Clinical Trial on the Effectiveness of Herbal Medicinal M... | NCT00656253

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

NCT00656253

Sponsor

Fudan University

Status

Completed

Last Update Posted

Mar 22, 2011Estimated

Enrollment

158Actual

Phase

Phase 2Phase 3

Conditions

Parkinson's Disease

Interventions

Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.)
Placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Sep 2010Actual

Completion Date

Feb 2011Actual

First Submitted Date

Apr 7, 2008

First Submission Date that Met QC Criteria

Apr 7, 2008

First Posted Date

Apr 11, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2011

Last Update Posted Date

Mar 22, 2011Estimated

Name	Class
State Administration of Traditional Chinese Medicine of the People's Republic of China	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

158Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental		Drug: Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.)
B	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Levodopa equivalent dose(LED) per day	daily levodopa dose taken by PD patients to control their symptoms.	13 months

Secondary Outcomes

Measure	Description	Time Frame
Unified Parkinson's Disease Rating Scale (UPDRS)		13 months
Hoehn & Yahr scale		13 months
Schwab & England score

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurology, Xuanwu hospital, Capital University of Medical Sciences		Beijing	Beijing Municipality	100053	China

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided