Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease: a Randomised, Double-blind, Placebo-controlled Trial.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 主要终点
- the change of depression from baseline to 12 weeks
研究概览
简要总结
Depression is one of the most important nonmotor features of idiopathic PD（Parkinson's disease ）which may not just interfere with the motor symptoms of PD but can also cause immense personal suffering as well as decreased quality of life with increased disability and caregiver burden. However,there is little hard evidence to guide clinical treatment. Although some newer dopamine agonists also have antidepressive effect, the use of tricyclic or nontricyclic antidepressants is frequently required.However, the side-effects of these agents may also worsen some preexisting nonmotor problems in PD. Wuling powder is a Chinese medicine which is made by cultivating Xylariasp mycelium using submerged fermentation technology. Xylariasp is the fungus sclerotia which grow in termite nests. Wuling powder is mainly used to soothe nerves and anti-insomnia in clinical. The antidepressant effect of Wuling powder has been confirmed in clinical, but not in the patients of Parkinson's disease. Therefore, the investigators design a randomized, double-blind, placebo-controlled study to evaluate the antidepressant effect of Wuling powder in PD patients and its underlying mechanism.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic Parkinson's disease according to the 2015 MDS（Movement Disorder Society）-PD criterion
- •Hoehn-Yahr stage: 1-3
- •Under steady therapy of antiparkinsonian drugs for at least 28 days
- •MMSE（Mini-Mental State Examination）≥24
- •Neither use antidepressant drugs nor antipsychotic drugs within 4 weeks
- •Signed informed consent
排除标准
- •Have other psychotic symptoms
- •Suicide ideation or behavior
- •Severe cognitive impairment，chronic organs failure，malignant tumors
- •Glutamic-pyruvic transaminase or glutamic oxalacetic transaminase≥1.5 times of the high normal range or white blood cell<4*10^9/L or serum creatinine>84umol/L
- •Pregnancy or lactation period
- •Participant in other trials or have taken other experimental drugs within 90 days
- •Allergic to fungal food or fungal drugs
研究组 & 干预措施
Wuling Powder Group
Take Wuling Powder 3 times a day，3 pills each time for 12 weeks
干预措施: Wuling Powder (Drug)
Placebo Group
Take placebo drug which cannot be distinguished from the experimental drug 3 times a day，3 pills each time for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
the change of depression from baseline to 12 weeks
时间窗: 12 weeks after treatment
the change of depression from baseline to 12 weeks,as assessed with the use of HAMD（Hamilton Depression Scale）
次要结局
未报告次要终点
研究者
Wen Su
Clinical professor and Principal investigator
Beijing Hospital