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
Secondary identifying numbers	Protocol v8

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

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

Email	c.relton@sheffield.ac.uk

Study information

Study design	Randomised controlled trial.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	Hot flush frequency and severity score at baseline and 36 weeks.
Secondary outcome measures	The following outcomes were measured at baseline and 36 weeks: 1. Euro Quality of Life questionnaire (EQ-5D) 2. Measure yourself Medical Outcome profile (MYMOP2; a quality of life measure) 3. Medication Change questionnaire 4. Health economics information regarding the following: 4.1. Number of hospital admissions 4.2. GP visits 4.3. Time taken off work 4.4. Loss of earnings 4.5. Impact of hot flushes on household activities 4.6. Special diets
Overall study start date	01/02/2007
Completion date	01/11/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	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

England
United Kingdom

Study participating centre

University of Sheffield

Sheffield
S1 4DA
United Kingdom

Sponsor information

University of Sheffield (UK)
University/education

University of Sheffield Research Office
New Spring House
231 Glossop Road
Sheffield
S10 3GW
England
United Kingdom

Email	g.pearman@sheffield.ac.uk
Website	http://www.shef.ac.uk
"ROR"	https://ror.org/05krs5044

Funders

Funder type

Government

Department of Health Training fellowship (UK)

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?
Other publications	study design	19/03/2010		Yes	No
Results article	results of pilot study	01/09/2012		Yes	No

Editorial Notes

27/09/2017: internal review.