NCT02174653已完成3 期
Safety and Intake Effect of EPs® 7630 (an Extract of the Roots of Pelargonium Sidoides) A Prospective, Monocentric, Randomised, Double-blind, Placebo-controlled Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 720
- 试验地点
- 1
- 主要终点
- Occurrence of Adverse Drug Reactions (ADRs)
研究概览
简要总结
The aim of the study is to evaluate the safety of the intake of EPs® 7630 during a long-term (4 months) medication. The protective effects of EPs®7630 and its effects during a cold episode will also be studied.
详细描述
The main objective of this clinical trial is to evaluate the safety of EPs® 7630 intake - used as continuous protection and at the onset of cold symptoms - in adult participants during a long-term (4 months) medication. Due to the sparseness of empirical data in the population and this setting, no confirmatory hypotheses are formulated and the data will be analysed descriptively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
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
- •Adult male or female participant (at least 18 years old)
- •Participant provided a written informed consent in accordance with the legal requirements
- •Participant with willingness and ability to comply with all procedures of the clinical trial and be available for the duration of the study
- •Participant is of good physical and mental condition
- •Participant experienced at least 2 colds per year in the last 12 months
排除标准
- •Chronic respiratory tract or lung disease (e.g. chronic bronchitis, COPD, bronchial asthma, cystic fibrosis, active pulmonary tuberculosis, lung cancer)
- •History of heart, renal, liver, neuromuscular disease and/or immunosuppression
- •Known allergic bronchial asthma
- •Known or suspected congenital anomalies of heart, kidney, liver, or mental disabilities
- •Participant with concomitant medications that might impair the interpretation of trial results (e.g. herbal medications for common cold other than the investigational product, or pain relief medications other than Paracetamol or Ibuprofen)
- •Women of child-bearing potential with no adequate and effective contraception (MHRA, 2010):
- •Established use of oral, injected or implanted hormonal methods of contraception
- •Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- •Barrier methods of contraception: Condom and/or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
- •Sexual abstinence
- •Vasectomised partner
- •Female participant who is pregnant, lactating or planning pregnancy during the course of the clinical trial
- •Participant with cold symptoms at inclusion
- •Current intake of antimicrobial and/or antiviral medication for any reason
- •Participant with known or suspected history of alcohol or drug abuse
- •Heavy smoking (more than 10 cigarettes per day)
- •Psychiatric disorders which may influence the results of the trial, epilepsy, or suicide attempts
- •Planned surgical intervention during the trial
- •Known gastrointestinal disorders with uncertain absorption of orally administered medication (e.g. partial or total gastrectomy, enterectomy, inflammatory bowel disease, celiac disease, symptomatic lactose intolerance, dysbacteriosis) or associated with diarrhoea
- •Known or suspected hypersensitivity to the active substance or to any of the excipients of the investigational product
- •Known clinically relevant laboratory abnormalities
- •Participant with increased tendency to bleed, especially nasal or gingival bleeding
- •Previous (within the last 3 months prior to visit 1) or concomitant treatment with coagulation-inhibiting drugs such as warfarin
- •Participation in a further clinical trial at the same time or within the last 4 weeks prior to inclusion into the present study
- •Previous randomisation in the present clinical study
- •Irresponsible subjects or those unable to understand nature, meaning and consequences of the trial
研究组 & 干预措施
EPs® 7630
Active Comparator
Active Comparator 20 mg EPs® 7630 film-coated tablet
- During the common cold free period: One film-coated tablet (20 mg) three times a day
- During a common cold episode: Two film-coated tablets (1 x 20 mg and 1x placebo) three times a day (in the morning, midday and evening; total daily dose 60 mg) over the individual treatment duration of 14 consecutive days.
干预措施: EPs® 7630 (Drug)
EPs® 7630
Active Comparator
Active Comparator 20 mg EPs® 7630 film-coated tablet
- During the common cold free period: One film-coated tablet (20 mg) three times a day
- During a common cold episode: Two film-coated tablets (1 x 20 mg and 1x placebo) three times a day (in the morning, midday and evening; total daily dose 60 mg) over the individual treatment duration of 14 consecutive days.
干预措施: Placebo (Drug)
EPs(R) 7630
Active Comparator
Active Comparator 20 mg EPs® 7630 film-coated tablet
- During the common cold free period: One film-coated tablet (20 mg) three times a day
- During a common cold episode: Two film-coated tablets (2 x 20 mg = 40 mg) three times a day (in the morning, midday and evening; total daily dose 120 mg) over the individual treatment duration of 14 consecutive days.
干预措施: EPs® 7630 (Drug)
Placebo
Placebo Comparator
- During the common cold free period: One film-coated tablet (placebo) three times a day
- During a common cold episode: Two film-coated tablet (placebo) three times a day (in the morning, midday and evening) over the individual treatment duration of 14 consecutive days.
干预措施: Placebo (Drug)
结局指标
主要结局
Occurrence of Adverse Drug Reactions (ADRs)
时间窗: during the 4 months treatment
次要结局
- Occurrence of Adverse Events (AEs) during the 4 months treatment(Adverse events will be documented during the 4 months treatment period.)
- Effects during a cold episode(Treatment effects on common cold symptoms will be documented for 14 days after onset of first common cold symptom)
- Protective effects(Protective effects will be evaluated during the 4 months treatment period.)
研究者
研究点 (1)
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