“A randomized control trial to evaluate the efficacy of Vijaya Beej Tail Nasya in Anidra (Insomnia Disorder)â€
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1. APA level-2 sleep disturbance adult scale
研究概览
简要总结
This is a randomized, open, parallel-arm trial that will be conducted to assess and compare the safety and efficacy of Vijaya Beej tail Nasya with Zolpidem (5-10 mg.) in Anidra/ Nidranash (Insomnia) in 100 patients, who will be selected from 1 center in Uttarakhand. The primary outcome measure will be taken as given in APA LEVEL 2—Sleep Disturbance—Adult scale, Pittsburgh sleep quality index (PSQI), and symptoms of Anidra mentioned in Ayurvedic texts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient fulfilling DSM-V criteria for insomnia disorder (non-comorbid).
- •Patient fit for Nasya procedure.
- •Patient does not have a history of hypersensitivity to the drug used.
排除标准
- •Sleep-wake disorders other than Insomnia disorder like- Obstructive sleep apnea, Restless leg syndrome, Narcolepsy, Parasomnia, Circadian Rhythm disorder, REM sleep behaviour disorder, NREM Sleep arousal disorder.
- •Insomnia duration of less than a week (Transient Insomnia).
- •Patient having Insomnia along with any major chronic systematic disorder like- uncontrolled diabetes, uncontrolled hypertension, chronic pain, cancer, asthma, heart disease, GERD, Alzheimer’s disease, etc.
- •Patient having any major psychiatric disorder like- anxiety, depression, psychosis, schizophrenia, etc.
- •Patients taking medicines that can cause insomnia like.
- •SSRI (antidepressants-Prozac and Zoloft), Dopamine agonist, anti-convulsant, B-agonist, theophylline, etc.
- •Severe alcoholics.
结局指标
主要结局
1. APA level-2 sleep disturbance adult scale
时间窗: 4 time points: | T1: Baseline (at the time of admission) | T2: 10th day (after completion of 1st sitting of treatment) | T3: 2oth day (after completion of 2nd sitting of treatment) | T4:30th day (after completion of 3rd sitting of treatment)
2. Pittsburgh Sleep Quality Index (PSQI)
时间窗: 4 time points: | T1: Baseline (at the time of admission) | T2: 10th day (after completion of 1st sitting of treatment) | T3: 2oth day (after completion of 2nd sitting of treatment) | T4:30th day (after completion of 3rd sitting of treatment)
iii) Angamarda (Body ache)
时间窗: 4 time points: | T1: Baseline (at the time of admission) | T2: 10th day (after completion of 1st sitting of treatment) | T3: 2oth day (after completion of 2nd sitting of treatment) | T4:30th day (after completion of 3rd sitting of treatment)
iv) Bhram (Giddiness)
时间窗: 4 time points: | T1: Baseline (at the time of admission) | T2: 10th day (after completion of 1st sitting of treatment) | T3: 2oth day (after completion of 2nd sitting of treatment) | T4:30th day (after completion of 3rd sitting of treatment)
v) Shiro Gaurav (Heaviness)
时间窗: 4 time points: | T1: Baseline (at the time of admission) | T2: 10th day (after completion of 1st sitting of treatment) | T3: 2oth day (after completion of 2nd sitting of treatment) | T4:30th day (after completion of 3rd sitting of treatment)
vi) Jadyata (Stiffness)
时间窗: 4 time points: | T1: Baseline (at the time of admission) | T2: 10th day (after completion of 1st sitting of treatment) | T3: 2oth day (after completion of 2nd sitting of treatment) | T4:30th day (after completion of 3rd sitting of treatment)
vii) Apakti (Indigestion)
时间窗: 4 time points: | T1: Baseline (at the time of admission) | T2: 10th day (after completion of 1st sitting of treatment) | T3: 2oth day (after completion of 2nd sitting of treatment) | T4:30th day (after completion of 3rd sitting of treatment)
viii) Glani (Nausea)
时间窗: 4 time points: | T1: Baseline (at the time of admission) | T2: 10th day (after completion of 1st sitting of treatment) | T3: 2oth day (after completion of 2nd sitting of treatment) | T4:30th day (after completion of 3rd sitting of treatment)
3. Ayurvedic parameters of Anidra/nidranash-
时间窗: 4 time points: | T1: Baseline (at the time of admission) | T2: 10th day (after completion of 1st sitting of treatment) | T3: 2oth day (after completion of 2nd sitting of treatment) | T4:30th day (after completion of 3rd sitting of treatment)
i) Jrimbha (yawning)
时间窗: 4 time points: | T1: Baseline (at the time of admission) | T2: 10th day (after completion of 1st sitting of treatment) | T3: 2oth day (after completion of 2nd sitting of treatment) | T4:30th day (after completion of 3rd sitting of treatment)
ii) Tandra (Drowsiness)
时间窗: 4 time points: | T1: Baseline (at the time of admission) | T2: 10th day (after completion of 1st sitting of treatment) | T3: 2oth day (after completion of 2nd sitting of treatment) | T4:30th day (after completion of 3rd sitting of treatment)
次要结局
未报告次要终点