A pilot study to investigate whether the homeopathic approach, in addition to standard care, can increase symptom free days and improve asthma control and quality of life in children with poorly controlled asthma

ISRCTN	ISRCTN61654746
DOI	https://doi.org/10.1186/ISRCTN61654746
Protocol serial number	N0632177581
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder	Avon Primary Care Research Collaborative (UK) NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr E A Thompson
Scientific

Bristol Homeopathic Hospital
Cotham Hill
Bristol
BS6 6JU
United Kingdom

Phone	+44 0117 973 1231
Email	elizabeth.thompson@ubht.swest.nhs.uk

Primary study design	Interventional
Study design	Pilot RCT
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Added September 2008: favourable ethical opinion from the Oxfordshire Research Ethics Committee B (UK) on 22/11/2005.
Health condition(s) or problem(s) studied	Respiratory: Asthma
Intervention	1. Homeopathy plus standard care 2. Standard care
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/11/2006

Participant type(s)	Patient
Age group	Child
Lower age limit	7 Years
Upper age limit	14 Years
Sex	Not Specified
Target sample size at registration	80
Key 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.
Key exclusion criteria	Children who are presently using homeopathy or who are too unwell to take part or refuse informed consent.
Date of first enrolment	01/12/2005
Date of final enrolment	30/11/2006

Bristol Homeopathic Hospital

Bristol
BS6 6JU
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2011		Yes	No