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ISRCTN
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ISRCTN90651143
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ClinicalTrials.gov identifier
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Public title
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Homeopathy for Irritable Bowel Syndrome (HIBS)
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Scientific title
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A randomised controlled trial to evaluate the clinical and cost effectiveness of two adjunctive treatments for patients with irritable bowel syndrome (IBS) compared to usual care alone: A - Homeopathic treatment (consultation + homeopathic medicine) and B - Supportive listening
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Acronym
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HIBS
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Serial number at source
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HIBS_ protocol_final_v3_ 19_07_11
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Study hypothesis
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This study is designed to test three different hypotheses.
1. Homeopathic consultation + a “medication that may help” (homeopathic medicine) + usual care will improve the outcomes of patients with IBS in comparison to usual care alone
2. Homeopathic consultation + a ‘medication that may help’ (homeopathic medicine) + usual care will result in significantly more benefit than supportive listening + usual care
3. Supportive listening + usual care will improve the outcomes of patients with IBS in comparison to usual care alone
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Lay summary
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Lay summary under review
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Ethics approval
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Leeds (East) Research Ethics Committee approved on 9 December 2010, ref: 10/H1306/73
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Study design
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Cohort multiple randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Irritable bowel syndrome
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Participants - inclusion criteria
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1. Diagnosis of Irritable bowel syndrome (according to ROME III diagnostic criteria for IBS)
2. Aged 18 and over
3. Consent to fill in and return further postal questionnaires to the researchers
4. Score of more than 100 on the IBS Symptom Severity Score (Francis et al., 1997), this score if often taken as the cut off for symptomatic IBS
5. Fluent in English
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Participants - exclusion criteria
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1. Pregnant or breast feeding
2. Unstable medical or psychiatric illness
3. Currently receiving treatment from a homeopath or taking homeopathic medicines
4. Current diagnosis of haemophilia or cancer, or major gastrointestinal surgery in previous 6 months
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Anticipated start date
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14/01/2011
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Anticipated end date
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31/12/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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198
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Interventions
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Three armed trial using the ‘cohort multiple RCT’ design (Relton 2010). The three arms will be:
1. Homeopathic treatment + usual care
2. Supportive listening + usual care
3. Usual care alone
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Primary outcome measure(s)
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Irritable bowel syndrome symptom severity scale
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Secondary outcome measure(s)
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1. Hospital Anxiety and Depression Scale (HADS)
2. EQ-5D
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Sources of funding
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1. Barnsley Hospital - Small Grants Fund (UK)
2. Friends of Barnsley Hospital (UK)
3. Homeopathy Research Institute (UK)
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Trial website
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Publications
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Contact name
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Dr
Kapil
Kapur
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Address
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Barnsley Hospital NHS Foundation Trust
Gawber Road
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City/town
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Barnsley
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Zip/Postcode
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S75 2EP
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Country
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United Kingdom
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Sponsor
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Barnsley Hospital NHS Foundation Trust (UK)
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Address
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c/o Mr Michael Bramall
Gawber Road
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City/town
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Barnsley
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Zip/Postcode
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S75 2EP
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Country
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United Kingdom
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Sponsor website:
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http://www.barnsleyhospital.nhs.uk/
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Date applied
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03/10/2011
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Last edited
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14/11/2011
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Date ISRCTN assigned
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14/11/2011
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