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

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.

Study Overview

• Status: Unknown
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: Traditional Chinese Medicinal Mixture (composed of Roucongrong and adjuvant); Drug: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Dingfang Cai, MD; Email: doctorcn@hotmail.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Unified Parkinson's Disease Rating Scale (UPDRS)	13 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Hoehn & Yahr scale	13 months
Schwab & England score	13 months
The liver kidney deficiency scale score by Traditional Chinese Medicine standard	13 months
Dose of levodopa per day	13 months
Dose of dopamine Agonists per day	13 months
Parkinson disease sleep scale (PDSS)	13 months
Assessment of autonomic dysfunction in Parkinson disease (SCOPA-AUT)	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.	12 months

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Anticipated): August 1, 2010

Study Registration Dates

• First Submitted: February 25, 2008
• First Submitted That Met QC Criteria: February 25, 2008
• First Posted (Estimate): March 5, 2008

Study Record Updates

• Last Update Posted (Estimate): May 28, 2010
• Last Update Submitted That Met QC Criteria: May 26, 2010
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 2006BAI04A11-3