NCT00629161

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for phase_2 parkinson-disease

Geographic Reach
1 country

10 active sites

Status
unknown

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

February 25, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Last Updated

May 28, 2010

Status Verified

September 1, 2009

Enrollment Period

1.7 years

First QC Date

February 25, 2008

Last Update Submit

May 26, 2010

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Unified Parkinson's Disease Rating Scale (UPDRS)

    13 months

Secondary Outcomes (8)

  • Hoehn & Yahr scale

    13 months

  • Schwab & England score

    13 months

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

    13 months

  • Dose of levodopa per day

    13 months

  • Dose of dopamine Agonists per day

    13 months

  • +3 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL
Drug: Traditional Chinese Medicinal Mixture (composed of Roucongrong and adjuvant)

B

PLACEBO COMPARATOR
Drug: placebo

Interventions

Traditional Chinese Medicinal Mixture (composed of Roucongrong and adjuvant)DRUG

12 months period of Traditional Chinese 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

RECRUITING

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

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

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

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Zhongshan hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Tongji Hospital of Tongji University

Shanghai, Shanghai Municipality, 200065, China

RECRUITING

Shanghai Chinese Medical Hospital

Shanghai, Shanghai Municipality, 200071, China

RECRUITING

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

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

The Sixth People's Hospital, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200233, China

RECRUITING

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

Shanghai, Shanghai Municipality, 200437, China

RECRUITING

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

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Adjuvants, Pharmaceutic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pharmaceutic AidsPharmaceutical PreparationsSpecialty Uses of ChemicalsChemical Actions and Uses

Central Study Contacts

Dingfang Cai, MD

CONTACT

doctorcn@hotmail.com

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

February 25, 2008

First Posted

March 5, 2008

Study Start

November 1, 2008

Primary Completion

August 1, 2010

Last Updated

May 28, 2010

Record last verified: 2009-09

Locations

CN(10)