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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by Fudan University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00629161
First Posted: March 5, 2008
Last Update Posted: May 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Fudan University
February 25, 2008
March 5, 2008
May 28, 2010
November 2008
August 2010   (Final data collection date for primary outcome measure)
Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 13 months ]
Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 12 months ]
Complete list of historical versions of study NCT00629161 on ClinicalTrials.gov Archive Site
  • Hoehn & Yahr scale [ Time Frame: 13 months ]
  • Schwab & England score [ Time Frame: 13 months ]
  • The liver kidney deficiency scale score by Traditional Chinese Medicine standard [ Time Frame: 13 months ]
  • Dose of levodopa per day [ Time Frame: 13 months ]
  • Dose of dopamine Agonists per day [ Time Frame: 13 months ]
  • Parkinson disease sleep scale (PDSS) [ Time Frame: 13 months ]
  • Assessment of autonomic dysfunction in Parkinson disease (SCOPA-AUT) [ Time Frame: 13 months ]
  • 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 ]
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Clinical Trial on the Effectiveness of Traditional Chinese Medicinal Mixture in Parkinson Disease
Not Provided
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
 
Unknown status
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.
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00629161
2006BAI04A11-3
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Dingfang Cai, Zhongshan hospital, Fudan University
Fudan University
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Fudan University
September 2009

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