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Evaluation of sedative effects of an Iranian Traditional Medicine intranasal dosage form containing saffron, lettuce seeds and sweet violet in primary chronic insomnia: A randomized, double blind controlled clinical trial

Evaluation of sedative effects of an Iranian Traditional Medicine intranasal dosage form containing saffron, lettuce seeds and sweet violet in primary chronic insomnia: A randomized, double blind controlled clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016013126282N1
Enrollment
50
Registered
2016-02-26
Start date
2016-03-01
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Condition 1: Primary chronic insomnia. Condition 2: . Nonorganic insomnia

Interventions

Intervention 1: Two drops of the combination of viola, saffron and lettuce oil in sesame oil base in each nostril every night before sleep. Intervention 2: Two drops of sesame oil in each nostril eve
Treatment - Drugs
Placebo
Two drops of the combination of viola, saffron and lettuce oil in sesame oil base in each nostril every night before sleep
Two drops of sesame oil in each nostril every night before sleep

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: willingness to participate; age between18 to 40 years old, and meeting the defined criteria for primary chronic insomnia according to ICSD-2. Exclusion criteria: being affected by physical diseases such as chronic heart failure, asthma, cancers, thyroid problems, hyperkalemia, renal failure; psychiatric diseases such as major depression, generalized anxiety disorders, psychosis;drugs abuse; other sleep disorders such as sleep apnea and restless foot syndrome; parallel usage of pharmacologic or nonpharmacologic treatment for insomnia; parallel usage of spironolactone; pregnant and lactating women; severe drug allergy; history of sever unusual drug reactions to herbs, and allergic rhinitis.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Changes in ISI and PSQI scores. Timepoint: At baseline, at the end of first week and at the end of six weeks of treatment. Method of measurement: ISI and PSQ questionnaires.;. Timepoint: . Method of measurement: .

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Behjat Javadi

Department of Traditional Pharmacy, School of pharmacy, Mashhad University of Medical sciences, Mash

javadib@mums.ac.ir; behjat.javadi@yahoo.com+98 51 3882 3255

Outcome results

None listed

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