EUCTR2004-004004-20-GB进行中（未招募）1 期
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
niversity of Leeds0 个研究点目标入组 40 人开始时间: 2005年8月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
排除标准
- •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
- •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)
- •Cyclosporine
- •Oral contraceptives
- •Photoreactive agents
- •Anticonvulsants (carbamazepine, phenobarbitone, phenytoin)
- •Theophylline
- •Triptans (sumatriptan, naratriptan, rizatriptan, zolmitriptan, frovatriptan)
- •SSRIs (citalopram, fluoxetine, fluvoxamine, paroxetine, sertaline)
- •Psoralens, (oxsoralen, trisoralen, ciprofloxacin and tetracycline)
- •Antipsychotic drugs
- •Neuroleptic drugs
- •Cimetidine
- •Oral corticosteroids
- •Thyroid hormones
- •Immunosuppressive agents.
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