Parkinson Disease
Conditions
Brief 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.
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.
Interventions
DRUGTraditional 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
DRUGplacebo
12 months period of placebo plus 1 month period without placebo
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) | 13 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Hoehn & Yahr scale | 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 |
| Dose of dopamine Agonists per day | 13 months |
Countries
China
Contacts
Primary ContactDingfang Cai, MD
Outcome results
None listed