Clinical Evaluation of the AP203 Plant Extract Mixture in Adult Patients With Increased Incidence of Viral and/or Bacterial Upper Respiratory Tract Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Efficacy and safety of AP203
研究概览
简要总结
The aim of the study was to assess the efficacy and safety of AP203 preparation (RESCOVIN®) in a group of patients with increased incidence to viral and/or bacterial upper respiratory tract infections.
详细描述
Randomized, double-blind, cross over study conducted under medical supervision on 1) group of 30 patients receiving AP203 mixture in capsule form and 2) group of 30 receiving placebo. After a washout period a group receiving placebo receiver AP203 mixture in syrup form.
The study group was adult patients with an increased incidence of upper respiratory tract infection. During the study, the effect of a mixture of AP203 extracts (RESCOVIN®) on markers of inflammation and oxidative stress and the effect on the incidence of upper respiratory tract infections was assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women and men, 18-70 years old
- •Healthy patients at the time of enrollment to the study (without active upper respiratory tract infection)
- •Presence of 2 or more episodes of upper respiratory tract infections or >=2 episodes of cold during the year
- •Patients with chronic upper respiratory tract diseases including bronchial asthma
- •Signed informed consent
- •Women: contraception or postmenopausal age
排除标准
- •Intake of supplements containing plant extracts, polyphenols or anthocyanins for the 3 months prior to the study initiation
- •Acute inflammation
- •Oral immunosuppressive drugs
- •Steroid, anti-allergic drugs in exacerbations of chronic disease at least 2 months from the start of study participation
- •Antibiotic therapy 1 month prior to study initiation
- •Participation in another clinical trial;
- •Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukaemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplantation;
- •Hypersensitivity/allergy to any of the ingredients of the product, allergy to plants of the Asteraceae family (e.g. chamomile, calendula);
- •Women who are pregnant or planning to become pregnant during the study period;
结局指标
主要结局
Efficacy and safety of AP203
时间窗: Baseline, 2 months, 4 months, 6 months
Clinical evaluation of the efficacy and safety of AP203, in a group of patients with an increased incidence of viral and/or bacterial upper respiratory tract infections.
次要结局
- 8-iso-PGF2IsoP level(Baseline, 2 months, 4 months, 6 months)
- hsCRP level(Baseline, 2 months, 4 months, 6 months)
- Cold Intensity Score(Baseline, 2 months, 4 months, 6 months)