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

Parkinson Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00629161
• Other study ID #: 2006BAI04A11-3
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: February 25, 2008
• Last updated: May 26, 2010
• Start date: November 2008

Study information

• Verified date: September 2009
• Source: Fudan University
• Contact: Dingfang Cai, MD
• Email: doctorcn[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Parkinson's disease according to the UK Brain Bank criteria

• Hoehn & Yahr stadium ?~?

• 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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
12 months period of placebo plus 1 month period without placebo

Locations

Country	Name	City	State
China	Department of Neurology, Xuanwu hospital, Capital University of Medical Sciences	Beijing	Beijing
China	Department of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Department of Neurology, Yueyang Hospital of Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai
China	Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai
China	Department of Nuerology, Xinhua Hospital, Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Shanghai Chinese Medical Hospital	Shanghai	Shanghai
China	The Sixth People's Hospital, Shanghai Jiaotong University	Shanghai	Shanghai
China	Tongji Hospital of Tongji University	Shanghai	Shanghai
China	Zhongshan hospital, Fudan University	Shanghai	Shanghai
China	Department of Neurology, The second people's hospital of Wenzhou	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unified Parkinson's Disease Rating Scale (UPDRS)		13 months	No
Secondary	Hoehn & Yahr scale		13 months	No
Secondary	Schwab & England score		13 months	No
Secondary	The liver kidney deficiency scale score by Traditional Chinese Medicine standard		13 months	No
Secondary	Dose of levodopa per day		13 months	No
Secondary	Dose of dopamine Agonists per day		13 months	No
Secondary	Parkinson disease sleep scale (PDSS)		13 months	No
Secondary	Assessment of autonomic dysfunction in Parkinson disease (SCOPA-AUT)		13 months	No
Secondary	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	Yes