Clinical Trial on the Effectiveness of Traditional Chinese Medicinal Mixture in Parkinson Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00629161
First received: February 25, 2008
Last updated: May 26, 2010
Last verified: September 2009

February 25, 2008
May 26, 2010
November 2008
August 2010   (final data collection date for primary outcome measure)
Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 13 months ] [ Designated as safety issue: No ]
Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00629161 on ClinicalTrials.gov Archive Site
  • Hoehn & Yahr scale [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • Schwab & England score [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • The liver kidney deficiency scale score by Traditional Chinese Medicine standard [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • Dose of levodopa per day [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • Dose of dopamine Agonists per day [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • Parkinson disease sleep scale (PDSS) [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • Assessment of autonomic dysfunction in Parkinson disease (SCOPA-AUT) [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
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Clinical Trial on the Effectiveness of Traditional Chinese Medicinal Mixture in Parkinson Disease
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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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson Disease
  • Drug: Traditional Chinese Medicinal Mixture (composed of Roucongrong and adjuvant)
    12 months period of Traditional Chinese Medicinal Mixture per day plus 1 month wash-out period without herbal medicine
  • Drug: placebo
    12 months period of placebo plus 1 month period without placebo
  • Experimental: A
    Intervention: Drug: Traditional Chinese Medicinal Mixture (composed of Roucongrong and adjuvant)
  • Placebo Comparator: B
    Intervention: Drug: placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
144
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August 2010   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact: Dingfang Cai, MD doctorcn@hotmail.com
China
 
NCT00629161
2006BAI04A11-3
Not Provided
Dingfang Cai, Zhongshan hospital, Fudan University
Fudan University
Not Provided
Not Provided
Fudan University
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP