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临床试验/CTRI/2024/03/064094
CTRI/2024/03/064094尚未招募2/3 期

Evaluation Of ashwagandha churna in management of childhood insomnia (Anidra) –A randomized controlled clinical trial

kle ayurveda hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年3月25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
30
试验地点
1
主要终点
There might be significant effect of Ashwagandha churna in the management of childhood insomnia.

研究概览

简要总结

Nidra (Sleep) being one of the Trayoupastambhas mentioned in Ayurveda; has uttermost importance in leading healthy and The prevalence of insomnia symptoms in girls is 16.3 % - 26.3%  in age group of 9 -16 years  and in boys age group of 9- 16 years the prevalence is 19%. Insomnia can also manifest as mood disturbance, irritability, emotional lability, depression, and anger; fatigue, increased somatic complaints, cognitive impairment, problem with memory, attention, concentration, decision- making, and problem solving, day time behaviour problems such as hyperactivity ,impulsivity, and noncompliance and academic problems,  chronic tiredness.Medications are frequently prescribed, but there is a lack of data from controlled studies to support the use of pharmacologic agents in the management of childhood insomnia.

Sedative of Benzodiazepines groups like Lorazepam, Alprazolam & Diazepam etc. on regular uses can cause severe withdrawal symptoms such as seizures, dependence & addiction. Hence there is a growing need for an alternative treatment modality.In Ayurveda there are several drugs which are known to be used for Anidra such as Ashwagandha and may be helpful in the management of childhood insomnia effectively. Therefore, this study is taken for the management of insomnia in children.

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
9.00 Year(s) 至 16.00 Year(s)(—)
性别
All

入选标准

  • Age group 9-16 years of both genders Children fulfilling the diagnostic criteria.

排除标准

  • Children with known case of sleep disorders like breathing related sleep disorder, pain conditions, urinary frequencies, asthma, malignancies, metabolic disorder etc.
  • Children with an acute or chronic, local or systemic infection will be excluded.
  • Children who are currently using other medications which may interfere with the outcome of the study will be excluded.
  • Children who have received any form of modern intervention for insomnia in last 2 months.

结局指标

主要结局

There might be significant effect of Ashwagandha churna in the management of childhood insomnia.

时间窗: 0th 15th 30th

次要结局

  • PSQI- Pitsburgh sleep quality index- Quality & Patterns of sleep(Assessment of Anidra as per Ayurveda parameters)

研究者

发起方
kle ayurveda hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Vinay Walunj

KLE Shri BMK Ayurveda Mahavidyalaya,Belagavi

研究点 (1)

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