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.
Conditions
Interventions
Trade Name: Jarsin 450mg
Product Name: St John's Wort
Product Code: SJW
Pharmaceutical Form: Tablet
INN or Proposed INN: Hypericin
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether St John's Wort is more beneficial than placebo supplements in relieving symptoms of PMS, using both subjective (daily symtpom checklists and self reports of depression, impulsivity, agression and anxiety levels) and objective measures (blood tests to measure hormone, neurotransmitter and cytokine levels, and response bias measures from an emotional Stroop task).;Secondary Objective: Secondary objectives include examining the relationship between serotonin levels, cytokine levels and PMS symptoms, determining whether there is a relationship between the use of SJW and both cytokine and serotonin levels and determining whether the symptom profiles of a clinical population are similar to, or differ from, those of self-referred research recruited women; Primary end point(s): The endpoint of the trial is the change in total premenstrual symptom scores on the daily PMS symptom checklist, with the secondary endpoints being the change in specific symptoms on the PMS symptom checklist, changes in aggression, impulsivity, depression, anxiety, cytokine, and serotonin levels. | — |
Countries
United Kingdom
Outcome results
None listed