Clinical Trial on the Effectiveness of Herbal Medicinal Mixture in Parkinson Disease
|Parkinson's Disease||Drug: Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.) Drug: Placebo||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
- Levodopa equivalent dose(LED) per day [ Time Frame: 13 months ]daily levodopa dose taken by PD patients to control their symptoms.
- Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 13 months ]
- Hoehn & Yahr scale [ Time Frame: 13 months ]
- Schwab & England score [ Time Frame: 13 months ]
- The liver kidney deficiency scale score by Traditional Chinese Medicine standard [ Time Frame: 13 months ]
- Parkinson disease sleep scale (PDSS) [ Time Frame: 13 months ]
- Assessment of autonomic dysfunction in Parkinson disease (SCOPA-AUT) [ Time Frame: 13 months ]
- Changes in laboratory indexes as safety assessment, including red blood cell(RBC), white blood cell(WBC), platelet(PLT), alanine transaminase (ALT), aspartate transaminase (AST), blood urea nitrogen (BUN), creatinine(Cr) in blood samples, ect. [ Time Frame: 12 months ]
|Study Start Date:||August 2008|
|Study Completion Date:||February 2011|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Drug: 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 Comparator: B||
12 months period of placebo plus 1 month period without placebo
This study was designed to evaluate the symptomatic effects or potential disease progression slowing down effect of a kind of Herbal Medicinal Mixture in Parkinson's disease (PD) patients. The treatment phase includes 12 months period of Herbal Medicinal Mixture per day or placebo and 1 month wash-out period without herbal medicine and placebo.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00656253
|Department of Neurology, Xuanwu hospital, Capital University of Medical Sciences|
|Beijing, Beijing, China, 100053|
|Department of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine|
|Shanghai, Shanghai, China, 200025|
|Department of Integrative Medicine, Zhongshan hospital, Fudan University|
|Shanghai, Shanghai, China, 200032|
|Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine|
|Shanghai, Shanghai, China, 200032|
|Tongji Hospital of Tongji University|
|Shanghai, Shanghai, China, 200065|
|Shanghai Chinese Medical Hospital|
|Shanghai, Shanghai, China, 200071|
|Department of Nuerology, Xinhua Hospital, Affiliated to Shanghai Jiaotong University School of Medicine|
|Shanghai, Shanghai, China, 200127|
|The Sixth People＇s Hospital, Shanghai Jiaotong University|
|Shanghai, Shanghai, China, 200233|
|Department of Neurology, Yueyang Hospital of Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine|
|Shanghai, Shanghai, China, 200437|
|Department of Neurology, The second people's hospital of Wenzhou|
|Wenzhou, Zhejiang, China, 325000|