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

Fudan University158 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

158

Conditions

Parkinson's Disease

Interventions

Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.)DRUG

12 months period of Herbal Medicinal Mixture per day plus 1 month wash-out period without herbal medicine

PlaceboDRUG

12 months period of placebo plus 1 month period without placebo

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (10)

Department of Neurology, Xuanwu hospital, Capital University of Medical Sciences

Beijing, Beijing Municipality, China

Department of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Levodopa equivalent dose(LED) per day

daily levodopa dose taken by PD patients to control their symptoms.

Time frame: 13 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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