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临床试验/CTRI/2026/01/101952
CTRI/2026/01/101952尚未招募2 期

Comparative Open Label Double Arm Clinical Trial to Study the efficacy of Lalata Basti and Lalata Pichu with Tungadrumadi Taila in Management of Nidranasha (Primary Insomnia)

SDM College of Ayurveda and Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年2月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
40
试验地点
1

研究概览

简要总结

Research from different parts of the world reveals that insomnia impacts a significant portion of the population usually between 10% - 30%, and sometimes even up to 50%- 60%. Also, about 4% of the population use sleeping pills in a regular basis. It has been found that 18.6% of the South India population are diagnosed with primary insomnia. Insomnia is characterized by a subjective difficulty in initiating or maintaining sleep, or experiencing non-restorative sleep, despite adequate time and environment for sleep leading to significant daytime dysfunction or distress.

Shirobasti is one among the Moordhnitaila, a Bahirparimarjana Chikitsa done over the Shiras. The Lalata Basti is conceptualized from Shiro Basti. In this sneha is made to retain over the forehead for a stipulated period of time. Lalata Basti is technically demanding due to the forehead’s curvature and the difficulty in retaining medicated oil effectively, it requires continuous monitoring to prevent leakage and maintain therapeutic temperature, making it labor-intensive. Whereas the proposed Lalata Pichu therapy minimizes procedural complexity while ensuring sustained local action of the medicated oil. It will allow uniform absorption of the drug without the need for complex setup or continuous monitoring

Tungadrumadi Taila is selected as it has Vatapittahara and Shitaveerya property. Ingredients of Tungadrumadi Taila are- Sugandha, Lamajja, Yashtimadhu, Utpala, Shvetachandana, Tungadruma, Dugdha and Tila

The present study is designed with the intent to evaluate the efficacy of Lalata Pichu as a potential alternative to Lalata Basti, considering its simpler application, minimal postural requirement, and resource optimization. If proven effective, Lalata Pichu may serve as a standardized Panchakarma intervention, thereby contributing to the clinical utility in managing Nidranasha.

研究设计

研究类型
Interventional
分配方式
Na
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 Subject fulfilling diagnostic criteria 2 Subject aging between 18-60 years 3 Subjects irrespective of gender 4 Subjects willing to sign informed consent form.

排除标准

  • 1 Known case of alcoholism 2 Known case of psychiatric illness 3 Subject suffering from ajeerna 4 Subjects receiving any medications that cause sedation.

研究者

发起方
SDM College of Ayurveda and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Swastika Chandel

Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital

研究点 (1)

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