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临床试验/CTRI/2026/03/106776
CTRI/2026/03/106776尚未招募2 期

Evaluation of comparative efficacy of Tapasvini Churna and Brahmi Taila Shirodhara Versus Alprazolam in the Management of Stress-Associated Insomnia- A Randomized controlled trial

Dr Rajimunnisa Begam Shaik1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2026年3月25日最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
33
试验地点
1
主要终点
Insomnia remission, defined categorically as a score grade 2 (i.e 8-14 on the ISI)

研究概览

简要总结

Adequate sleep (Nidra) is one of the essential factors to lead a healthy life. Ayurveda mentioned three important facts to keep a person in healthy status as Aahara (diet), Nidra (Sleep) & Bramhacharya (Celibacy) are mentioned as three Upastambha (sub-supporting pillars)executing an important role in maintaining the health.1Insomnia is one of the most common forms of sleep disturbance, with a prevalence of 18–33% in India .2-4Almost 15% of insomnia patients suffer from daytime consequences such as fatigue and malaise, memory and concentration difficulties, mood disturbances and irritability, and behavioral problems such as hyperactivity and aggression.5,6Currently, the mainstay treatment for insomnia is a behavioral approach and psychological treatment complemented with medications.

Tranquilizers and sedatives, such as benzodiazepines (alprazolam) and barbiturates, are the first-line pharmacological treatment for stress insomnia, however, there are concerns about residual symptoms, such as excessive sedation, tolerance, addiction, and neurological toxicity after longer usage.7 The overall management of stress induced insomnia seems to be unsatisfactory in the conventional system of medicine, as health surveys also show that 1.6 million adults with stress induced insomnia in the United States opt for complementary and alternative therapies annually.8 Therefore, there is a growing need to evaluate the role of alternative therapies in the management of insomnia

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

入选标准

  • Between the age group 18 and 60 irrespective of gender Diagnosed with primary insomnia as per research diagnostic criteria for primary insomnia25 ISI score of more than 8 but less than 21 points (mild to moderate insomnia) Willing to participate and able to consent.

排除标准

  • who are not satisfy the inclusive data are excluded for this study comorbid psychiatric disorders and comorbid medical conditions.

结局指标

主要结局

Insomnia remission, defined categorically as a score grade 2 (i.e 8-14 on the ISI)

时间窗: 30 days

次要结局

  • Secondary outcome measures will be evaluated using work stress scale.(2 yrs)
  • secondary outcomes will be measures from work place stress scale (WSS) Interpreting Workplace Stress Scale Scores, Total score of 15 or lower: Chilled out & relatively calm. Stress isn’t much of an issue. Total score 16 to 20: Fairly low. Coping should be a breeze, but you probably have a tough day now & then. Still, count your blessings. Total score 21 - 25: Moderate stress. Some things about your job are likely to be pretty stressful, but probably not much more than most people experience & are able to cope with. Concentrate on what can be done to reduce items with the worst scores. Total score 26 - 30: Severe(30 days)

研究者

发起方
Dr Rajimunnisa Begam Shaik
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DRRajimunnisaBegam shaik

KLE SHRI KBM AYURVEDA MAHAVIDYALA,SHAHAPUR,BELAGAVI,KARNATAKA

研究点 (1)

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