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

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.
ClinicalTrials.gov Identifier: NCT00629161
Recruitment Status : Unknown
Verified September 2009 by Fudan University.
Recruitment status was:  Recruiting
First Posted : March 5, 2008
Last Update Posted : May 28, 2010
Sponsor:
Information provided by:
Fudan University

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Traditional Chinese Medicinal Mixture (composed of Roucongrong and adjuvant) Drug: placebo Phase 2 Phase 3

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : November 2008
Estimated Primary Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A 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
Placebo Comparator: B Drug: placebo
12 months period of placebo plus 1 month period without placebo



Primary Outcome Measures :
  1. Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 13 months ]

Secondary Outcome Measures :
  1. Hoehn & Yahr scale [ Time Frame: 13 months ]
  2. Schwab & England score [ Time Frame: 13 months ]
  3. The liver kidney deficiency scale score by Traditional Chinese Medicine standard [ Time Frame: 13 months ]
  4. Dose of levodopa per day [ Time Frame: 13 months ]
  5. Dose of dopamine Agonists per day [ Time Frame: 13 months ]
  6. Parkinson disease sleep scale (PDSS) [ Time Frame: 13 months ]
  7. Assessment of autonomic dysfunction in Parkinson disease (SCOPA-AUT) [ Time Frame: 13 months ]
  8. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00629161


Contacts
Contact: Dingfang Cai, MD doctorcn@hotmail.com

Locations
China, Beijing
Department of Neurology, Xuanwu hospital, Capital University of Medical Sciences Recruiting
Beijing, Beijing, China, 100053
Contact: Li Gao, MD         
China, Shanghai
Department of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Qin Xiao, MD         
Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Recruiting
Shanghai, Shanghai, China, 200032
Contact: Canxing Yuan, MD         
Zhongshan hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Dingfang Cai, MD       doctorcn@hotmail.com   
Tongji Hospital of Tongji University Recruiting
Shanghai, Shanghai, China, 200065
Contact: Qing Zhan, MD         
Shanghai Chinese Medical Hospital Recruiting
Shanghai, Shanghai, China, 200071
Contact: Yi Liu, MD         
Department of Nuerology, Xinhua Hospital, Affiliated to Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200127
Contact: Zhenguo Liu         
The Sixth People's Hospital, Shanghai Jiaotong University Recruiting
Shanghai, Shanghai, China, 200233
Contact: Xiaojiang Sun, MD         
Department of Neurology, Yueyang Hospital of Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine Recruiting
Shanghai, Shanghai, China, 200437
Contact: Hong Zhao, MD         
China, Zhejiang
Department of Neurology, The second people's hospital of Wenzhou Recruiting
Wenzhou, Zhejiang, China, 325000
Contact: Liya Han         
Sponsors and Collaborators
Fudan University

Responsible Party: Dingfang Cai, Zhongshan hospital, Fudan University
ClinicalTrials.gov Identifier: NCT00629161     History of Changes
Other Study ID Numbers: 2006BAI04A11-3
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: May 28, 2010
Last Verified: September 2009

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases