CTRI/2022/03/041165尚未招募4 期
An Epidemiological Study of Atichinta (Stress) As A Risk Factor In COVID Times And A Pilot Study To Evaluate The Safety And Efficacy Of â??CannaReliefâ?? Stress Management Oil After Oral Consumption In Patients With Stress And Mild To Moderate Anxiety Disorder
Bombay Hemp Company0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •a)Voluntary patients clinically diagnosed for mild to moderate anxiety disorder between18 to 75 years of age.
- •b)Ability to consent to the study and able to read and write in English or local language.
- •c)Patients who are non-regular users of cannabis in any form (three times per week or more) and are willing to abstain for 1 week prior and during the study;
- •d)Patients receiving opioids and other concomitant anxiety medications must have as table dose for the last 15 days; to check with investigator.
- •e)Normal liver function (defined as aspartate aminotransferase 10-40 U/L and alanine aminotransferase 7-56 U/L)
- •f)Normal renal function (defined as serum creatinine level <133 µmol/L and Estimated Glomerular Filtration Rate (eGFR) equal or higher than 60)
- •g)Accepting not to use products with the same end benefit during the entire study duration.
- •h)Patients willing to stop alcohol, caffeine and nicotine consumption during the studyduration
- •Cooperating, ready to sign consent form and ready to comply with protocol procedures
排除标准
- •a)Patients with history of diagnosis of another sleep disorder other than anxiety
- •b)History of bipolar disorder, psychotic disorder, or post-traumatic stress disorder or current psychiatric disorder that requires medication
- •c)On-going clinical depression and generalized anxiety disorder
- •d)Previous serious adverse event or hypersensitivity to cannabis or cannabinoids;
- •e)Presence of significant cardiac disease (history of unstable ischemic heart disease, heart failure, severe and uncontrolled hypertension) that, in the opinion of the investigator, would put the patient at risk of a clinically significant arrhythmia or myocardial infarction;
- •f)Current substance use disorder evaluated by history
- •g)Life-time history of dependence on cannabis or diagnosis of cannabis use disorder
- •h)Life-time history of schizophrenia, bipolar disorder, or previous psychosis with or intolerance to cannabinoids;
- •i)Current suicidal ideation according to the Suicide Severity Rating Scale
- •j)Pregnant women tested positive in UPT and lactating women or women planning pregnancy during the trial period. Willing to ensure that they or their partner use effective contraception during the study period;
- •k)Current use of cannabis in any form more than 3 times per week or use of cannabinoid- based medications within 7 days of study entry and refusal to abstain for the duration of the study;
- •l)Positive history for cannabinoids at screening for other potential abuse substances (e.g., alcohol, cocaine, amphetamines and methamphetamines, unprescribed opioids);
- •m)For whom the Investigator considers that he/ she will not be compliant with study procedures.
- •n)Any clinically significant systemic or cutaneous disease, which may interfere with study procedures. Participation in another clinical trial within 30 days of screening visit
研究者
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