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

• Published in: Frontiers in nutrition (Lausanne) Vol. 10; p. 1200118
• Main Authors: Mohan, M E, Mohan, Mohind C, Prabhakaran, Prathibha, Syam Das, S, Krishnakumar, I M, Baby Chakrapani, P S
• Format: Journal Article
• Language: English
• Published: Switzerland Frontiers Media S.A 15-01-2024
• Subjects: actigraphy; black cumin; insomnia; Nigella sativa; non-refreshing sleep; non-restorative sleep; Nutrition; thymoquinone; Nigella sativa; black cumin; actigraphy; non-restorative sleep; non-refreshing sleep; insomnia
• ISSN: 2296-861X; 2296-861X
• DOI: 10.3389/fnut.2023.1200118

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