Randomised controlled open outcome study of treatment of menopausal symptoms by medical herbalists (pilot study)

ISRCTN	ISRCTN42406364
DOI	https://doi.org/10.1186/ISRCTN42406364
Protocol serial number	NUX018
Sponsor	University of Central Lancashire (UK)
Funder	National Institute of Medical Herbalists (UK) - Education Fund

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Julia Green
Scientific

286 Ashley Down Road
Ashley Down
Bristol
BS7 9BQ
United Kingdom

Phone	+44 (0)117 924 8133
Email	julia.green@ukonline.co.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Randomised controlled open outcome study of treatment of menopausal symptoms by medical herbalists (pilot study)
Study objectives	To demonstrate whether the well-being of a sample of menopausal women is improved by treatment from practicing medical herbalists.
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Menopausal symptoms or problems
Intervention	Intervention group of 15 women: 6 consultations and treatment with individual prescriptions of a mixture of herbal medicines over a 5 month period by one of 3 local qualified herbal practitioners who are Members of the National Institute of Medical Herbalists. Control group of 30 women: offered equivalent series of consultations and treatment after acting as controls for 5 months.
Intervention type	Other
Primary outcome measure(s)	Greene Climacteric Scale
Key secondary outcome measure(s)	Measure Yourself Medical Outcome Profile (MYMOP2), Hot flush Visual Analogue Scale (VAS)
Completion date	30/12/2004

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	45
Total final enrolment	45
Key inclusion criteria	1. Women aged 46 - 59 registered on database of one general practice in Bristol 2. Over three months since last menstrual period 3. Experiencing self-defined menopausal problems of over three months duration
Key exclusion criteria	In the previous three months: 1. Taken hormone replacement therapy 2. Taken any other hormone treatment including 'natural progesterone cream' 3. Taken tamoxifen 4. Surgery requiring a general anaesthetic Current: Complementary treatment for menopausal problems; psychiatric treatment or medication; advised by a doctor to take hormone replacement therapy because of osteoporosis or high risk of developing osteoporosis.
Date of first enrolment	01/01/2002
Date of final enrolment	30/12/2004

286 Ashley Down Road

Bristol
BS7 9BQ
United Kingdom

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/10/2007		Yes	No

28/10/2022: Total final enrolment added.