E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The herbal medicine extract of Echinacea has been widely used to help prevent colds for over 50 years in Europe and the USA. Although the medicine has been used safely for long term treatment over several months during the common cold season without any safety issues, the EU regulatory authorities now require confirmatory safety data for this prophylactic use of the medicine before granting a license for long term use of the medicine.
This study will investigate the safety profile of a 4-month's prophylactic treatment with Echinaforce (an herbal extract from Echinacea purpurea)by measuring adverse events and adverse drug reactions (with one at least possible causal relation to the study drug). The occurrence of events are compared after "non-inferiority" to the treatment with placebo (inactive treatment, sham-treatment). In addition, blood samples are drawn before and after treatment and analyzed for any changes regarding haematological and biochemical measures. Leukocytes and Lym |
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E.2.2 | Secondary objectives of the trial |
Secondary aims are to investigate the efficacy of Echinaforce to prevent common cold episodes in comparison to placebo and to look at its efficacy to reduce severity and duration of the occurring cold episodes, again in comparison to placebo. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
On average ≥ 2 cold episodes per year Age ≥ 18 years Good physical condition Signed informed consent |
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E.4 | Principal exclusion criteria |
Women without appropriate and effective contraception Participation in a clinical trial 30 days prior to this trial Pregnant or breast feeding women Subjects with pre-existing cold symptoms for more than 24h at inclusion Concurrent participation in another clinical trial Intake of antimicrobial and/or antiviral medications at inclusion Alcohol and/or drug abuse, narcotic drug addiction before and during trial (more than 50 gr and / or 10 cigarettes per day) Psychiatric disorders which may influence the results of the trial, epilepsy, suicide attempts Planned surgical intervention during the trial. Serious chronic diseases which influence the absorption, metabolism and the elimination of the investigational product, especially progressive systemic illnesses like tuberculosis, leukaemia, collagen disorders and multiple sclerosis Known AIDS, HIV-infections and autoimmune diseases Known diabetes mellitus (type 1) Corticosteroid-treated asthma Atopic and allergic subjects (under medicinal treatment) Known allergy to plants of the composite family (Asteraceae) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Confirmation of non-inferiority of Echinaforce® compared to placebo in the incidence of Adverse Drug Reactions.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Exclusion visit of the last participant |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |