ArticleEvidence-based complementary and alternative medicine : eCAM2019
Sleep Promoting Effects of IQP-AO-101: A Double-Blind, Randomized, Placebo-Controlled Exploratory Trial.
Article in Evidence-based complementary and alternative medicine : eCAM, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03114696 (Double-blind, Placebo-controlled, Randomised Pilot Clinical Trial to Explore Benefit and Tolerability of IQP-AO-101 in Healthy Subjects With Sleep Complaints), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Double-blind, Placebo-controlled, Randomised Pilot Clinical Trial to Explore Benefit and Tolerability of IQP-AO-101 in Healthy Subjects With Sleep Complaints
Who cites it
2 citing papers in PubMed.
- Effects of Saffron Extract on Sleep Quality: A Randomized Double-Blind Controlled Clinical Trial.Nutrients · 2021Trial
- Clinical Efficacy and Tolerability of Lemon Balm (Nutrients · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe purpose of this study was to explore the clinical benefit and tolerability of IQP-AO-101 in healthy subjects with sleep complaints.
methodsThis double-blind, randomized, placebo-controlled trial involved fifty subjects with sleep complaints. Subjects with a Pittsburgh Sleep Quality Index (PSQI) score between 6 and 15 were randomized to receive either IQP-AO-101 or placebo for 6 weeks, following a run-in period of one week. Sleep parameters were assessed at baseline and after 1, 4, and 6 weeks using the modified Athens Insomnia Scale (mAIS). Subjects were also instructed to wear an activity tracker and keep a sleep diary during the study. Other questionnaires administered were the Frankfurt Attention Inventory (FAIR-2) and the Profile of Mood States (POMS-65). Blood samples for safety laboratory parameters were taken before and at the end of the study.
resultsAfter 6 weeks, subjects who consumed IQP-AO-101 reported significant improvements in mAIS scores compared with placebo, including mAIS total score (11.76 ± 6.85 vs 4.00 ± 4.80;
conclusionsIn this study, IQP-AO-101 was well tolerated and efficacious for promoting sleep and enhancing daytime performance in subjects with moderate sleep disturbances. CLINICAL
trial registrationThis trial is registered with ClinicalTrials.gov, no. NCT03114696.
Identifiers
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Registered trials
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