Clinical Trial on the Effectiveness of Traditional Chinese Medicinal Mixture in Parkinson Disease
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Fudan University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Fudan University
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00629161
First received: February 25, 2008
Last updated: May 26, 2010
Last verified: September 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson Disease |
Drug: Traditional Chinese Medicinal Mixture (composed of Roucongrong and adjuvant) Drug: placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Fudan University:
Primary Outcome Measures:
- Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 13 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Hoehn & Yahr scale [ Time Frame: 13 months ] [ Designated as safety issue: No ]
- Schwab & England score [ Time Frame: 13 months ] [ Designated as safety issue: No ]
- The liver kidney deficiency scale score by Traditional Chinese Medicine standard [ Time Frame: 13 months ] [ Designated as safety issue: No ]
- Dose of levodopa per day [ Time Frame: 13 months ] [ Designated as safety issue: No ]
- Dose of dopamine Agonists per day [ Time Frame: 13 months ] [ Designated as safety issue: No ]
- Parkinson disease sleep scale (PDSS) [ Time Frame: 13 months ] [ Designated as safety issue: No ]
- Assessment of autonomic dysfunction in Parkinson disease (SCOPA-AUT) [ Time Frame: 13 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 144 |
| Study Start Date: | November 2008 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: Traditional Chinese Medicinal Mixture (composed of Roucongrong and adjuvant)
12 months period of Traditional Chinese Medicinal Mixture per day plus 1 month wash-out period without herbal medicine
|
| Placebo Comparator: B |
Drug: placebo
12 months period of placebo plus 1 month period without 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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629161
Contacts
| Contact: Dingfang Cai, MD | doctorcn@hotmail.com |
Locations
| China, Beijing | |
| Department of Neurology, Xuanwu hospital, Capital University of Medical Sciences | Recruiting |
| Beijing, Beijing, China, 100053 | |
| Contact: Li Gao, MD | |
| China, Shanghai | |
| Zhongshan hospital, Fudan University | Recruiting |
| Shanghai, Shanghai, China, 200032 | |
| Contact: Dingfang Cai, MD doctorcn@hotmail.com | |
| Department of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting |
| Shanghai, Shanghai, China, 200025 | |
| Contact: Qin Xiao, MD | |
| Department of Neurology, Yueyang Hospital of Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine | Recruiting |
| Shanghai, Shanghai, China, 200437 | |
| Contact: Hong Zhao, MD | |
| Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | Recruiting |
| Shanghai, Shanghai, China, 200032 | |
| Contact: Canxing Yuan, MD | |
| Department of Nuerology, Xinhua Hospital, Affiliated to Shanghai Jiaotong University School of Medicine | Recruiting |
| Shanghai, Shanghai, China, 200127 | |
| Contact: Zhenguo Liu | |
| Tongji Hospital of Tongji University | Recruiting |
| Shanghai, Shanghai, China, 200065 | |
| Contact: Qing Zhan, MD | |
| Shanghai Chinese Medical Hospital | Recruiting |
| Shanghai, Shanghai, China, 200071 | |
| Contact: Yi Liu, MD | |
| The Sixth People＇s Hospital, Shanghai Jiaotong University | Recruiting |
| Shanghai, Shanghai, China, 200233 | |
| Contact: Xiaojiang Sun, MD | |
| China, Zhejiang | |
| Department of Neurology, The second people's hospital of Wenzhou | Recruiting |
| Wenzhou, Zhejiang, China, 325000 | |
| Contact: Liya Han | |
Sponsors and Collaborators
Fudan University
More Information
No publications provided
| Responsible Party: | Dingfang Cai, Zhongshan hospital, Fudan University |
| ClinicalTrials.gov Identifier: | NCT00629161 History of Changes |
| Other Study ID Numbers: | 2006BAI04A11-3 |
| Study First Received: | February 25, 2008 |
| Last Updated: | May 26, 2010 |
| Health Authority: | China: Ministry of Health |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on May 21, 2013