跳至主要内容
临床试验/CTRI/2024/01/062138
CTRI/2024/01/062138尚未招募2/3 期

A clinical study to compare the effect of murdhini taila with ksheerabala thailam in primary insomnia.

DrKeerthana Varghese1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年2月3日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
will be the change in severity of insomnia according to insomnia severity index scale

研究概览

简要总结

INCLUSION

1.Patients between the age group of 30-50 years irrespective of gender.

  1. Patients with primary insomnia for at least 1 month duration.

  2. Patients diagnosed with insomnia as per DSM IV with an ISI Score more than 15.

EXCLUSION

  1. Patients contraindicated for murdhini taila.

  2. Sleep disturbance due to narcolepsy, breathing-related sleep disorder, circadian

rhythm sleep disorder, or a parasomnia.

  1. Sleep disturbance occurring during the course of another mental disorder (e.g.,

major depressive disorder, generalized anxiety disorder, a delirium).

  1. Patients under medication for insomnia.

  2. Patients with alcohol dependence or drug dependency

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
30.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients between the age group of 30-50 years irrespective of gender.
  • Patients with primary insomnia for at least 1 month duration.
  • Patients diagnosed with insomnia as per DSM IV with an ISI Score more than 15.

排除标准

  • Patients contraindicated for murdhini taila.
  • Sleep disturbance due to narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, or a parasomnia.
  • Sleep disturbance occurring during the course of another mental disorder (e.g., major depressive disorder, generalized anxiety disorder, a delirium).
  • Patients under medication for insomnia.
  • Patients with alcohol dependence or drug dependency.

结局指标

主要结局

will be the change in severity of insomnia according to insomnia severity index scale

时间窗: 0 Screening ,diagnosis | Assessment with ISI and PSQI | 1-7th day procedure

次要结局

  • will be change in quality of sleep according to patient(reported PQSI.)

研究者

发起方
DrKeerthana Varghese
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DrKeerthana Varghese

AMRITA SCHOOL OF AYURVEDA

研究点 (1)

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