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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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.
  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 ClinicalTrials.gov identifier: 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
Zhongshan hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Dingfang Cai, MD       doctorcn@hotmail.com   
Department of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Qin Xiao, 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         
Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Recruiting
Shanghai, Shanghai, China, 200032
Contact: Canxing Yuan, MD         
Department of Nuerology, Xinhua Hospital, Affiliated to Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200127
Contact: Zhenguo Liu         
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         
The Sixth People's Hospital, Shanghai Jiaotong University Recruiting
Shanghai, Shanghai, China, 200233
Contact: Xiaojiang Sun, 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
  More Information

No publications provided

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

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

ClinicalTrials.gov processed this record on July 26, 2014