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

Fudan University

Status and phase

Completed

Phase 3

Phase 2

Conditions

Parkinson's Disease

Treatments

Drug: Placebo

Drug: Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.)

Study type

Interventional

Funder types

Other

Identifiers

NCT00656253

2006BAI04A11

Details and patient eligibility

About

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.

Full description

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.

Enrollment

158 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.