EUCTR2005-005934-11-GB进行中（未招募）1 期
Investigating the possible Therapeutic Effects of the Homoeopathic Remedy Apis Mellifica on Weaver Fish Stings using a Double Blind Randomised Control Trial. - Treatment Time Reduction of Weaver Sting using Homoeopathic Apis (RCT)
Cornwall College Camborne0 个研究点目标入组 250 人开始时间: 2006年5月19日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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)
- •oHeart conditions
- •oDiagnosed with any form of psychological disorder
- •oTaking ANY prescribed medication, anti-retroviral, steroids, hay-fever medication.
- •oAre they over 65 years of age
- •oUnder 16 years of age. (See Appendix N: Consent in Children)
- •oIf they have any Strong anaphylactic tendencies to bees / stings.
- •oHave they already taken any form of treatment for the sting
- •oHave they already been stung this year
- •oIf the participant does not speak / read English, because of the need for `informed consent`
- •oIf they were stung over an hour before reaching the lifeguard hut
- •oParticipants who may have been coerced in any way to take part in the trial.
- •oPeople who have not given written informed consent
- •oIf 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.
- •oIndividuals who are not covered by the National Health Service.
- •oPregnancy / 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.
研究者
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