Parkinson's Disease
Conditions
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.
Interventions
DRUGHerbal Medicinal Mixture (Roucongrong, Heshouwu etc.)
12 months period of Herbal 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
State Administration of Traditional Chinese Medicine of the People's Republic of China
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 | Description |
|---|---|---|
| Levodopa equivalent dose(LED) per day | 13 months | daily levodopa dose taken by PD patients to control their symptoms. |
Secondary
| 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 |
| Unified Parkinson's Disease Rating Scale (UPDRS) | 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 |
| Parkinson disease sleep scale (PDSS) | 13 months |
Countries
China
Outcome results
None listed