CTRI/2023/01/048959招募中不适用
An Open Label Clinical Study to Evaluate the Safety and Efficacy of Hemp Seed Oil
Namrata Hempco Limited1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年1月16日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from Baseline to End of the Study in the Electroencephalogram Spike Activity
研究概览
简要总结
This is an open label single arm clinical study to evaluate the safety and efficacy of hemp seed oil in treating the epilepsy. The eligible subjects shall be administered with the 10 ml of hemp seed oil (5 ml in the morning and 5 ml in the night) everyday for 180 days.
研究设计
- 研究类型
- Interventional
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female subjects with epilepsy history, ranging in age from 18 to 45 years.
- •2.Willingness to follow the protocol requirements as evidenced by written, informed consent.
- •3.Mentally, physically and legally eligible to give informed consent 4.Willingness to complete study questionnaires.
排除标准
- •1.Patients with pre-existing other severe systemic disease necessitating long-term medication.
- •2.Significant medical or psychiatric illness 3.History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ 4.Any vascular or systemic disorder which could affect any of the efficacy assessments 5.Participation in the current or previous treatment with any approved or investigational health supplement(s) during the past 1 month 6.Subjects received other medication (anti-viral) within the 36 hours before entry into the study 7.Patients who had immunization against influenza or influenza like illnesses for that season.
- •8.Inability to comply with the study protocol, including psychiatric diseases 9.Immune compromised or with other clinically active illness including cardiac or pulmonary diseases, hemoglobinopathies, renal dysfunction 10.Having vaccination of a seasonal or new influenza A (H1N1) vaccine 6 months before 11.Other reasons that researchers think not fitting to participate in the study 12.Evidence of significant uncontrolled comorbid disease which in the investigator opinion would jeopardize patient participation 13.Patient tested positive with Covid 19.
结局指标
主要结局
Change from Baseline to End of the Study in the Electroencephalogram Spike Activity
时间窗: Day 0, Day 21, Day 42, Day 90, Day 120, Day 180
次要结局
- Number of attacks before and after treatment(Day 0, Day 21 and Day 42, Day 90, Day 120 and Day 180)
- Time to recover after onset of seizures(Day 0, Day 21 and Day 42, Day 90, Day 120 and Day 180)
- Percentage of patients reduced the attacks to nil by the end of the treatment period(Day 0, Day 21 and Day 42, Day 90, Day 120 and Day 180)
- Incidence of adverse events (AEs)(Day 0, Day 21 and Day 42, Day 90, Day 120 and Day 180)
- SGA/PGA(Day 0, Day 21 and Day 42, Day 90, Day 120 and Day 180)
研究者
研究点 (1)
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