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
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Lemon verbena | Lemon verbena supplement administered at an estimated daily dose of 15mg/kg |
| DIETARY_SUPPLEMENT | Placebo | Placebo 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.