Comparative, Conceptual, Randomized Clinical Study to Investigate Superiority of Newly Developed Over Basic Echinacea Formulations for the Treatment of Acute Symptoms of Respiratory Tract Infections
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- A. Vogel AG
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- Time to remission from initial episodes
研究概览
简要总结
This is a comparative, conceptual, randomized clinical study to investigate newly developed over basic Echinacea formulations for the treatment of acute symptoms of respiratory tract infections. 400 adults will be recruited, of which approximately 300 will develop a common cold or a influenza-like infection. Two newly developed and two existing Echinacea formulations (solid/liquid) will be randomly dispensed at inclusion for treatment of maximal 3 infections. Treatment starts at first signs of infection and lasts for a maximum of 10 days or until symptom resolution. Nasopharynx samples will be collected for analysis of common viral respiratory agents throughout treatment. Safety and efficacy variables will be assessed.
详细描述
The monocentre trial compares two newly developed pharmaceutical forms of Echinacea (extract from Echinacea purpurea Herba and Radix; lozenges or spray) with two basic and authorised pharmaceutical forms (tablets or drops; comparator groups) for the treatment of acute symptoms of the common cold and/or influenza-like illness (ILI) in adults. Trial subjects are preventatively screened and included in the study (n = 400). If they show acute symptoms of a common cold or ILI during the study period, they are instructed to call the study centre to have confirmed the indication for treatment and begin with the treatment, they are randomized to (1:1:1:1 randomization into one of four groups). The primary endpoint is the time until remission of respiratory symptoms with the new pharmaceutical forms compared to the basic forms during the first episode. Secondary endpoints include remission of all treated episodes (max. 3 episodes), remission times comparison between different pharmaceutical forms (e.g. lozenges vs. spray, lozenges vs. drops etc), reduction of viral load on day 5 and 9 compared to day 1 of treatment (nasopharyngeal swabs), differences in safety (blood parameters before and during treatment), differences in number of adverse events, tolerance and efficacy assessed by the patients.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years old
- •Signed Informed Consent
排除标准
- •Younger than 18 years
- •Participation in another clinical study in the past 30 days
- •Permanent intake of antimicrobial, antiviral, immune suppressive substances
- •Surgical intervention in the 3 months prior to inclusion or planned surgery during period of observation
- •Known diabetes melitus
- •Known and treated atopy or asthma bronchiale
- •Cystic fibrosis, bronchopulmonale dysplasia, COPD
- •Known diseases of the immune system, degenerative illnesses (e.g. auto-immune disorders like AIDS or leukemia, myeloma)
- •Known metabolic or resorptive disorders
- •Known chronic liver diseases (chronic hepatitis, liver cirrhosis)
- •Known chronic kidney insufficiency
- •Serious health issues (reduced health status, autoimmune illness, tumorous illness)
- •Known allergy to plants of compositae family (camomille, dandelion) or to any substances of the investigational product
- •At inclusion known pregnancy or planned pregnancy during period of investigation (required: active contraception for women of childbearing year)
研究组 & 干预措施
Formulation A
Echinacea purpurea alcoholic extract lozenges (novel formulation)
干预措施: Echinacea purpurea alcoholic extract (Drug)
Formulation B
Echinacea purpurea alcoholic extract spray (novel formulation)
干预措施: Echinacea purpurea alcoholic extract (Drug)
Formulation C
Echinacea purpurea alcoholic extract tablet (basic formulation, reference)
干预措施: Echinacea purpurea alcoholic extract (Drug)
Formulation D
Echinacea purpurea alcoholic extract, drops (basic formulation, reference)
干预措施: Echinacea purpurea alcoholic extract (Drug)
结局指标
主要结局
Time to remission from initial episodes
时间窗: maximally 10 days
duration until respiratory symptoms are solved
次要结局
- Time to remission from overall episodes(maximally 10 days)
- Blood safety (red and white cell count)(At Inclusion visit and day 5 of infection)
- Blood safety (creatinin [umol/l])(At Inclusion visit and day 5 of infection)
- Blood safety (ALT [ukat/l])(At Inclusion visit and day 5 of infection)
- Blood safety (AST [ukat/l])(At Inclusion visit and day 5 of infection)
- Cross-comparison of remissions between formulations(maximally 10 days)
- Development of single respiratory symptoms(maximally 10 days)
- Development of respiratory symptom sum score(maximally 10 days)
- Absence from School/Work(during acute respiratory episodes, 7 days each)
- Reduction of viral load in nasopharyngeal samples(day 1, day 5, day 9)
- Subjective assessment of efficacy by patient(At end of treatment cycle of 10 days)
- Blood safety (Bilirubin [umol/l])(At Inclusion visit and day 5 of infection)
- Acceptance of treatment(At end of treatment cycle of 10 days)
- Concomitant medication and -therapy(during acute respiratory episodes of 10 days)
- adverse events(during acute respiratory episodes, from day 1 until follow up at day 17 - 21)
- Subjective assessment of tolerability by patient(At day 10 of every treatment cycle)