The efficacy of treatment with St Johns Wort for premenstrual syndrome (PMS)
| ISRCTN | ISRCTN31487459 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31487459 |
| Protocol serial number | UI04-6748 |
| Sponsor | University of Leeds (UK) |
| Funder | The Rosalind Bolton Bequest (UK) |
- Submission date
- 02/02/2009
- Registration date
- 03/04/2009
- Last edited
- 01/03/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Institute of Psychological Sciences
University of Leeds
Leeds
LS2 9JT
United Kingdom
| s.e.canning@leeds.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional single centre randomised double-blind placebo-controlled cross-over study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised, double-blind, placebo-controlled trial to test the efficacy of Hypericum perforatum (St Johns Wort) as a treatment for premenstrual syndrome (PMS) |
| Study objectives | 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). |
| Ethics approval(s) | Leeds (West) Research Ethics Committee approval obtained 23 June 2005 (ref: 04/Q1205/173) |
| Health condition(s) or problem(s) studied | Pre-menstrual syndrome (PMS) |
| Intervention | 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. |
| Intervention type | Drug |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Hypericum perforatum (St John's Wort) |
| Primary outcome measure(s) |
Improvement in premenstrual symptoms measured using the Daily Symptom Report, completed daily by the participants throughout the trial. |
| Key secondary outcome measure(s) |
1. Other mood questionnaires, completed at the end of each week throughout the trial: |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 41 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2005 |
| Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
LS2 9JT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
