Clinical trial NCT00656253: Clinical Trial on the Effectiveness of Herbal Medicinal Mixture in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Parkinson's Disease
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: State Administration of Traditional Chinese Medicine of the People's Republic of China
First posted: 2008-04-11
Enrollment: 158
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Levodopa equivalent dose(LED) per day
timeFrame: 13 months
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: 13 months
measure: Hoehn & Yahr scale
timeFrame: 13 months
measure: Schwab & England score
timeFrame: 13 months
measure: The liver kidney deficiency scale score by Traditional Chinese Medicine standard
timeFrame: 13 months
measure: Parkinson disease sleep scale (PDSS)
timeFrame: 13 months
measure: Assessment of autonomic dysfunction in Parkinson disease (SCOPA-AUT)
timeFrame: 13 months
measure: 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.
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Neurology, Xuanwu hospital, Capital University of Medical Sciences
state: Beijing
city: Shanghai
country: China
facility: Department of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Department of Integrative Medicine, Zhongshan hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Shanghai
country: China
facility: Tongji Hospital of Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Chinese Medical Hospital
state: Shanghai
city: Shanghai
country: China
facility: Department of Nuerology, Xinhua Hospital, Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: The Sixth People's Hospital, Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Department of Neurology, Yueyang Hospital of Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Wenzhou
country: China
facility: Department of Neurology, The second people's hospital of Wenzhou
state: Zhejiang
Study officials:
References: