Condition category
Urological and Genital Diseases
Date applied
12/07/2005
Date assigned
03/08/2005
Last edited
23/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Julia Green

ORCID ID

Contact details

286 Ashley Down Road
Ashley Down
Bristol
BS7 9BQ
United Kingdom
+44 (0)117 924 8133
julia.green@ukonline.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NUX018

Study information

Scientific title

Acronym

Study hypothesis

To demonstrate whether the well-being of a sample of menopausal women is improved by treatment from practicing medical herbalists.

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

Greene Climacteric Scale

Secondary outcome measures

Measure Yourself Medical Outcome Profile (MYMOP2), Hot flush Visual Analogue Scale (VAS)

Overall trial start date

01/01/2002

Overall trial end date

30/12/2004

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

45

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

Locations

Countries of recruitment

United Kingdom

Trial participating centre

286 Ashley Down Road
Bristol
BS7 9BQ
United Kingdom

Sponsor information

Organisation

University of Central Lancashire (UK)

Sponsor details

Faculty of Health
University of Central Lancashire
Preston
PR1 2HE
United Kingdom
adenham@uclan.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

National Institute of Medical Herbalists (UK) - Education Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in:
http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17698978

Publication citations

  1. Results

    Green J, Denham A, Ingram J, Hawkey S, Greenwood R, Treatment of menopausal symptoms by qualified herbal practitioners: a prospective, randomized controlled trial., Fam Pract, 2007, 24, 5, 468-474, doi: 10.1093/fampra/cmm048.

Additional files

Editorial Notes