A Randomised, Double-blind, Placebo Controlled trial to test the efficacy of St John's Wort (Hypericum Perforatum) for Premenstrual Syndrome. - Testing the efficacy of St John's Wort (SJW) as a treatment for PMS
- Conditions
- The 'premenstrual syndrome' is a cyclical condition occurring 7-10 days before the onset of menstruation, and is relieved at, or shortly after commencement of menstrual flow. The most commonly reported symptoms include breast tenderness, bloating and cognitive complaints, such as poor concentration, confusion and forgetfulness, as well as depression, anxiety, irritability, and mood swings.
- Registration Number
- EUCTR2004-004004-20-GB
- Lead Sponsor
- niversity of Leeds
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
To qualify for inclusion in this study, a patient must satisfy all of the criteria listed below:
1. Written informed consent has been obtained prior to enrolment in the study.
2. The participant is female and aged between 18 and 45 years.
3. The participant is of good health, which will be assessed by the clinic doctor.
4. The participant has regular menstrual cycles, with a cycle length of 25-35 days.
5. The participant has PMS defined by at least a 30% increase in symptoms in the
luteal phase compared to the follicular phase.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Women will be excluded from the study for any of the following reasons:
1. Taking prescribed medication for PMS.
2. Taking OTC medication for PMS and unwilling to abstain for the duration of the
trial.
3. Using hormonal preparations, including oral contraception or Hormone
Replacement Therapy (HRT)
4. Is pregnant, planning pregnancy or lactating.
5. Has known photosensitivity.
6. Has depression or anxiety.
7. Taking:
•HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir)
•HIV non-nucleoside reverse transcriptase inhibitors (efavirenz, nevirapine)
•Warfarin
•Cyclosporine
•Oral contraceptives
•Photoreactive agents
•Anticonvulsants (carbamazepine, phenobarbitone, phenytoin)
•Digoxin
•Theophylline
•Triptans (sumatriptan, naratriptan, rizatriptan, zolmitriptan, frovatriptan)
•SSRIs (citalopram, fluoxetine, fluvoxamine, paroxetine, sertaline)
•Psoralens, (oxsoralen, trisoralen, ciprofloxacin and tetracycline)
•Lithium
•Antipsychotic drugs
•Neuroleptic drugs
•Cimetidine
•Oral corticosteroids
•Thyroid hormones
•Immunosuppressive agents.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method