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探索黑种草的一种专利油提取物对非恢复性睡眠的短期影响:一项随机、双盲、安慰剂对照的活动记录仪研究。

Exploring the short-term influence of a proprietary oil extract of black cumin () on non-restorative sleep: a randomized, double-blinded, placebo-controlled actigraphy study.

作者信息

Mohan M E, Mohan Mohind C, Prabhakaran Prathibha, Syam Das S, Krishnakumar I M, Baby Chakrapani P S

机构信息

Department of General Medicine, BGS Global Institute of Medical Sciences, Kengeri, India.

Centre for Neuroscience, Cochin University of Science and Technology, Cochin, Kerala, India.

出版信息

Front Nutr. 2024 Jan 15;10:1200118. doi: 10.3389/fnut.2023.1200118. eCollection 2023.

Abstract

BACKGROUND

(black cumin, or black seed) is popularly known as the seed of blessings in the Arab system of medicine. Though not widely recommended for sleep, a unique proprietary black cumin extract (BlaQmax®/ThymoDream™; BCO-5) has been shown to be helpful in the management of stress and sleep issues.

METHODS

This randomized, double-blind, placebo-controlled trial aimed to investigate the efficacy of BCO-5 on the sleep quality of volunteers characterized with a self-reported non-restorative sleep disorder. Healthy male and female participants ( = 70), aged 18-65 years (BMI 22-28 Kg/m) were randomized to either placebo or BCO-5 ( = 35/group). Both interventions were supplemented at 200 mg/day for seven days. Actigraphy and a validated restorative sleep questionnaire (RSQ-W) were used to monitor the influence of BCO-5 on sleep.

RESULTS

Compared to placebo, BCO-5 significantly improved sleep quality, as evidenced by both intra-group and inter-group analyses of the actigraphy data. The relative improvements observed were sleep efficiency (7.8%,  < 0.001), total sleep time (19.1%,  < 0.001), sleep onset latency (35.4%;  < 0.001), and wake-after-sleep-onset (22.5%;  < 0.001) compared with placebo. BCO-5 also improved sleep by 75.3% compared to baseline ( < 0.001) and by 68.9% compared to placebo ( < 0.001), when monitored by RSQ-W. BCO-5 was well-tolerated with no reports of side effects or toxicity.

CONCLUSION

BCO-5 significantly improved non-restorative sleep in seven days, indicating its potential role as a natural sleep aid.

摘要

背景

黑孜然(或黑籽)在阿拉伯医学体系中被誉为“祝福之籽”。虽然黑孜然未被广泛推荐用于改善睡眠,但一种独特的专利黑孜然提取物(BlaQmax®/ThymoDream™;BCO - 5)已被证明有助于应对压力和睡眠问题。

方法

这项随机、双盲、安慰剂对照试验旨在研究BCO - 5对自我报告有非恢复性睡眠障碍的志愿者睡眠质量的疗效。年龄在18 - 65岁(体重指数22 - 28 Kg/m)的健康男性和女性参与者(n = 70)被随机分为安慰剂组或BCO - 5组(每组n = 35)。两种干预措施均以每天200毫克的剂量补充,持续七天。使用活动记录仪和一份经过验证的恢复性睡眠问卷(RSQ - W)来监测BCO - 5对睡眠的影响。

结果

与安慰剂相比,BCO - 5显著改善了睡眠质量,这在活动记录仪数据的组内和组间分析中均得到证实。观察到的相对改善包括睡眠效率(7.8%,P < 0.001)、总睡眠时间(19.1%,P < 0.001)、入睡潜伏期(35.4%;P < 0.001)以及睡眠中觉醒时间(22.5%;P < 0.001),与安慰剂相比。当通过RSQ - W监测时,BCO - 5与基线相比睡眠改善了75.3%(P < 0.001),与安慰剂相比改善了68.9%(P < 0.001)。BCO - 5耐受性良好,未报告有副作用或毒性。

结论

BCO - 5在七天内显著改善了非恢复性睡眠,表明其作为天然助眠剂的潜在作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/52dc/10822901/b6e70991cac5/fnut-10-1200118-g001.jpg

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