Clinical Trial on the Effectiveness of Herbal Medicinal Mixture in Parkinson Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.)<br>* 12 months period of Herbal Medicinal Mixture per day plus 1 month wash-out period without herbal medicine<br>|
| Placebo Comparator: B<br> | Drug: Placebo<br>* 12 months period of placebo plus 1 month period without placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levodopa equivalent dose(LED) per day | daily levodopa dose taken by PD patients to control their symptoms. | 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Parkinson's Disease Rating Scale (UPDRS) |  | 13 months | 
| Hoehn & Yahr scale |  | 13 months | 
| Schwab & England score |  | 13 months | 
| The liver kidney deficiency scale score by Traditional Chinese Medicine standard |  | 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 |