CTRI/2024/03/063740尚未招募4 期
Comparison of effectivity and adverse effects of two different doses of melatonin with zolpidem on insomnia in cancer patients: A prospective, comparative, interventional study
未提供1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2024年3月15日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Change in Pittsburgh sleep quality index score
研究概览
简要总结
Cancer patients with insomnia are identified with PSQI score > 5 HADS also measured at bseline. patients are randomized into 3 groups getting melatonin 3mg , melatonin 5mg, and zolpidem 5mg and assessed at 2 weeks, 4 weeks and 6 weeks PSQI and HADS measured
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 20 and 65 years Registered in Palliative Medicine Department Suffering from a histologically diagnosed cancer Patients with sleep disturbance with a score 5 or higher on Pittsburgh sleep quality index (PSQI) Patient giving written informed consent for this study Patient having adequate pain relief and no history of dyspnoea.
排除标准
- •Patients with previous psychiatric disorder Patients on any sedatives/ hypnotics Patients in anti-anxiety medications Patient on anti-psychiatric treatment Patient having language and communication difficulties Patients using any kind of sleeping aids Having used melatonin for last one month Pregnant and lactating women Patients having severe liver and renal dysfunction Â.
结局指标
主要结局
Change in Pittsburgh sleep quality index score
时间窗: baseline,2,4 and 6 weeks
次要结局
- Change in Hospital Anxiety Depression Score
研究者
SREEHARSH S
SAWAI MAN SINGH MEDICAL COLLEGE AND ATTACHED HOSPITAL JAIPUR
研究点 (1)
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