A pilot patient cohort randomised controlled trial (RCT) of the effectiveness of an offer of treatment by a homeopath
| ISRCTN | ISRCTN02875421 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02875421 |
| Protocol serial number | Protocol v8 |
| Sponsor | University of Sheffield (UK) |
| Funder | Department of Health Training fellowship (UK) |
- Submission date
- 25/04/2007
- Registration date
- 09/06/2008
- Last edited
- 27/09/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Clare Relton
Scientific
Scientific
University of Sheffield
Health Services Research (HSR)
School of Health and Related Research (ScHARR)
3rd floor Regents Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
| c.relton@sheffield.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial. |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A pilot patient cohort randomised controlled trial (RCT) of the effectiveness of an offer of treatment by a homeopath |
| Study objectives | The objectives of the pilot study were to assess the following: 1. Willingness of patients to fill in questionnaires, consent to further questionnaires and consent to have data used 2. Willingness of participants to accept the intervention 3. Rate of compliance with the intervention 4. Suitability of the outcome measures chosen 5. Variance of the outcome variable 6. Changes in the health condition in the control group Estimates of these parameters, especially the variance, will be used to recalculate the sample size to ensure that any main trial has sufficient power. |
| Ethics approval(s) | South Sheffield NHS Research Ethics Committee. Date of approval: 30/01/2007 (ref: 06/Q2305/181) |
| Health condition(s) or problem(s) studied | Hot flushes |
| Intervention | Intervention group: Offer of a course of treatment by a homeopath. A series of between one to five appointments with a homeopath, the first consultation being around one hour and subsequent appointments being 20 - 30 minutes in duration. Control group: No treatment |
| Intervention type | Other |
| Primary outcome measure(s) |
Hot flush frequency and severity score at baseline and 36 weeks. |
| Key secondary outcome measure(s) |
The following outcomes were measured at baseline and 36 weeks: |
| Completion date | 01/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 50 |
| Key inclusion criteria | Participants for this trial were recruited from those participating in an observational study entitled "Women's Midlife Health Survey" conducted in Sheffield in 2005. The study was funded by a Research Capacity Development Award from the Department of Health. Inclusion criteria: 1. Female, aged 45-65 2. Fourteen or more hot flushes or night sweats per week, or self rating of hot flushes or night sweats as severe or very severe |
| Key exclusion criteria | 1. Taking Hormone replacement therapy (HRT) and not intending to stop 2. On immunosuppressant drugs 3. Currently undergoing chemotherapy |
| Date of first enrolment | 01/02/2007 |
| Date of final enrolment | 01/11/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University of Sheffield
Sheffield
S1 4DA
United Kingdom
S1 4DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 of pilot study | 01/09/2012 | Yes | No | |
| Other publications | study design | 19/03/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
27/09/2017: internal review.
