Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2026-02-24 @ 11:00 AM
Study NCT ID:
NCT00629161
Status:
UNKNOWN
Last Update Posted:
2010-05-28
First Post:
2008-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial on the Effectiveness of Traditional Chinese Medicinal Mixture in Parkinson Disease
Sponsor:
Fudan University
Organization:
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2009-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was designed to evaluate the symptomatic effects or potential disease progression slowing down effect of a kind of Traditional Chinese Medicinal Mixture in Parkinson's disease (PD) patients. The treatment phase includes 12 months period of Traditional Chinese Medicinal Mixture per day or placebo and 1 month wash-out period without herbal medicine and placebo.
Detailed Description:
The design of the study was a prospective, randomized, multicenter, double-blind placebo-controlled protocol. The intervention includes Traditional Chinese Medicinal Mixture tid or matched placebo.
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 Traditional Chinese Medicinal Mixture improves the overall wellbeing of PD patients and thus may leads to an improvement of parkinsonian symptoms in PD patients.
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 Traditional Chinese Medicinal Mixture improves the overall wellbeing of PD patients and thus may leads to an improvement of parkinsonian symptoms in PD patients.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: