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 |
| Secondary identifying numbers | N0632177581 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 28/09/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr E A Thompson
Scientific
Scientific
Bristol Homeopathic Hospital
Cotham Hill
Bristol
BS6 6JU
United Kingdom
| Phone | +44 0117 973 1231 |
|---|---|
| elizabeth.thompson@ubht.swest.nhs.uk |
Study information
| Study design | Pilot RCT |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| 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 | 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 study start date | 01/12/2005 |
| Completion date | 30/11/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 14 Years |
| Sex | Not Specified |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Bristol Homeopathic Hospital
Bristol
BS6 6JU
United Kingdom
BS6 6JU
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Avon Primary Care Research Collaborative (UK) NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2011 | Yes | No |
