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Mamsyadi Ghana胶囊和Saraswatarista在失眠症治疗中的疗效——一项随机对照临床试验

Efficacy of Mamsyadi Ghana capsule and Saraswatarista in the management of Insomnia Disorder - A Randomized Controlled Clinical Trial.

作者信息

Manasa M, Padmashali Aswini, Tubaki Basavaraj R

机构信息

Department of Kayachikitsa, Ramakrishna Ayurvedic Medical College, Hospital and Research Centre (RAMC). 54/2 Ramagondanahalli, Yelahanka, Bengaluru, Karnataka, 560064, India.

Dept of Psychiatry, USM KLE International Medical Programme, Belagavi, Karnataka, India.

出版信息

J Ayurveda Integr Med. 2025 Jul 8;16(4):101160. doi: 10.1016/j.jaim.2025.101160.

DOI:10.1016/j.jaim.2025.101160
PMID:40633355
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12274825/
Abstract

BACKGROUND

One of the prevalent sleep disorders is insomnia disorder. Current pharmacotherapy have limitations like dependence, tolerance and withdrawal effects. Ayurveda drugs remains to be explored.

OBJECTIVES

Can Ayurveda intervention (Mamsyadi Ghana Capsule and Saraswatharista) play a role in Insomnia disorder.

MATERIAL AND METHODS

50 patients meeting the diagnostic criteria of Insomnia Disorder (DSM 5), age group 20-70 years, either sex participated in the study. They were randomly divided and Ayurveda group received Mamsyadi Ghana Capsule 500 mg, Saraswatharista 10 ml, with equal quantity of water after food, both thrice a day for 30 days. Zolpidem group received tablet Zolpidem 10 mg once a day at bed time. Evaluations were done through Insomnia severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness scale (ESS), Sleep diary parameters, Depression Anxiety and Stress Scale (DASS), Quality of Life - SF 36 Questionnaire and UKU side effect rating scale. Clinical assessments were at baseline, 15th and 30th day.

RESULTS

The study showed that Ayurveda intervention produced significant improvement and was comparable to Zolpidem. Both interventions were comparable in ISI, PSQI, ESS, DASS scale, sleep diary parameters and most of the components of SF-36. Role of limitations due to emotional problems component showed better improvement in Ayurveda group (p = 0.01). Within group analysis showed improvement in both the groups. Five patients had adverse effects with Zolpidem and nil with ayurveda group.

CONCLUSIONS

The study showed that effect of Ayurveda interventions (Mamsyadi Ghana Capsule and Saraswatharista) is comparable to zolpidem in Insomnia Disorder. Ayurveda intervention had better improvement on quality of life and had good safety profile.

CTRI REGISTRATION NUMBER

CTRI/2021/12/038809.

摘要

背景

失眠症是一种常见的睡眠障碍。目前的药物治疗存在依赖性、耐受性和戒断效应等局限性。阿育吠陀药物仍有待探索。

目的

阿育吠陀干预措施(马姆西亚迪加纳胶囊和萨拉斯瓦塔里什塔)能否在失眠症中发挥作用。

材料与方法

50名符合失眠症诊断标准(DSM-5)、年龄在20至70岁之间、男女不限的患者参与了该研究。他们被随机分组,阿育吠陀组患者在饭后服用500毫克马姆西亚迪加纳胶囊、10毫升萨拉斯瓦塔里什塔,并饮用等量的水,均为每日三次,持续30天。唑吡坦组患者在睡前每日服用一次10毫克唑吡坦片。通过失眠严重程度指数(ISI)、匹兹堡睡眠质量指数(PSQI)、爱泼华嗜睡量表(ESS)、睡眠日记参数、抑郁焦虑压力量表(DASS)、生活质量-SF36问卷和UKU副作用评定量表进行评估。临床评估在基线、第15天和第30天进行。

结果

研究表明,阿育吠陀干预措施产生了显著改善,且与唑吡坦相当。两种干预措施在ISI、PSQI、ESS、DASS量表、睡眠日记参数和SF-36的大多数组成部分方面相当。由于情绪问题组成部分导致的局限性方面,阿育吠陀组显示出更好的改善(p = 0.01)。组内分析表明两组均有改善。5名患者使用唑吡坦出现不良反应,而阿育吠陀组无不良反应。

结论

该研究表明,阿育吠陀干预措施(马姆西亚迪加纳胶囊和萨拉斯瓦塔里什塔)在失眠症中的效果与唑吡坦相当。阿育吠陀干预措施对生活质量有更好的改善,且安全性良好。

CTRI注册号:CTRI/2021/12/038809。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/90c1/12274825/10e0e14cb57f/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/90c1/12274825/10e0e14cb57f/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/90c1/12274825/10e0e14cb57f/gr1.jpg

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本文引用的文献

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J Ayurveda Integr Med. 2024 Nov-Dec;15(6):100970. doi: 10.1016/j.jaim.2024.100970. Epub 2024 Nov 29.
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Effects of Mamsyadi Kwatha in primary insomnia - A randomized controlled trial.玛姆西亚迪药汁对原发性失眠的影响——一项随机对照试验
J Ayurveda Integr Med. 2023 Nov-Dec;14(6):100830. doi: 10.1016/j.jaim.2023.100830. Epub 2023 Nov 29.
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