Management of Acute Bronchitis in Switzerland With Pelargonium Sidoides Extract EPs®7630 Versus Usual Care - a Pragmatic, Open-label, Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 412
- 试验地点
- 1
- 主要终点
- Effectiveness of Pelargonium sidoides extract EPs® 7630
研究概览
简要总结
The aim of our study is to conduct a pragmatic RCT meeting all required standards to evaluate the effectiveness of Pelargonium sidoides extract, EPs® 7630, in the management of acute bronchitis with or without COVID-19 in PCP practices and walk-in clinics in French-speaking Switzerland. The RCT will be preceded by a pilot phase to ensure its feasibility.
详细描述
The goal of this clinical trial is to evaluate the effectiveness of Pelargonium sidoides extract EPs® 7630, also known under the brand name Kaloba®, in the management of acute bronchitis.
The main questions it aims to answer are:
- Is Pelargonium sidoides extract EPs® 7630 effective to reduce the severity and the duration of symptoms related to acute bronchitis ?
- Does Pelargonium sidoides extract EPs® 7630 allow to reduce the prescription of antibiotics?
Participants will be randomize 1:1 either in the control group (usual care) or in the intervention group (Pelargonium sidoides extract EPs® 7630).
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
- None
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
- •Adult patients (aged 18 and over) consulting for the first time, for the same episode, either for an acute cough (≤8 days) as the main symptom, suggestive of acute bronchitis, or for an illness (≤8 days) in which cough is not the main symptom but PCP believes that acute bronchitis is the most likely diagnosis.
- •Patients tested positive to COVID-19 who meet the above-mentioned criteria will be included too.
排除标准
- •Infection requiring antibiotic treatment (ex. cystic fibrosis)
- •Pneumonia
- •Known hypersensitivity to Pelargonium sidoides extract or excipients of the trial medication
- •Non-infectious causes (COPD, asthma, pulmonary embolism, heart failure, gastroesophageal reflux, allergy)
- •Lacking the faculty of discernment (for example: dementia, decompensated psychosis or severe depression)
- •Inability to fill out the diary (no ability to read and understand French)
- •Pregnancy or breastfeeding
- •Immunological deficiencies
- •Hospitalization
- •Severe hepatic disease
- •Patients who have already started a treatment with Pelargonium sidoides EPs® 7630 for this current episode (Kaloba®, Umckaloabo®)
- •Important risk of bleeding (severe thrombocytopenia and anticoagulant intake)
- •If the patient is taking a drug among these classes of drugs:
- •anticoagulants, immunosuppressants, chemotherapy or immunotherapy
研究组 & 干预措施
Control group
Usual care. Reference therapies, which are classified as symptomatic treatments, are chosen freely by the PCP except for phytotherapy
干预措施: usual care (Other)
Intervention group
The solution of Pelargonium sidoides extract EPs® 7630:
3x30 drops/day for 7 days and will be advised to pursue the treatment until the end of symptoms if bothered by the cough up to a maximum of 21 days.
干预措施: Pelargonium sidoides extract EPs® 7630 (Other)
结局指标
主要结局
Effectiveness of Pelargonium sidoides extract EPs® 7630
时间窗: 22 days
Effectiveness will be determined by comparing the number of days needed to achieve a 50% reduction in the ABSS score after peak of symptoms in each group.
Proportion of patients taking antibiotics
时间窗: 22 days
The co-medication, including antibiotics, will be collected by the investigator at day 4, 8 and 22. The results will be compared between the two arms.
次要结局
- Integration of a herbal medicinal product in conventional settings(22 days)