CTRI/2024/06/068682招募中2 期
Pilot Study to assess the efficacy of cannabinoid-rich Oral cannabis extract for pain management in cancer patients undergoing cancer directed treatment (surgery, systemic therapy, radiation therapy)and who have received systemic analgesics
Whole leaf Organics Pvt Ltd1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年6月30日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improvement in pain relief
研究概览
简要总结
Pilot Study to assess the efficacy of cannabinoid-rich Oral cannabis extract for pain management in cancer patients undergoing cancer directed treatment (surgery, systemic therapy, radiation therapy) and who have received systemic analgesics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients Histopathologically confirmed cancer diagnosis Moderate or severe pain Stable regime of pain management inclusive of NSAIDS weak opioid opioids Palliative intent therapy.
排除标准
- •Major psychiatric disorder Cardiovascular disorder Epilepsy Significant renal or hepatic impairment Pregnancy Lactating Women Patients who were currently using or had used cannabinoid based medications within 30 days of study entry.
结局指标
主要结局
Improvement in pain relief
时间窗: 90 Days
Using baseline assessment measures gathered at visit 0
时间窗: 90 Days
Screening assessments collected at visits 1 to 5 and follow up
时间窗: 90 Days
will be used to determine whether the administration of
时间窗: 90 Days
cannabinoid rich oral cannabis extract will improve pain relief
时间窗: 90 Days
in individuals with chronic pain Assessments will be made
时间窗: 90 Days
using a visual analogue scale
时间窗: 90 Days
次要结局
- Quality of life(Baseline 30 days 60 days 90 days)
研究者
Dr Manish Singhal
Indraprastha Apollo Hospitals New Delhi
研究点 (1)
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