NCT00656253

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

March 22, 2011

Status Verified

September 1, 2009

Enrollment Period

2.1 years

First QC Date

April 7, 2008

Last Update Submit

March 21, 2011

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Levodopa equivalent dose(LED) per day

    daily levodopa dose taken by PD patients to control their symptoms.

    13 months

Secondary Outcomes (7)

  • Unified Parkinson's Disease Rating Scale (UPDRS)

    13 months

  • Hoehn & Yahr scale

    13 months

  • Schwab & England score

    13 months

  • The liver kidney deficiency scale score by Traditional Chinese Medicine standard

    13 months

  • Parkinson disease sleep scale (PDSS)

    13 months

  • +2 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL
Drug: Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.)

B

PLACEBO COMPARATOR
Drug: Placebo

Interventions

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
PlaceboDRUG

12 months period of placebo plus 1 month period without placebo

B

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Department of Neurology, Xuanwu hospital, Capital University of Medical Sciences

Beijing, Beijing Municipality, 100053, China

Location

Department of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Department of Integrative Medicine, Zhongshan hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200032, China

Location

Tongji Hospital of Tongji University

Shanghai, Shanghai Municipality, 200065, China

Location

Shanghai Chinese Medical Hospital

Shanghai, Shanghai Municipality, 200071, China

Location

Department of Nuerology, Xinhua Hospital, Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

The Sixth People's Hospital, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200233, China

Location

Department of Neurology, Yueyang Hospital of Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200437, China

Location

Department of Neurology, The second people's hospital of Wenzhou

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2008

First Posted

April 11, 2008

Study Start

August 1, 2008

Primary Completion

September 1, 2010

Study Completion

February 1, 2011

Last Updated

March 22, 2011

Record last verified: 2009-09

Locations

CN(10)