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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
Information provided by:
Fudan University Identifier:
First received: February 25, 2008
Last updated: May 26, 2010
Last verified: September 2009
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 Intervention Phase
Parkinson Disease
Drug: Traditional Chinese Medicinal Mixture (composed of Roucongrong and adjuvant)
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Fudan University:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 144
Study Start Date: November 2008
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00629161

China, Beijing
Department of Neurology, Xuanwu hospital, Capital University of Medical Sciences
Beijing, Beijing, China, 100053
China, Shanghai
Department of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China, 200025
Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai, China, 200032
Zhongshan hospital, Fudan University
Shanghai, Shanghai, China, 200032
Tongji Hospital of Tongji University
Shanghai, Shanghai, China, 200065
Shanghai Chinese Medical Hospital
Shanghai, Shanghai, China, 200071
Department of Nuerology, Xinhua Hospital, Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai, China, 200127
The Sixth People's Hospital, Shanghai Jiaotong University
Shanghai, Shanghai, China, 200233
Department of Neurology, Yueyang Hospital of Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai, China, 200437
China, Zhejiang
Department of Neurology, The second people's hospital of Wenzhou
Wenzhou, Zhejiang, China, 325000
Sponsors and Collaborators
Fudan University
  More Information

Responsible Party: Dingfang Cai, Zhongshan hospital, Fudan University Identifier: NCT00629161     History of Changes
Other Study ID Numbers: 2006BAI04A11-3 
Study First Received: February 25, 2008
Last Updated: May 26, 2010

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases processed this record on February 20, 2017