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

This study has been completed.
Sponsor:
Collaborator:
China's Ministry of Health; Administration of Traditional Chinese Medicine (SATCM)
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00656253
First received: April 7, 2008
Last updated: March 21, 2011
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 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
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:
  • Levodopa equivalent dose(LED) per day [ Time Frame: 13 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ]
  • 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 ]

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

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: NCT00656253

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

No publications provided

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
Study First Received: April 7, 2008
Last Updated: March 21, 2011
Health Authority: China: Ethics Committee

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 22, 2014