ACTRN12622001560785进行中（未招募）2 期
EndoCannED – The effect of Medicinal Cannabis on emergency department presentations in people with endometriosis: a randomised, controlled feasibility study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 20 Years 至 o limit（—）
- 性别
- Female
入选标准
- •Aged 20 years and over; able to read and write English fluently, be residing in the state of Victoria for the duration of the trial period, Diagnosis of endometriosis via laparoscopy, MRI or Ultrasound imaging by a medical doctor with input from an imaging specialist with specific endometriosis expertise; Have not used illicit cannabis or prescribed cannabinoid-based medications in the previous three months; Report no current, or history of, hazardous cannabis use or dependency; Agree to keep all study product stored in a secure location and not to share/distribute cannabis to any other individual; has access to a smartphone (either iOS or Android). If sexually active and pregnancy is a possibility, agree to use appropriate contraception to prevent pregnancy during the study period, agree not to consume alcohol during the titration and active phase of the trial, agree not to participate in any other clinical trial during the titration and active phase of the trial.
排除标准
- •Endometriosis-related surgery in the previous six months; Must not have started, stopped or had a significant change in dosage of any endometriosis specific medication in the last three months including contraceptives, GNRH-a, and neuroleptics (changes in ‘as needed’ medications such as analgesics are not reasons for exclusion); Upon review of medical or psychiatric history, must not have any current or past diagnosis that would be considered a risk to participation in the study, such as schizophrenia, psychosis, bipolar disorder, panic disorder, major depressive disorder, dissociative disorder, cannabis use disorder or obsessive-compulsive disorder; Currently have any major haematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, gastrointestinal (particularly hepatic), renal or neurological disease (determined by the medical monitoring team). Currently taking Immune modulators (e.g., cyclosporine), Mood-altering drugs (e.g., lithium carbonate) – not including antidepressants aside from tricyclics (mentioned below), Blood thinners (e.g., warfarin), Monoamine oxidase inhibitors (e.g., selegiline, phenelzine), Anti-arrhythmics (e.g., quinidine, disopyramide), Hypoglycaemics (e.g., insulin), Antiepileptics/anticonvulsants (e.g., phenytoin, valproic acid), Anti-HIV drugs (e.g., saquinavir), Antineoplastics (e.g., methotrexate), Barbiturates, Theophylline (1,3-dimethylxanthine), Cardiac glycosides (e.g., digoxin), St John’s wort. Known allergy to any of the compounds in the investigational products (e.g CBD, THC). Participation in another clinical trial during the past 30 days.
研究者
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