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The effect of Lactuca sativa seed oil on childhood insomnia

Explanation of insomnia from the viewpoint of Iranian Medicine and the evaluation of topical Lactuca Sativa oil in comparison with clonidin on insomnia of children between 3 to 6 years old, clinical trial study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170725035284N2
Enrollment
72
Registered
2018-05-24
Start date
2018-05-09
Completion date
Unknown
Last updated
2018-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: sleepndisorders. Condition 2: Insomnia. Sleep disorder Disorders of initiating and maintaining sleep [insomnias]

Interventions

Intervention group: Lettuce seed oil(7 drops as topical oil on forehead and temple one hour before sleep) plus clonidine placebo(soluble in water one hour before sleep) for 3 weeks. Control group: Pla

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 6 Years

Inclusion criteria

Inclusion criteria: Entry criteria: 3 to 6 years old children with primary or secondary insomnia (comorbid with anxiety, ADHD, MDD) diagnosed by psychiatrist; Received informed consent of their family

Exclusion criteria

Exclusion criteria: Exclusion criteria: other secondary insomnia like due to autism, Nacturia, Panic disorder, Apnea, Restless leg syndrome, Parasomnia, Bruxism acute disorder in need for special medical care; History of allergy or contact dermatitis, drug reaction, missing more than 2 doses of intervention, tendency to quit the study

Design outcomes

Primary

MeasureTime frame
Childhood Insomnia. Timepoint: Baseline, Third week. Method of measurement: BEARS Questionaire.

Secondary

MeasureTime frame
Side effects like Headache, Contact allergy. Timepoint: During the study, Third week. Method of measurement: Questionaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahdieh Ranjbar

Esfahan University of Medical Sciences

m_ranjbar@dr.com+98 31 3651 1384

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026