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

ISRCTN	ISRCTN42406364
DOI	https://doi.org/10.1186/ISRCTN42406364
Secondary identifying numbers	NUX018

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Randomised controlled open outcome study of treatment of menopausal symptoms by medical herbalists (pilot study)
Study hypothesis	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.
Condition	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	Greene Climacteric Scale
Secondary outcome measures	Measure Yourself Medical Outcome Profile (MYMOP2), Hot flush Visual Analogue Scale (VAS)
Overall study start date	01/01/2002
Overall study end date	30/12/2004

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	45
Total final enrolment	45
Participant 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
Participant 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.
Recruitment start date	01/01/2002
Recruitment end date	30/12/2004

286 Ashley Down Road

Bristol
BS7 9BQ
United Kingdom

University of Central Lancashire (UK)
University/education

Faculty of Health
Preston
PR1 2HE
England
United Kingdom

Email	adenham@uclan.ac.uk
"ROR"	https://ror.org/010jbqd54

Research organisation

National Institute of Medical Herbalists (UK) - Education Fund

No information available

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	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.