CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
Reconnect +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02543203
NCT02543203Phase 2Completed

Essential Oils for Enhancing of Quality of Life in Autism Spectrum Disorder (ASD)

Jill Hollway·interventional·Posted Sep 7, 2015·Updated Apr 1, 2021

In Brief

A Phase 2 clinical trial evaluating Reconnect and Coconut oil Comparator for Autism Spectrum Disorder and 3 related conditions. Completed, enrolled 28 participants across 1 site.

Detailed Summary

Essential oils (aromatic oils extracted from plant parts) are routinely used by the public and are available on the market. Investigators are conducting this study because it is unknown whether the essential oils formulations will be safe and effective for improving quality of life in children with Autism Spectrum Disorder (ASD) by helping them relax and sleep. Children invited to participate in this study must be between 3-9 years of age and have been diagnosed with Autism Spectrum Disorder. Twenty eight children and their families will be enrolled in the study. Participants will try two different fragrant oils in a double-blind randomized order. Each child will receive each treatment for 3 months, with a 1-month "washout" period in between during which no oil is used.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 7, 2015
Enrollment StartJul 1, 2015
Primary CompletionMar 16, 2018
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 10.8 years ago

Interventions

Reconnectbiological

Topical Essential Oils mixture and aromatic method

Coconut oil Comparatorbiological

Topical Essential Oils mixture and aromatic method