NCT03108781

Brief Summary

Testing of Lavender Oil aromatherapy effect on behavior disorders in patients with severe dementia who are hospitalized in the ward for the mentally frail.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

April 18, 2018

Status Verified

October 1, 2017

Enrollment Period

7 months

First QC Date

March 26, 2017

Last Update Submit

April 17, 2018

Conditions

DementiaBPSD

Keywords

DementiaBehavioral Psychiatric symptomsTreatment

Outcome Measures

Primary Outcomes (1)

  • Behavioral symptoms

    Behavioral symptoms will be measured by Neuropsychiatric Inventory scale

    4 mounths

Study Arms (2)

Lavender Oil

ACTIVE COMPARATOR
Drug: Lavender OilDrug: sunflower oil

sunflower oil

PLACEBO COMPARATOR
Drug: Lavender OilDrug: sunflower oil

Interventions

Lavender OilDRUG

Lavender Oil twice a day; one month on the face and one month on the legs

Lavender Oilsunflower oil
sunflower oilDRUG

placebo twice a day (sunflower oil); one month on the face and on month on the legs

Lavender Oilsunflower oil

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients hospitalised in the mental frail wards of the "Mental Health Centre, Beer-Sheva".
  • Patients diagnosed with dementia (of all kinds).
  • Patients with informed consents from their guardians

You may not qualify if:

  • Patients without informed consent.
  • Patients with hypersensitivity to Lavender Oil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ben Gurion University

Beersheba, Israel

Location

Related Publications (1)

  • Ball EL, Owen-Booth B, Gray A, Shenkin SD, Hewitt J, McCleery J. Aromatherapy for dementia. Cochrane Database Syst Rev. 2020 Aug 19;8(8):CD003150. doi: 10.1002/14651858.CD003150.pub3.

    PMID: 32813272DERIVED

MeSH Terms

Conditions

Dementia

Interventions

lavender oilSunflower Oil

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Plant OilsPlant PreparationsBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of gariatric department

Study Record Dates

First Submitted

March 26, 2017

First Posted

April 11, 2017

Study Start

July 1, 2017

Primary Completion

February 1, 2018

Study Completion

September 1, 2019

Last Updated

April 18, 2018

Record last verified: 2017-10

Locations

IL(1)