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
Fifty patients with primary chronic insomnia will receive, two drops of a intranasal preparation in each nostril nightly before sleeping for six weeks. All patients will be asked to complete an Insomnia Severity Index (ISI) and the Pittsburgh Sleep Quality Index(PSQI) questionnaires before the start of the trial, after the first week and and after 6 weeks of treatment. Improvements in sleep and ISI and PSQI scores will be evaluated using SPSS 14 One way ANOVA test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016013126282N1
Registration date:2016-02-26, 1394/12/07
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-02-26, 1394/12/07
Registrant information
Name
Behjat Javadi
Name of organization / entity
Department of Traditional Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mash
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 3255
Email address
javadib@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-03-01, 1394/12/11
Expected recruitment end date
2016-11-01, 1395/08/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 18 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Regional Committee for Research Ethics, Mashhad University of Medical Sciences
Street address
Ghoreishi building, Daneshgah Street
City
Mashhad
Postal code
Approval date
2015-12-06, 1394/09/15
Ethics committee reference number
IR.MUMS.SP.1394.15
Health conditions studied
1
Description of health condition studied
Primary chronic insomnia
ICD-10 code
F51.0
ICD-10 code description
Nonorganic insomnia
2
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
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
2
Description
Timepoint
Method of measurement
Secondary outcomes
empty
Intervention groups
1
Description
Two drops of the combination of viola, saffron and lettuce oil in sesame oil base in each nostril every night before sleep
Category
Treatment - Drugs
2
Description
Two drops of sesame oil in each nostril every night before sleep
Category
Placebo
3
Description
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qaem hospital
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
School of pharmacy, Pardis university campus, Park square
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Traditional Pharmacy, School of pharmacy, Mashhad University of Medical sciences, Mash
Full name of responsible person
Dr. Behjat Javadi
Position
assistant professor(pharm.D.; Ph.D.)
Other areas of specialty/work
Street address
School of pharmacy, Pardis university campus, Park square
City
Mashhad
Postal code
Phone
+98 51 3882 3255
Fax
Email
javadib@mums.ac.ir; behjat.javadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Traditional Pharmacy, School of Pharmacy, Mashhad University of Medical sciences, Mash
Full name of responsible person
Dr. Behjat Javadi
Position
Assistant professor/ Pharm.D; Ph.D
Other areas of specialty/work
Street address
School of Pharmacy, Pardis University Campus, Park Square
City
Mashhad
Postal code
Phone
+98 51 3882 3255
Fax
Email
javadib@mums.ac.ir; behjat.javadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Traditional Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mash
Full name of responsible person
Dr. Behjat Javadi
Position
Assistant professor
Other areas of specialty/work
Street address
School of Pharmacy, Pardis University Campus, Park Square
City
Mashhad
Postal code
Phone
+98 51 3882 3255
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)