ACTRN12624000828527尚未招募2 期
Exploring Medicinal Cannabis Effects on Endometriosis via Gut Microbiome Modulation: A Double-Blind Placebo-Controlled Clinical Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 42
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
- 18 Years 至 50 Years（—）
- 性别
- Female
入选标准
- •Aged 18-50 years.
- •Self-reported pelvic pain, severe enough to seek medical attention.
- •Diagnosis of endometriosis via laparscopy, MRI or ultrasound imaging by a medical doctor.
- •Residing in Sydney.
- •Regular menstruation (i.e. 21-35 day cycle)
- •Cannabis naïve or 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 products in a secure location and not to share/distribute cannabis to any other individual.
- •If sexually active and pregnancy is a possibility, agree to use appropriate contraception to prevent pregnancy during the study period.
- •Able to travel to a Laverty Pathology (or sister site) collection centre for two blood tests
- •Safety markers in full blood exam, liver and kidney function (as per blood tests) found within normal ranges.
- •Able to complete study questionnaires via invitations sent to email.
- •Willing to give informed consent to participate in the study.
排除标准
- •Not residing in Sydney.
- •Endometriosis-related surgery in the previous six months
- •Not experiencing regular menstruation (i.e. 21-35 day cycle)
- •Must not have started, stopped or had a significant dosage of any endometriosis-specific in the last three months including contraceptives, GNRH-a and neuroleptics (changes in ‘as needed’ medications such as analgesics are not reasons for exclusions).
- •Must not have any current or past diagnoses that would be considered a risk to participation in the study, including schizophrenia spectrum and other psychotic disorders, bipolar-related disorders, dissociative disorders, personality disorders, cannabis use disorder and obsessive-compulsive related disorders.
- •Currently have any major haematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, gastrointestinal (particularly hepatic), renal or neurological disease (determined by the medical monitoring team).
- •Has used cannabis in the past 3 months
- •Pregnant or planning to become pregnant during the study duration
- •Unwilling to use contraception for the duration of the study
- •Unable to travel to a Laverty Pathology (or sister site) collection centre for three blood tests
- •Full blood exam, liver and kidney function (including urea and electrolytes) safety markers not within normal ranges.
- •Current medical condition which in the opinion of the Principal Investigator or medical monitor is a contraindication for medicinal cannabis
- •Family history or personal history of drug dependence
- •Unwilling to complete study assessments via email.
- •Unwilling or unable to provide informed consent to participate in the study
研究者
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