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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.)
Placebo
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Department of Neurology, Xuanwu hospital, Capital University of Medical Sciences
  • Department of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
  • Department of Integrative Medicine, Zhongshan hospital, Fudan University
  • Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
  • Tongji Hospital of Tongji University
  • Shanghai Chinese Medical Hospital
  • Department of Nuerology, Xinhua Hospital, Affiliated to Shanghai Jiaotong University School of Medicine
  • The Sixth People's Hospital, Shanghai Jiaotong University
  • Department of Neurology, Yueyang Hospital of Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
  • Department of Neurology, The second people's hospital of Wenzhou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Levodopa equivalent dose(LED) per day
daily levodopa dose taken by PD patients to control their symptoms.

Secondary Outcome Measures

Unified Parkinson's Disease Rating Scale (UPDRS)
Hoehn & Yahr scale
Schwab & England score
The liver kidney deficiency scale score by Traditional Chinese Medicine standard
Parkinson disease sleep scale (PDSS)
Assessment of autonomic dysfunction in Parkinson disease (SCOPA-AUT)
Changes in laboratory indexes as safety assessment, including red blood cell(RBC), white blood cell(WBC), platelet(PLT), alanine transaminase (ALT), aspartate transaminase (AST), blood urea nitrogen (BUN), creatinine(Cr) in blood samples, ect.

Full Information

First Posted
April 7, 2008
Last Updated
March 21, 2011
Sponsor
Fudan University
Collaborators
State Administration of Traditional Chinese Medicine of the People's Republic of China
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1. Study Identification

Unique Protocol Identification Number
NCT00656253
Brief Title
Clinical Trial on the Effectiveness of Herbal Medicinal Mixture in Parkinson Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fudan University
Collaborators
State Administration of Traditional Chinese Medicine of the People's Republic of China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.)
Intervention Description
12 months period of Herbal Medicinal Mixture per day plus 1 month wash-out period without herbal medicine
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
12 months period of placebo plus 1 month period without placebo
Primary Outcome Measure Information:
Title
Levodopa equivalent dose(LED) per day
Description
daily levodopa dose taken by PD patients to control their symptoms.
Time Frame
13 months
Secondary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale (UPDRS)
Time Frame
13 months
Title
Hoehn & Yahr scale
Time Frame
13 months
Title
Schwab & England score
Time Frame
13 months
Title
The liver kidney deficiency scale score by Traditional Chinese Medicine standard
Time Frame
13 months
Title
Parkinson disease sleep scale (PDSS)
Time Frame
13 months
Title
Assessment of autonomic dysfunction in Parkinson disease (SCOPA-AUT)
Time Frame
13 months
Title
Changes in laboratory indexes as safety assessment, including red blood cell(RBC), white blood cell(WBC), platelet(PLT), alanine transaminase (ALT), aspartate transaminase (AST), blood urea nitrogen (BUN), creatinine(Cr) in blood samples, ect.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Department of Neurology, Xuanwu hospital, Capital University of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
Department of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Department of Integrative Medicine, Zhongshan hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Tongji Hospital of Tongji University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200065
Country
China
Facility Name
Shanghai Chinese Medical Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200071
Country
China
Facility Name
Department of Nuerology, Xinhua Hospital, Affiliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
The Sixth People's Hospital, Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China
Facility Name
Department of Neurology, Yueyang Hospital of Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200437
Country
China
Facility Name
Department of Neurology, The second people's hospital of Wenzhou
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China

12. IPD Sharing Statement

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

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