A randomised controlled Clinical study to evaluate the efficacy of Kantkaryadi Kwath And Jatamansyadi Kwath Churna in the management of Anidra With special reference to Insomnia
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1 The primary outcome of this study is to evaluate the effectiveness of Kantkaryadi Kwath in comparision to Jatamansyadi Kwath Churna in the treatment of insomnia. This will be assessed by measuring changes in the Athens Insomnia Scale (AIS) and Pittsburgh Sleep Quality Index (PSQI) scores, with the expectation of significant improvements in sleep quality and reduction in insomnia symptoms.
研究概览
简要总结
The concept of Nidra, as described in Traya Upstamabha by Aacharya Charak, underscores
the critical role of maintaining harmony to sustain individual health. Sleep is accorded equal
significance as "Aahara" (diet) and "Bramhacharya" (celibacy). These three actions must be
engaged in thoughtfully to preserve optimal health. Maharishi Charak elucidates that various
aspects of human existence including happiness, misery, growth, waste, strength, weakness,
virility, sterility, knowledge, ignorance, life, and death are all influenced by the quality of
sleep.
In the current era, characterized by intense competition and a constant chase for success, the
quality and patterns of sleep are frequently disturbed. Insomnia, defined as a lack of sufficient
and satisfactory sleep, is addressed in Ayurvedic texts under terms such as Nidranash,
Asavpna, and Anidra. According to Charak, Nidranash is categorized under ’vataj nanatamaj
vikar,’ whereas Sushrut attributes it to the aggregation of vata and pitta doshas.
Numerous studies demonstrate that sedatives significantly enhance sleep quality. Their long
term effectiveness is minimal, with various side effects and a high risk of dependency.
Consequently, there is an imperative need to manage insomnia effectively using natural
methods.
Numerous herbal formulations and procedures outlined in Ayurvedic texts present viable
approaches for the management of Anidra.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 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
- •1 Confirmed diagnosis of Anidra (Primary Insomnia) 2 Patient who meets the criteria for mild to moderate in assessment criteria.
- •3 Individuals of any gender, regardless of their socio-economic condition.
- •4 Subjects who are ready to take part in the study with their consent.
排除标准
- •1 Insomnia also known as Anidra caused by several disorders such as Madatyaya (alcoholism), Abhigyata(injury), and other systemic ailments.
- •2 Psychiatric patients receiving medical treatment.
- •Drug induced insomnia 3 Patients who are already on treatment for insomnia.
- •4 Pregnant and lactating women.
- •5 Chronic debilitating diseases.
结局指标
主要结局
1 The primary outcome of this study is to evaluate the effectiveness of Kantkaryadi Kwath in comparision to Jatamansyadi Kwath Churna in the treatment of insomnia. This will be assessed by measuring changes in the Athens Insomnia Scale (AIS) and Pittsburgh Sleep Quality Index (PSQI) scores, with the expectation of significant improvements in sleep quality and reduction in insomnia symptoms.
时间窗: 28 days
2 The proportion of patients exhibiting significant improvement in their scores on the
时间窗: 28 days
Athens Insomnia Scale (AIS) and the Pittsburgh Sleep Quality Index (PSQI)
时间窗: 28 days
次要结局
- Include improvements in emotional well-being, reduction in negative emotions, physical and mental growth, reduction in wasted(time and resources, increased strength, reduction in weakness, enhanced cognitive)
研究者
Dr Asha
INSTITUTE FOR AYURVED STUDIES AND RESEARCH