“A randomized double-blind controlled clinical study to evaluate the efficacy of SDLSNT21 in the management of Nidranash (insomnia).â€
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Assessment on the basis of gradation of classical symptomes of Nidranash.
研究概览
简要总结
Insomnia is the disorder of initiation and/or maintenance of sleep where patient is having difficulty in initiating of sleep, difficulty in maintening sleep ( Frequent awakenings during the night, Early morning awakening.),Non restorative sleep where despite an adequate duration of sleep, there is sleep pattern as well as loss of quality and quantity of sleep.
Recent growth in digital media and smart phones has increased productivity expectations and blurred the line between work and personal life. All of these shortened free time, faster pace of life, and stress lead to sleep deprivation, which has serious implications for physical and mental health, job performance, and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having Classical Lakshana of Nidranash like Angamarda, Shirogaurava, Jrumbha, Jadyata, Glani, Bhrama, Apakti, Tandra.
- •Diagnosed case of insomnia made according to the guidelines mentioned in DSM-V for 3 month and above.
- •Patient ready to give inform consent and abide instruction.
排除标准
- •1 Patient below 20 years & after 60 years.
- •2 Insomnia secondary to Major mental disorders.
- •3 Pregnant and Lactating women.
- •4 Patient with RTA, Alcoholism.
- •5 Patient with drug dependency like anti-histamines and narcotics.
- •Patient with severe pain and orthopnea, Uncontrolled DM & HTN.
- •Patient having chronic illness like IHD, COPD, Malignancies and other Medical conditions.
结局指标
主要结局
Assessment on the basis of gradation of classical symptomes of Nidranash.
时间窗: At baseline,on 15th day and on 30th day.
次要结局
- Assessment on the basis of Pittsburgh Sleep Quality Index .(At baseline,on 15th day and on 30th day.)