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Nasal drop based on Persian medicine for insomnia treatment

Investigating the effect of a nasal drop based on Persian medicine for insomnia in depressed patients A randomized double-blind controlled clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250606066088N1
Enrollment
50
Registered
2026-05-11
Start date
2026-05-23
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Condition 1: depression. Condition 2: Insomnia. Major depressive disorder, single episode Insomnia not due to a substance or known physiological condition

Interventions

Intervention group: Drip a mixture of lavender, lemon balm, and poppy seed oils in a base of olive oil, two drops in each nostril, at night before bed for 4 weeks..

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients diagnosed with depression based on DSM-V criteria, confirmed by a psychiatrist Patients diagnosed with sleep disorders (insomnia) based on DSM-V criteria, confirmed by a psychiatrist Age range of 25 to 60 years Patients must be receiving standard psychiatric treatment Insomnia Severity Index (ISI) score greater than 8 but less than 21 Patients who voluntarily agree to participate in the study and sign a written informed consent form before the trial begins

Exclusion criteria

Exclusion criteria: Patients with serious underlying cardiovascular, liver, kidney, or hematopoietic diseases Insomnia caused by neurological disorders (e.g., stroke, Parkinson’s disease) History of sleep apnea Pregnant or breastfeeding women History of substance abuse History of allergy to herbal medicines Patient’s intolerance or unwillingness to continue treatment Patients not receiving standard psychiatric treatment for any reason

Design outcomes

Primary

MeasureTime frame
Insomnia score based on the Insomnia Severity Index (ISI) questionnaire. Timepoint: At the beginning of the study (before starting the intervention) and 14 and 28 days after starting the medication. Method of measurement: Insomnia Severity Index (ISI) questionnaire.;Sleep quality score based on the Pittsburgh Sleep Quality Index (PSQI) questionnaire. Timepoint: At the beginning of the study (before starting the intervention) and 14 and 28 days after starting the medication. Method of measurement: Pittsburgh Sleep Quality Index (PSQI) questionnaire.

Secondary

MeasureTime frame
Brain temperament score based on the Fattahi Brain Temperament Questionnaire. Timepoint: At the beginning of the study (before starting the intervention) and 14 and 28 days after starting the medication. Method of measurement: Fattahi Brain Temperament Questionnaire.;Depression score based on the Beck’s Depression Inventory (BDI) questionnaire. Timepoint: At the beginning of the study (before starting the intervention) and 14 and 28 days after starting the medication. Method of measurement: Beck’s Depression Inventory (BDI) questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactIraj Shooli

Shiraz University of Medical Sciences

iraj.shooli110@gmail.com+98 71 3230 5410

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026