BAI04A11
Identifier Type: -
Identifier Source: org_study_id
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