加纳玛斯亚迪胶囊与沙参治疗失眠症的临床随机对照试验

IF 1.7 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE

Journal of Ayurveda and Integrative Medicine Pub Date : 2025-07-01 DOI:10.1016/j.jaim.2025.101160

M. Manasa , Aswini Padmashali , Basavaraj R. Tubaki , Manisha

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引用次数: 0

摘要

背景失眠是常见的睡眠障碍之一。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。目的探讨阿育吠陀干预（Mamsyadi Ghana胶囊和saraswatharida）对失眠障碍的治疗作用。材料与方法50例符合失眠症诊断标准（DSM 5）的患者，年龄20 ~ 70岁，男女不限。随机分组，阿育吠陀组给予Mamsyadi Ghana胶囊500 mg， Saraswatharista 10 ml，餐后等量水，每天3次，连用30天。唑吡坦组患者给予唑吡坦片10 mg，每日1次，睡前服用。通过失眠严重程度指数（ISI）、匹兹堡睡眠质量指数（PSQI）、Epworth嗜睡量表（ESS）、睡眠日记参数、抑郁、焦虑和压力量表（DASS）、生活质量SF - 36问卷和UKU副作用评定量表进行评估。临床评估分别在基线、第15天和第30天进行。结果阿育吠陀干预治疗效果显著，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的大部分成分方面具有可比性。阿育吠陀治疗组因情绪问题导致的限制作用成分有较好的改善（p = 0.01）。组内分析显示两组均有改善。唑吡坦组不良反应5例，阿育吠陀组无不良反应。结论阿育吠陀治疗失眠症的效果与唑吡坦相当。阿育吠陀干预对患者的生活质量有较好的改善，且具有良好的安全性。Ctri注册号Ctri /2021/12/038809。

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

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.