Condition category
Respiratory
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
28/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr E A Thompson

ORCID ID

Contact details

Bristol Homeopathic Hospital
Cotham Hill
Bristol
BS6 6JU
United Kingdom
+44 0117 973 1231
elizabeth.thompson@ubht.swest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0632177581

Study information

Scientific title

Acronym

Study hypothesis

Can homeopathy in addition to standard care, increase symptom free days and improve asthma control and quality of life in children with poorly controlled asthma?

Ethics approval

Added September 2008: favourable ethical opinion from the Oxfordshire Research Ethics Committee B (UK) on 22/11/2005.

Study design

Pilot RCT

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Respiratory: Asthma

Intervention

1. Homeopathy plus standard care
2. Standard care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

As this is a pilot study there is no primary outcome measure. The research team are actively investigating whether subjective measures such as asthma control or asthma QOL or MYMOP or objective measures such as FEV1, antibiotic use will be most useful.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/2005

Overall trial end date

30/11/2006

Reason abandoned

Eligibility

Participant inclusion criteria

The study aims to recruit 50-80 participants divided equally between intervention and control groups. Inclusion criteria: Children aged 7-14 years who are attending respiratory outpatients and who are at step 2 or step 3 or above on the British Thoracic Guidelines.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

80

Participant exclusion criteria

Children who are presently using homeopathy or who are too unwell to take part or refuse informed consent.

Recruitment start date

01/12/2005

Recruitment end date

30/11/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bristol Homeopathic Hospital
Bristol
BS6 6JU
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Avon Primary Care Research Collaborative (UK) NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21784328

Publication citations

  1. Results

    Thompson EA, Shaw A, Nichol J, Hollinghurst S, Henderson AJ, Thompson T, Sharp D, The feasibility of a pragmatic randomised controlled trial to compare usual care with usual care plus individualised homeopathy, in children requiring secondary care for asthma., Homeopathy, 2011, 100, 3, 122-130, doi: 10.1016/j.homp.2011.05.001.

Additional files

Editorial Notes