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

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Collaborators: China's Ministry of Health; Administration of Traditional Chinese Medicine (SATCM); State Administration of Traditional Chinese Medicine of the People's Republic of China

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.