Efficacy and Safety of SQJZ Herbal Mixtures on Non-motor Symptoms in Parkinson's Disease Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- changes of The Nonmotor Symptoms Scale (NMSS) from baseline after 12-weeks treatment.
研究概览
简要总结
The purpose of this study is to examine the efficacy and safety of SQJZ Herbal Mixtures on non-motor symptoms of PD patients.
详细描述
This will be a multicentre, double-blind, placebo-controlled, parallel-group trial. Patients will be randomly assigned via an random number table to either the SQJZ herbal mixtures or placebo in a 2:1 ratio. Randomization will be stratify by age and gender. All participants are asked to maintain the regular medication schedule during the 12-week intervention. Assessments are conducted prior to the intervention and at 4-week, 8-week and 12-week directly after the intervention. Also, long-term effects will be assessed at 24 weeks of follow-up (from post-enrolment). The assessments will be performed by a blinded investigator who is not involved in the randomization.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has idiopathic Parkinson's disease with diagnostic standard of (UKPDC)
- •Subject has a Hoehn and Yahr stage score ≤4
- •Subject is male or female, ≥18 years of age，and≤80 years.
- •Subject has a total Non-Motor Symptoms Scale (NMSS) score ≥40
- •If the subject is receiving levodopa (L-DOPA),anticholinergics, monoamine oxidase (MAO) B inhibitors, or amantadine, he/she must have been on a stable dose for at least 28 days prior to the Baseline Visit and must be maintained on that dose for the duration of the study
- •Subject agree to sign an informed consent.
排除标准
- •Subject is receiving therapy with anti-Parkinson's disease drugs(include levodopa (L-DOPA), amantadine, anticholinergics, monoamine oxidase (MAO) B inhibitors, dopamine receptor agonists or catechol-O-methyltransferase inhibitor),which is not under the guidance of professional doctors,either concurrently or within 28 days prior to the Baseline Visit.
- •Subject is receiving therapy with 1 of the following drugs, either concurrently or within 28 days prior to the Baseline Visit: alpha-methyl dopa, metoclopramide, reserpine, sibelium ,neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, and quetiapine), monoamine oxidase-A (MAO-A) inhibitors, methylphenidate, amphetamine.
- •Subject is receiving central nervous system (CNS) therapy (eg, sedatives, hypnotics, selective serotonin reuptake inhibitors [SSRIs], anxiolytics, or other sleep-modifying medication) unless dose has been stable daily for at least 28 days prior to the Baseline Visit and is likely to remain stable for the duration of the study
- •Subject has visual hallucination,and the visual hallucination happened within 1 year after been diagnosed with PD.
- •Subject has delirium。
- •Subject has Other digestive, Urological , blood system , endocrine , immune system or cardiopulmonary problems that in the view of the researchers.
- •Subject has Serum creatinine≥97umol/L；or the alanine aminotransferase(ALT) ≥40U/L;or aspartate aminotransferase≥40U/L。
- •Subject has a epilepsy history.
- •Subject has evidence of an impulse control disorder, a history of mental illness, thoughts or behaviors of suicide.
- •According to the assessment of the investigator,Subject cann't complete the study due to poor compliance, drug or Alcohol abuse.
- •Subject is participating in other clinical trials or Participated in the past 2 weeks.
研究组 & 干预措施
Placebo
placebo identified to SQJZ herbal mixtures, 29.375g, 2 times per day.for 12 weeks.
干预措施: Placebo (Drug)
SQJZ herbal mixtures
SQJZ herbal mixtures 29.375g, 2 times per day.for 12 weeks.
干预措施: SQJZ herbal mixtures (Drug)
结局指标
主要结局
changes of The Nonmotor Symptoms Scale (NMSS) from baseline after 12-weeks treatment.
时间窗: baseline, 4-week, 8-week, 12-week and 24-week.
The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in the following 9 domain categories: cardiovascular, including falls; sleep/fatigue; mood/cognition; perceptual problems/hallucinations; attention/memory; gastrointestinal tract; urinary; sexual function; miscellaneous. Severity and frequency are rated using a 4-point scale ranging from 0 (none) to 3 (severe; major source of distress or disturbance to subject) for severity and from 1 (rarely) to 4 (very frequent \[daily or all the time\]) for frequency. The total NMSS score ranges from 0 to 350. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS. The NMSS was assessed at introduction period, baseline, 4-week, 8-week, 12-week and 24-week.
次要结局
- changes of The Unified Parkinson's Disease Rating Scale (UPDRS) from baseline after 12-weeks treatment.(baseline, 4-week, 8-week, 12-week and 24-week.)
- changes of The Parkinson's Disease Questionnaire-39 (PDQ-39) from baseline after 12-weeks treatment.(baseline, 12-week and 24-week)
研究者
Jinzhou Tian
vice-president
Dongzhimen Hospital, Beijing