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Clinical Trial on the Effectiveness of Herbal Medicinal Mixture in Parkinson Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00656253
First Posted: April 11, 2008
Last Update Posted: March 22, 2011
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.
Collaborator:
China's Ministry of Health; Administration of Traditional Chinese Medicine (SATCM)
Information provided by:
Fudan University
  Purpose
This study was designed to evaluate the symptomatic effects or potential disease progression slowing down effect of a kind of Herbal Medicinal Mixture in Parkinson's disease (PD) patients. The treatment phase includes 12 months period of Herbal Medicinal Mixture per day or placebo and 1 month wash-out period without herbal medicine and placebo.

Condition Intervention Phase
Parkinson's Disease Drug: Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.) Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Levodopa equivalent dose(LED) per day [ Time Frame: 13 months ]
    daily levodopa dose taken by PD patients to control their symptoms.


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

Enrollment: 158
Study Start Date: August 2008
Study Completion Date: February 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.)
12 months period of Herbal 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:

This study was designed to evaluate the symptomatic effects or potential disease progression slowing down effect of a kind of Herbal Medicinal Mixture in Parkinson's disease (PD) patients. The treatment phase includes 12 months period of Herbal 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 Herbal Medicinal Mixture Bid or matched placebo for 12 months plus 1 month wash-out period.

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 Herbal Medicinal Mixture improves the overall wellbeing of PD patients and thus may leads to an improvement of parkinsonian symptoms in PD patients.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
  Contacts and Locations
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): NCT00656253


Locations
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 Integrative Medicine, Zhongshan hospital, Fudan University
Shanghai, Shanghai, China, 200032
Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
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
China's Ministry of Health; Administration of Traditional Chinese Medicine (SATCM)
  More Information

Responsible Party: Department of Integrative Medicine, Zhongshan hospital, Zhongshan hospital of Fudan University
ClinicalTrials.gov Identifier: NCT00656253     History of Changes
Other Study ID Numbers: 2006BAI04A11
First Submitted: April 7, 2008
First Posted: April 11, 2008
Last Update Posted: March 22, 2011
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