Clinical Trials Directory

Trials / Completed

CompletedNCT05476549

Effects of Lemon Verbena Extract Supplementation in Sub-ADHD Children

Effects of Lemon Verbena Extract Supplementation on Behaviour Mood and Cognitive Function in Sub-ADHD Children

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
140 (actual)
Sponsor
Northumbria University · Academic / Other
Sex
All
Age
8 Years – 17 Years
Healthy volunteers
Accepted

Summary

The aim of this study is to investigate the effects of 15 mg/kg lemon verbena, in comparison to placebo, on the attention deficit hyperactivity disorder (ADHD) type behaviour and cognitive function of children who do not have a diagnosis of ADHD, but who exhibit high scores (highest tertile) on ADHD behaviour parameters. Multiple aspects of mood will also be assessed. The proposed randomised, double-blind, placebo-controlled, parallel groups design methodology will assess the psychological effects of 15 mg/kg lemon verbena extract and a matched placebo prior to and after 4 and 8 weeks of supplementation. The trial will utilise the COMPASS cognitive assessment system (Northumbria University) and a range of mood measures during laboratory testing visits. Parents and children will also take part in a concomitant smartphone study, comprising the collection of the parent's assessment of the child's behaviour/cognitive function and the child's self-report of the same, plus their mood. These assessments will take place on Days -1, 14, 28, 42 and 56.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTLemon verbenaLemon verbena supplement administered at an estimated daily dose of 15mg/kg
DIETARY_SUPPLEMENTPlaceboPlacebo supplement containing carrier material only

Timeline

Start date
2022-08-04
Primary completion
2023-08-27
Completion
2023-08-27
First posted
2022-07-27
Last updated
2023-12-11

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT05476549. Inclusion in this directory is not an endorsement.