E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Our medical condition is classified as T63.5 according to the World Health organisation (WHO) International classification of disease. this will be an immunological response to the venom contained within the sting from a lesser weaver fish, which might include localised pain, swelling, discolouration, inflammation, coldness or heat in the affected part. |
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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 |
To ascertain whether or not the homoeopathic preparation of the remedy apis-mellifica has a beneficial therapeutic effect on the sting from a weaver fish. In order to prove the remedy effective under scientific scrutiny. To make more efficient use of the RNLI’s budget and the reduce the time spent with each weaver fish sting victim, thus freeing the lifeguards to perform other tasks.
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E.2.2 | Secondary objectives of the trial |
To provide a pilot research project that will allow us to investigate and develop grounded theories and methods from which to create a main and geographically larger trial the following year. To further CAM research under scientific scrutiny,thus enhancing its credibility. To provide via the publication in PubMed and the Complementary and Alternative Medicine Journal, a protocol blue print for anyone wishing to carry out future research of a similar nature. To train RNLI staff in the safe administration of a Homoepathic remedy. To promote Camborne College Cornwall as a research establishment thus enhancing the availability of funding for further research opportunities.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Healthy volunteers as stated by the criteria of a type 1 clinical trial, understanding enough spoken and written english to give informed written consent, over 16 years of age, under 65 years of age, and covered by the NHs and not excluded by any of the following exclusion criteria. |
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E.4 | Principal exclusion criteria |
Members of the public who arrive at the Perranporth lifeguard hut for assistance with a weaver fish sting will be approached and asked if they would be willing to take part in a trial. Participants will be screened in the initial stages for suitability; there will be strict exclusion factors for treating the public. Researchers will complete the contra-indication form with the potential participant asking them if they have any of the exclusion criteria as follows:
. Identification and Selection of Participants Participants will be screened in the initial stages for suitability; there will be strict exclusion factors for treating the public. Researchers will complete the contra-indication form with the potential participant asking them if they have any of the exclusion criteria as follows: (Contra- indications and medical history) o Heart conditions o Diagnosed with any form of psychological disorder o Taking ANY prescribed medication, anti-retroviral, steroids, hay-fever medication. o Are they over 65 years of age o Under 16 years of age. (See Appendix N: Consent in Children) o If they have any Strong anaphylactic tendencies to bees / stings. o Have they already taken any form of treatment for the sting o Have they already been stung this year o If the participant does not speak / read English, because of the need for `informed consent` o If they were stung over an hour before reaching the lifeguard hut o Participants who may have been coerced in any way to take part in the trial. o People who have not given written informed consent o If their behaviour is inappropriate or may cause a potential risk to the researchers and other participants in the trial or in any way jeopardise the trial. o Individuals who are not covered by the National Health Service. o Pregnancy / nursing mothers (See Appendix H: Contraindications)
The researcher will then confirm if the person is able to give informed written consent E.g. they are able to speak and read English and over the age of sixteen according to the Gillick and Fraser procedure for determining Child Competence in administering immunisation and vaccines to adolescents. . After the recognition that all of the required criteria have been met, suitable individuals will take part in the trial. Persons unable or unwilling to take part will be given the standard treatment for the sting.
The researcher will then confirm if the person is able to give informed consent. After the recognition that all of the required criteria have been met and the participant disclaimer has been signed by the member of the public, suitable individuals will then take part in the trial. Persons unable or unwilling to take part will be given the standard treatment for the sting.
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E.5 End points |
E.5.1 | Primary end point(s) |
The end point will be when the participant feels recovered enough to leave of their own volition or have been observed and treated for a time of one hour from giving written informed consent to take part in the trial. Participants who are still suffering longer than this time will continue with the standard treatment available.
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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 | No |
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 | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
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.8.5 | 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 | Information not present in EudraCT |
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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The end of the practical side for the trial will be when the weaver fish season on the beach has finished, end of August, into early september 2006. After that data collection and collation will take place until statistical evidence can be formulated and made into a format ready for publication.
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |