Clinical Trial on the Effectiveness of Traditional Chinese Medicinal Mixture in Parkinson Disease
- Conditions
- Parkinson Disease
- Interventions
- Drug: Traditional Chinese Medicinal Mixture (composed of Roucongrong and adjuvant)Drug: placebo
- Registration Number
- NCT00629161
- Lead Sponsor
- Fudan University
- 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. The treatment phase includes 12 months period of Traditional Chinese Medicinal Mixture per day or placebo and 1 month wash-out period without herbal medicine and placebo.
- 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.
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 Traditional Chinese Medicinal Mixture improves the overall wellbeing of PD patients and thus may leads to an improvement of parkinsonian symptoms in PD patients.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 144
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Traditional Chinese Medicinal Mixture (composed of Roucongrong and adjuvant) - B placebo -
- Primary Outcome Measures
Name Time Method Unified Parkinson's Disease Rating Scale (UPDRS) 13 months
- Secondary Outcome Measures
Name Time Method Hoehn & Yahr scale 13 months Schwab & England score 13 months Parkinson disease sleep scale (PDSS) 13 months The liver kidney deficiency scale score by Traditional Chinese Medicine standard 13 months Dose of levodopa per day 13 months Dose of dopamine Agonists per day 13 months Assessment of autonomic dysfunction in Parkinson disease (SCOPA-AUT) 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. 12 months
Trial Locations
- Locations (10)
Department of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Zhongshan hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
Department of Neurology, Xuanwu hospital, Capital University of Medical Sciences
🇨🇳Beijing, Beijing, China
Department of Nuerology, Xinhua Hospital, Affiliated to Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Shanghai Chinese Medical Hospital
🇨🇳Shanghai, Shanghai, China
Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, Shanghai, China
Tongji Hospital of Tongji University
🇨🇳Shanghai, Shanghai, China
Department of Neurology, The second people's hospital of Wenzhou
🇨🇳Wenzhou, Zhejiang, China
Department of Neurology, Yueyang Hospital of Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, Shanghai, China
The Sixth People's Hospital, Shanghai Jiaotong University
🇨🇳Shanghai, Shanghai, China