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
Phase 2
Completed
- Conditions
- Condition 1: Primary chronic insomnia. Condition 2: .Nonorganic insomnia
- Registration Number
- IRCT2016013126282N1
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
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
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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: .
- Secondary Outcome Measures
Name Time Method