A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study of the Prevention of Levodopa-Induced Dyskinesia With Tianqi Pingchan Granule
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- new dyskinesia attack
研究概览
简要总结
A randomized, double-blind, placebo-controlled multicenter clinical trial was used to observe the effectiveness, safety and side effects of Tianqi Pingzhan Granule in the prevention of levodopa induced dyskinesia, so as to determine the clinical efficacy of Tianqi Pingzhan Granule in the prevention of levodopa induced dyskinesia.
详细描述
The aim of this clinical trail is to evaluate the effect of Tianqi Pingzhan Granule in the prevention of levodopa induced dyskinesia in adults. All patients included in the study should meet the inclusion criteria. Half of participants will receive Tianqi Pingzhan Granule, while the other half will receive a placebo of Tianqi Pingzhan Granule. All participants will be assigned to either the active group or the control group randomly. During the clinical trail both doctors and patients are double-blind except serious adverse events occurred.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with PD aged 30-85，have at least the following two conditions:
- •Dosage of Levodopa ≥ 400mg/d;
- •Grade of H&Y≥3;
- •risk score of dyskinesia>4;
排除标准
- •PD patients with dyskinesia;
- •Taking other Chinese medicines against Parkinson's disease;
- •pregnant and lactating women;
- •Impaired cognitive function (according to pre-entry MMSE score):
- •secondary education level: MMSE <24 points; primary education level <20 points; illiterate <17 points;
- •accompanied by a history of mental illness;
- •impaired liver and kidney function;
- •accompanied by severe other systemic diseases;
- •Previous traditional Chinese medicine preparations or serious adverse reactions
- •Before the enrollment, the EKG showed obvious abnormalities and required clinical intervention.
- •PD related brain surgery
- •Patients who are participating in other clinical studies or has participated other clinical studies within 30 days before
- •Patients unable to cooperate with the survey
研究组 & 干预措施
Tianqi Pingchan Granule group
Tianqi Pingchan Granule were manufactured according to Good Manufacturing Practice (GMP) by Sichuan Neo-Green Pharmaceutical Technology Development Co., Ltd. , granule, twice a day, for six months.
干预措施: Tianqi Pingchan Granule (Drug)
Tianqi Pingchan Granule Placebo group
placebo, granule, twice a day, for six months.
干预措施: Tianqi Pingchan Granule Placebo (Drug)
结局指标
主要结局
new dyskinesia attack
时间窗: 48 weeks
The occurrence of Levodopa-Induced dyskinesia
次要结局
- HAMA (Hamilton Anxiety Scale)(48 weeks)
- HAMD-24(Hamilton Depression Scale-24)(48 weeks)
- ESS （Epwroth Sleepiness Scale）(48 weeks)
- SCOP-AUT(scale for outcomes in Parkinson's disease for autonomic symptoms)(48 weeks)
- Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(48 weeks)
- PD-ADL（Parkinson's disease-Activity of Daily Living Scale）(48 weeks)
- Patient diaries(48 weeks)
- PDSS （Parkinson's Disease Sleep Scale）(48 weeks)
- MMSE（Mini-Mental State Examination）(48 weeks)
- NMSQuest（Nonmotor symptoms Questionnaire）(48 weeks)
- Clinical Global Impression(48 weeks)