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Holy basil and sleep quality: grade C

Limited evidence. Direction: No effect.

C LimitedIndustry-fundedSubjective outcome onlyShort-term only

Educational guidance, not medical advice

Why this grade

Rubric condition met: C, direction none: one RCT with one positive secondary self-report outcome (AIS) against null RSQ, PROMIS-29 sleep disturbance and wearable-tracker measures, plus one symptom item on a scale not described as validated

The Holixer trial found a larger fall in Athens Insomnia Scale scores than placebo, a secondary outcome, but no between-group difference in restorative sleep, PROMIS-29 sleep disturbance or tracker-measured total sleep time, time in bed or sleep efficiency. The OciBest trial reported fewer self-rated sleep problems as one item of a symptom scale. Both trials are tied to the same extract maker, and the Holixer authors call for objective sleep measures. With one positive secondary outcome against several null measures, the grade shows no direction of benefit.

How we grade evidence

Studies this grade rests on

EffectMixedNo effectSize shows participants (n)2010201520202025RCTSaxena 2012, 2012: RCT, n = 150, result not recordedLopresti 2022, 2022: RCT, n = 100, result not recorded
each study this grade rests on, by publication year and design. Solid: effect versus the comparator; half-filled: mixed; hollow: no effect; dashed: result not recorded yet. Larger marks had more participants.
Show the numbers
StudyYearDesignParticipantsResult
Saxena 20122012RCT150result not recorded
Lopresti 20222022RCT100result not recorded

Efficacy of an Extract of Ocimum tenuiflorum (OciBest) in the Management of General Stress: A Double-Blind, Placebo-Controlled Study.

Saxena RC, Singh R, Kumar P. Efficacy of an Extract of Ocimum tenuiflorum (OciBest) in the Management of General Stress: A Double-Blind, Placebo-Controlled Study Evid Based Complement Alternat Med, 2012. PMID 21977056

Result not recorded
Design
Randomized, double-blind, placebo-controlled trial (6 weeks)
Sample
n = 150
Population
Adults with symptoms of general stress (two centers in Lucknow, India)
Funding
Funding not stated in the paper; three co-authors are at the Research and Development Centre of Natural Remedies, which developed OciBest

A randomized, double-blind, placebo-controlled trial investigating the effects of an Ocimum tenuiflorum (Holy Basil) extract (Holixer(TM)) on stress, mood, and sleep in adults experiencing stress.

Lopresti AL, Smith SJ, Metse AP. A randomized, double-blind, placebo-controlled trial investigating the effects of an Ocimum tenuiflorum (Holy Basil) extract (Holixer(TM)) on stress, mood, and sleep in adults experiencing stress Front Nutr, 2022. PMID 36185698

Result not recorded
Design
Randomized, double-blind, placebo-controlled, two-arm parallel-group trial (8 weeks)
Sample
n = 100
Population
Adults aged 18-65 experiencing stress for over a month and current sleep problems (PSS 14 or higher)
Funding
Natural Remedies Pty Ltd (maker of the Holixer extract), which also supplied the capsules

Search and history

Search (): (holy basil[tiab] OR tulsi[tiab] OR "Ocimum sanctum"[tiab] OR "Ocimum tenuiflorum"[tiab]) AND (sleep[tiab]) AND (randomized[tiab] OR placebo[tiab])

  • Graded C (proposed): Proposed in the monograph draft
  • C to C (approved): Editor sign-off November 13, 2026: grade matches the editor-approved final page