Harit Mahesh Kumar, Mundhe Narendra, Tamoli Sanjay, Pawar Vinay, Bhapkar Vedvati, Kolhe Ganesh, Mahadik Swapnali, Kulkarni Anand, Agarwal Ankit
Department of Sanskrit Samhita Siddhant, DY (Dnyandeo Yashwantrao) Patil Deemed to be University School of Ayurveda, Navi Mumbai, IND.
Department of Kayachikitsa, KVTR (Karmvir Vyankatrao Tanaji Randhir) Ayurved College, Dhule, IND.
Cureus. 2024 Mar 20;16(3):e56530. doi: 10.7759/cureus.56530. eCollection 2024 Mar.
Background and objectives SIVI is a standardized extract prepared using the aerial parts of developed to enhance the quality of sleep. The objective of the present study was to the evaluate efficacy and safety of SIVI ( extract) in the management of stress and sleep problems in Indian participants in a randomized, double-blind, placebo-controlled, clinical study. Materials and methods A total of 65 participants with stress and insomnia were randomized to two groups with 32 in the SIVI ( extract) group and 33 in the placebo group. Subjects were asked to take the test substance along with water at bedtime for 30 days. The Perceived Stress Scale, quality of life using the General Health Questionnaire (GHQ-12) scale, and Insomnia Severity Index were assessed on day 1, day 15, and day 30. Results extract showed a statistically significant reduction in the mean score of stress on the Perceived Stress Scale and significantly increased the mean score of total sleep time compared to placebo. The general psychological health was found to be significantly improved in the SIVI ( extract) group compared to the placebo group on day 15 and day 30. SIVI ( extract) did not show any adverse effects. Conclusions The results of the current study indicate that extract is beneficial in the management of stress and helps to improve sleep quality in subjects with stress and insomnia.
SIVI是一种使用[植物名称]地上部分制备的标准化提取物，其研发目的是提高睡眠质量。本研究的目的是在一项随机、双盲、安慰剂对照的临床研究中，评估SIVI（提取物）对印度参与者应激和睡眠问题的管理效果及安全性。材料与方法：共有65名有应激和失眠问题的参与者被随机分为两组，SIVI（提取物）组32人，安慰剂组33人。受试者被要求在睡前用水服用受试物质，持续30天。在第1天、第15天和第30天评估感知应激量表、使用一般健康问卷（GHQ - 12）量表评估的生活质量以及失眠严重程度指数。结果：与安慰剂相比，[提取物名称]提取物在感知应激量表上的应激平均得分有统计学显著降低，总睡眠时间的平均得分显著增加。在第15天和第30天，与安慰剂组相比，SIVI（[提取物名称]提取物）组的总体心理健康状况有显著改善。SIVI（[提取物名称]提取物）未显示出任何不良反应。结论：本研究结果表明，[提取物名称]提取物在应激管理方面有益，有助于改善有应激和失眠问题受试者的睡眠质量。
