Clinical Trial on the Effectiveness of Herbal Medicinal Mixture in Parkinson Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 10
- 主要终点
- Levodopa equivalent dose(LED) per day
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
A
干预措施: Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.) (Drug)
B
干预措施: Placebo (Drug)
结局指标
主要结局
Levodopa equivalent dose(LED) per day
时间窗: 13 months
daily levodopa dose taken by PD patients to control their symptoms.
次要结局
- Unified Parkinson's Disease Rating Scale (UPDRS)(13 months)
- Hoehn & Yahr scale(13 months)
- Schwab & England score(13 months)
- The liver kidney deficiency scale score by Traditional Chinese Medicine standard(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)