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临床试验/CTRI/2021/04/032764
CTRI/2021/04/032764已完成3 期

A Comparative Clinical Evaluaion of Jatamaansi Taila Karnapoorana and Shiroabhyanga in Nidranasha W.S.R.to Insomnia

GOVERNMENT PG AYURVEDA COLLEGE AND HOSPITAL VARANASI UTTAR PRADESH1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年4月15日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Improvement in sleep quantity.

研究概览

简要总结

CLINICAL STUDY

SETTING:Patient suffering from nidranasha will be selected from OPD and IPD of government PG ayurveda college and hospital, choukaghat, varanasi, 221002.

Inclusion Criteria : Patients between age group 20-60 yrs, both gender,having clinical eatures of nidranasha

Exclusion criteria : mental disorders, ruptured eardrum, ear injury, patients ayogya of ahyanga

Grouping : 60 patients were randomly assigned in two groups

Group 1 -5ml of jatamaansi taila was poured in both ear one by one for 1000 vakamatra for 15 days.

Group 2 - 20ml of jatmaansi taila is massaged in head for 5 minutes daily, duration 15 days.

Follow up will be done on 15th day the treatment and 15 days after completion of treatment.

Statistical method of analysis : paired t test was used to know the efficacy of both karnapoorana and shiroabhyanga which came out to be highly significant in both treatment separately. Global PSQI score is the sum of all the seven components of PSQI, when the mean values are compared, the difference between them before treatment and after treatment came .93333 in group  A and 1.7333 in group B. It showed highly significant improvement, which indicates Jatamamsi taila karnapoorana and shiroabhyanga helps in producing highly significant improvement in Nidranasha.

For comparison of both groups unpaired t test was used which showed the 30 patients who had shiroabhyanga (PSQI M= 1.7333 SD = .44978) compared to the 30 patients who had karnapoorana (PSQI M = .9333 SD = .44978) demonstrated significantly better peak flow scores, t(104.163) = 3.247 , p-value = .003.

overall assesment: Group A: out of 60 patients, 3 patients got marked improvement,18 patients got moderate improvement and 9 patients with mild improvement were observed.

Group  B: out of 60 patients, 17 patients had marked improvement and 13 patients had moderate improvement.

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
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.difficulty in falling asleep, or maintaining sleep , or poor quality sleep.
  • If the sleep disturbances have occured 3 times a week for at least one month.
  • If the unsatisfactory quality and quantity of sleep either has caused distress or interferes with social and occupational functioning.

排除标准

  • 1.Any mental disorders.
  • 2.Patients on medications that interferes with normal quality of sleep.
  • 3.Insomnia due to other causes like that of madatyaya, abhighata, or systemic disease.
  • 4.Patients ayogya of abhyanga.
  • 5.Patients with ruptured eardrum, ear injury, or having any acute or chronic ENT disease or any inflammatory ENT disease.

结局指标

主要结局

Improvement in sleep quantity.

时间窗: 15 days

次要结局

  • NO RECURRENCE OF SIGNS AND SYMPTOMS(15 DAYS)

研究者

发起方
GOVERNMENT PG AYURVEDA COLLEGE AND HOSPITAL VARANASI UTTAR PRADESH
申办方类型
Research institution and hospital

研究点 (1)

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