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The efficacy of treatment with St Johnís Wort for premenstrual syndrome (PMS)
ISRCTN ISRCTN31487459
DOI 10.1186/ISRCTN31487459
ClinicalTrials.gov identifier
EudraCT number
Public title The efficacy of treatment with St Johnís Wort for premenstrual syndrome (PMS)
Scientific title A randomised, double-blind, placebo-controlled trial to test the efficacy of Hypericum perforatum (St Johnís Wort) as a treatment for premenstrual syndrome (PMS)
Acronym N/A
Serial number at source UI04-6748
Study hypothesis The primary objective of the proposed study is to determine whether hypericum perforatum (900 mg/day) is more beneficial than placebo supplements in relieving premenstrual symptoms in women diagnosed as having at least mild pre-menstrual syndrome (PMS).
Lay summary
Ethics approval Leeds (West) Research Ethics Committee approval obtained 23 June 2005 (ref: 04/Q1205/173)
Study design Interventional single centre randomised double-blind placebo-controlled cross-over study
Countries of recruitment United Kingdom
Disease/condition/study domain Pre-menstrual syndrome (PMS)
Participants - inclusion criteria 1. Women aged between 18 and 45 years
2. In good physical and psychological health (assessed by a clinician)
3. Regular menstrual cycles (25 - 35 days)
4. Experiencing at least a 30% increase in the total scale score on the Daily Symptom Report from their follicular (cycle days 5 - 10) to luteal (cycle days -6 to -1) phase in at least two out of three menstrual cycles
Participants - exclusion criteria 1. Using hormonal contraception or treatment
2. Pregnant or breast-feeding
3. Taking prescribed or over the counter medication for PMS
4. Taking prescribed drugs which could interact with Hypericum perforatum
5. Photosensitive
6. Meeting criteria for anxiety and/or depression
Anticipated start date 01/06/2005
Anticipated end date 01/01/2007
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 41
Interventions Random allocation to:
1. Hypericum perforatum tablets (900 mg/day)
2. Placebo tablets

After the three screening cycles, all women underwent a placebo run-in phase of two menstrual cycles, after which they were randomised to receive either Hypericum perforatum or placebo for two menstrual cycles. After a placebo-treated washout cycle, women were crossed over to placebo or Hypericum perforatum for a further two menstrual cycles.
Primary outcome measure(s) Improvement in premenstrual symptoms measured using the Daily Symptom Report, completed daily by the participants throughout the trial.
Secondary outcome measure(s) 1. Other mood questionnaires, completed at the end of each week throughout the trial:
1.1. State Trait Anxiety Inventory
1.2. Beck Depression Inventory
1.3. Aggression Questionnaire
1.4. Barratt Impulsiveness Scale
2. Hormone levels, measured during the follicular (days 5 - 10) and luteal (days -6 to -1) phases of study cycles 3 (screening), 5 (placebo run-in), 7 (treatment phase I: Hypericum perforatum or placebo), 8 (washout) and 10 (treatment phase II: placebo or Hypericum perforatum):
2.1. Follicle stimulating hormone (FSH)
2.2. Luteinising hormone (LH)
2.3. Oestradiol
2.4. Progesterone
2.5. Prolactin
2.6. Testosterone
3. Cytokine concentration, measured during the follicular (days 5 - 10) and luteal (days -6 to -1) phases of study cycles 3 (screening), 5 (placebo run-in), 7 (treatment phase I: Hypericum perforatum or placebo), 8 (washout) and 10 (treatment phase II: placebo or Hypericum perforatum):
3.1. Interleukin-1 beta (IL-1beta)
3.2. Interleukin-6 (IL-6)
3.3. Interleukin-8 (IL-8)
3.4. Interferon-gamma (IFN-gamma)
3.5. Tumour-necrotising factor-alpha (TNF-alpha)
Sources of funding The Rosalind Bolton Bequest (UK)
Trial website
Publications 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20155996
Contact name Dr  Sarah  Canning
  Address Institute of Psychological Sciences
University of Leeds
  City/town Leeds
  Zip/Postcode LS2 9JT
  Country United Kingdom
  Email s.e.canning@leeds.ac.uk
Sponsor University of Leeds (UK)
  Address Room 10.110
Level 10, Worsley Building
  City/town Leeds
  Zip/Postcode LS2 9JT
  Country United Kingdom
  Sponsor website: http://www.leeds.ac.uk/
Date applied 02/02/2009
Last edited 01/03/2010
Date ISRCTN assigned 03/04/2009
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