Open, Controlled Prospective, Explorative Clinical Trial to Assess Pharmacology and Effectiveness of Echinaforce Chewable Tablets "EC" to Prevent From Enveloped Virus Infections
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- A. Vogel AG
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Incidence of respiratory tract infections "vRTIs" with treatment in comparison to no treatment
研究概览
简要总结
It is a single-center, randomized, open-label, phase IV study for the explorative investigation of the pharmacological mode-of-action of Echinaforce® extract in the form of Echinaforce® Chewable tablets"- Further, it is aimed to evaluate the effectiveness of the study product for the prevention and treatment of respiratory tract infections in generally healthy adults following a real-life setting. The study covers 2x2 + 1 month of prevention in 120 randomized participants following a tight sampling set-up for sensitive detection of viral infections by RT-qPCR analysis of nasal swabs and seroconversion of SARS-CoV2 IgG/IgM in serum samples.
详细描述
It is a single-center, randomized, open-label, phase IV study for the explorative investigation of the pharmacological mode-of-action of Echinaforce® extract in the form of Echinaforce® Chewable tablets"- Further, it is aimed to evaluate the effectiveness of the study product for the prevention and treatment of respiratory tract infections in generally healthy adults following a real-life setting. The study covers 2x2 + 1 month of prevention in 120 randomized participants following a tight sampling set-up for sensitive detection of viral infections by RT-qPCR analysis of nasal swabs and seroconversion of SARS-CoV2 IgG/IgM in serum samples.
Study flyers are presented in waiting rooms at GPs/hospitals locally and study information is forwarded via the study centre network to attract interest of potential participants. Altogether, 140 participants shall be recruited (screened) by the study. Interested persons shall be invited to the study centre for first informative visit 1 (V1). Participants encountering acute symptoms during screening and/or run-in phase can be included as well. The number of recurrences that can be treated and documented per participant during the time of observation in this study is in principal unlimited. Participants are equipped with study product and study diaries sufficient to encounter a max of 3 individual respiratory tract infections "RTI".
The commercially available study product "Echinaforce Chewable "EC" tablets shall be compared to no treatment in study participants that were randomized equally to the two study groups: 1) "Treatment group" and 2) "no-treatment group". Participants assigned to the "treatment group" are instructed to perform 2 consecutive prevention periods taking 3x2 EC tablets daily for 2x2 months followed by a voluntary, 1 month follow up prevention in frame of this study. After each 2 month prevention phase, participant interrupted prevention for 1 week before starting with a new phase. Intake of regular preventive supplements is recorded as per eCRF entries (V1-V7) and intake of co-medication to treat acute RTI symptoms as per study diary entries. Participants should contact the study coordinator as soon as possible upon first signs of acute cold-/flu like symptoms. The study coordinator confirms the symptoms and instructs participants to start taking 5x2 instead of 3x2 EC tablets daily immediately.
Quality assurance:
Informed Consent Forms, individual e-CRFs accounts and paper study diaries, investigator records, medical test results, and study product must be accessible at all times to study monitors commissioned by the CRO (CONVEX CRO Ltd.) on behalf of and mandated by the sponsor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 - 75 years.
- •Written informed consent.
- •Good knowledge of respective language.
- •Willingness to give swab samples.
- •Willingness to give blood and saliva samples.
排除标准
- •≥76 years
- •< 18 years.
- •Participation in another clinical study in the past 30 days or planned during study conduct.
- •Permanent intake of antimicrobial, antiviral, immune suppressive substances.
- •Surgical intervention in the 3 months prior enrolment or planned intervention during the study conduct.
- •Known diabetes mellitus.
- •Known atopy (a constitution to produce an exaggerated immune response to otherwise harmless environmental substances, with clinical manifestation of an allergic disease such as allergic rhinitis, eczema, asthma, atopic dermatitis, etc.)
- •Cystic Fibrosis, bronchopulmonary dysfunction, COPD.
- •Known immune system disorders and degenerative disorders (autoimmune disorders, AIDS, leukaemia, lymphoma, myeloma).
- •Known metabolic or resorption disorders.
- •Known liver or kidney illnesses (chronic hepatitis, liver cirrhosis, chronic kidney insufficiency).
- •Serious health conditions (limited general condition, auto-immune diseases, tumorous diseases, neurological disorders)
- •Known allergies to plants of the compositae family (e.g. camomile or dandelion) or one of the compounds in the investigational product
- •Known or planned pregnancy during study period (effective contraception is required).
研究组 & 干预措施
Treatment group
Treatment group, 3 x 2 Echinaforce chewable tablets (EC, 3x800mg) daily during prevention and 5 x 2 EC (5x800mg) during acute viral Respiratory tract infection "vRTIs"
干预措施: Echinaforce Chewable tablets (Drug)
结局指标
主要结局
Incidence of respiratory tract infections "vRTIs" with treatment in comparison to no treatment
时间窗: 5 months
The incidence of respiratory tract infections "vRTIs" with treatment in comparison to no treatment is determined as per study diary entries (acute symptomatic episodes of RTIs), by taking nasal swab samples and blood samples from participants during prevention and acute vRTIs. Swab samples are taken by using validated swab sticks (COPAN) and presence of viral RNA/DNA determined by using the RT-PCR respiratory pathogen panel from VIASURE ®, plus a separate panel for SARS-CoV2. Seroconversion of SARS-CoV2 specific IgG/IgM levels is used to detect additional asymptomatic vRTIs. Analyses are done by a non-parametric Chi-square test
次要结局
- Incidence rate of respiratory tract infections complications, recurrences and antibiotic use(5 months)
- Explorative assessment of the absolute and relative changes in the concentration of cytokine/chemokine-levels(5 months)
- Changes of viral load and incidence of responder(5 months)
- Development of symptom scores of respiratory tract infections(5 months)
- Duration of respiratory tract infections(5 months)
- Incidence of household members of participants with acute cold/flu symptoms and confirmed SARS-CoV2/Influenza infections.(5 months)
- Rate of lost work and lost school days.(5 months)
- Explorative assessment of the absolute and relative changes in the concentration of immunoglobulin-levels (IgM/IgG)(5 months)
- Absolute and relative change of sleep quality(5 months)
- Subjective treatment effectiveness in view of participants(5 months)
- Assessment of subjective rating of tolerability(5 months)
- Assesment of subjective ratings of acceptance(5 months)
- Cumulative number of sick days(5 months)
- Change of subjective impression of resistance status during the time of observation(5 months)
- Absolute and relative change of perceived stress.(5 months)
- Subjective treatment effectiveness in view of investigator(5 months)
- Explorative assessment of the absolute and relative changes of the Degree of epigenetic modifications(5 months)
- Preventive supplements, concomitant medication and -therapies.(5 months)
- Incidence and severity of symptoms other than those recorded in the study diary (S/AE)(5 months)