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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional Chinese Medicinal Mixture (composed of Roucongrong and adjuvant) | Drug | 12 months period of Traditional Chinese Medicinal Mixture per day plus 1 month wash-out period without herbal medicine |
| Measure | Description | Time Frame |
|---|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) | 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hoehn & Yahr scale | 13 months | |
| Schwab & England score | 13 months | |
| The liver kidney deficiency scale score by Traditional Chinese Medicine standard |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dingfang Cai, MD | Contact | doctorcn@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, Xuanwu hospital, Capital University of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100053 | China |
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| placebo | Drug | 12 months period of placebo plus 1 month period without placebo |
|
| 13 months |
| Dose of levodopa per day | 13 months |
| Dose of dopamine Agonists per day | 13 months |
| Parkinson disease sleep scale (PDSS) | 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 |
| Department of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
|
| Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| Zhongshan hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| Tongji Hospital of Tongji University | Recruiting | Shanghai | Shanghai Municipality | 200065 | China |
|
| Shanghai Chinese Medical Hospital | Recruiting | Shanghai | Shanghai Municipality | 200071 | China |
|
| Department of Nuerology, Xinhua Hospital, Affiliated to Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
|
| The Sixth People's Hospital, Shanghai Jiaotong University | Recruiting | Shanghai | Shanghai Municipality | 200233 | China |
|
| Department of Neurology, Yueyang Hospital of Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine | Recruiting | Shanghai | Shanghai Municipality | 200437 | China |
|
| Department of Neurology, The second people's hospital of Wenzhou | Recruiting | Wenzhou | Zhejiang | 325000 | China |
|
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D000277 | Adjuvants, Pharmaceutic |
| ID | Term |
|---|---|
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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