Trial | NCT00656253  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    roucongrong heshouwu ...

  • Study Participants

    158
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.
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 Started
Aug 31
2008
Primary Completion
Sep 30
2010
Study Completion
Feb 28
2011
Last Update
Mar 22
2011
Estimate

Drug Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.)

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

Drug Placebo

12 months period of placebo plus 1 month period without placebo

A Experimental

B Placebo Comparator

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.
No Results Posted