Treatment of Patients Suffering From Nervous Restlessness With PASCOFLAIR®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 主要终点
- Change of Symptom Inner Restlessness (Pre - Post)
研究概览
简要总结
The study was carried out as a prospective, non-interventional study with the intention of subsequent process cost analyses (PCA) and also considers quality of life, drug misuse, dependence, adverse events and therapy satisfaction.
详细描述
The study was carried out as a prospective, non-interventional study with the intention of subsequent process cost analyses (PCA) and also considers quality of life, drug misuse, dependence, adverse events and therapy satisfaction. Data were collected in collaboration with 22 physicians in Germany.
The study was designed as a one armed non-interventional study. Patients had to suffer from nervous restlessness in order to be eligible for study documentation. Participants agreed to a medical treatment with PASCOFLAIR® of 12 weeks. In this context, documented patients could take PASCOFLAIR® at the first time or could have started within the past three months before the initial visit. Furthermore, documented patients had to be older than 18 years and must be able to read and understand the patient declaration of data protection and the declaration of consent. The patient must not be an alcoholic, must not be drug dependent and have no other types of addiction. Patients who were pregnant or breast-feeding were not eligible for study participation. Furthermore, patients showing hypersensitivity against passionflower extract or against other components of the medication were excluded. The signed declaration of consent of participating patients is available.
The treatment of affected patients may not be documented, if a redemption (written or spoken) of the declaration of consent is existing or the patient takes Benzodiazepines.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients suffering from nervous restlessness
排除标准
- •Age < 18 years and must be able to read and understand the patient declaration of data protection and the declaration of consent
- •alcoholics, drug pending, addictive disorder
- •pregnancy or lactating
- •patients showing hypersensitivity against passionflower extract or against other components of the medication
结局指标
主要结局
Change of Symptom Inner Restlessness (Pre - Post)
时间窗: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"
次要结局
- Tolerability Assess Using a 5 Point Scale(Evaluation of Tolerability on visit 3 (appr. 12 weeks after baseline))
- Change in EQ-5D (Health Questionnaire) Scores (Pre - Post)(Change from Baseline (before treatment) to last visit (end of observation- approx. 12 weeks after baseline))
- Change of Symptom Fear (Pre - Post)(Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline))
- Change of Symptom Transpiration (Pre - Post)(Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline ))
- Change of Symptom Sleep Disturbance (Pre - Post)(Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline))
- Change of Symptom Exhaustion (Pre - Post)(Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline))
- Change of Symptom Trembling (Pre - Post)(Change from Baseline (before treatment; week 0) to last visit (end of observation - approx. 12 weeks after baseline))
- Change of BDEPQ (Benzodiazepine Dependence Questionnaire)(Change from visit 2 (approx. 4 weeks after baseline) to last visit (end of observation- approx. 12 weeks after baseline))
- Change of Symptom Lack of Concentration (Pre - Post)(Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline))
- Change of Symptom Nausea (Pre - Post)(Change from Baseline (before treatment; week 0) to last visit (end of observation-approx. 12 weeks after baseline))
- Change of Symptom Palpation (Pre - Post)(Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline))
- Change of RS-13 (Resilience Questionnaire) (Pre - Post)(Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline))
- Change of EQ-5D VAS Scores (Pre - Post)(Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline))