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    Summary
    EudraCT Number:2005-005934-11
    Sponsor's Protocol Code Number:RNLICCCWF1
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-05-19
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2005-005934-11
    A.3Full title of the trial
    Investigating the possible Therapeutic Effects of the Homoeopathic Remedy Apis Mellifica on Weaver Fish Stings using a Double Blind Randomised Control Trial.
    A.3.2Name or abbreviated title of the trial where available
    Treatment Time Reduction of Weaver Sting using Homoeopathic Apis (RCT)
    A.4.1Sponsor's protocol code numberRNLICCCWF1
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN16880978
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCornwall College Camborne
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    B.Sponsor: 2
    B.1.1Name of SponsorRoyal National Lifeboat Institution
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHomoeopathic Apis mellificia
    D.3.2Product code Apis
    D.3.4Pharmaceutical form Pillules
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product Yes
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPillules
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical 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.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.

    E.2.2Secondary 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.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal 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.
    E.4Principal 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.
    E.5 End points
    E.5.1Primary 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.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other 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.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial 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
    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.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-05-19. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 250
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    If participants are still suffering from the sting after the initial hour, they will be cared for by the beach lifeguards in the standardised way already in practice. The participant will also be given an information pack with details of Homoeopathic practicioners and GPs phone numbers if needed after the trial has ended, and an information pack containing all details of the weaver fish and homoeopathic trial for their GP if needed.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-07-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-09-01
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