Primary insomnia patients were detected by a neurologist based on the diagnostic criteria in DSM-V.
The included patients were those whose illness had lasted at least three months and were willing to participate in a research project.
The patients were referred to the Clinic of Traditional and Complementary Medicine in Mashhad University of Medical Sciences. After obtaining informed consent, they were randomly divided into three groups: A, B, C. The three groups received three drops of almond oil or violet-almond oil or placebo on each nostril every night. Since the treatment of chronic insomnia cares about sleep hygiene, due to moral considerations and lack of deprivation of treatment in the placebo group, sleep hygiene instructions were presented to all the three groups based on the guidelines of the American Association sleep (AASM). Before and after 30 days of treatment, Pittsburgh Sleep Quality Index, Insomnia Severity, was completed by all patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015120125335N1
Registration date:2016-02-19, 1394/11/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-19, 1394/11/30
Registrant information
Name
Zohre Feyzabadi
Name of organization / entity
Faculty of Traditional and Complementary Medicine, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3855 2188
Email address
feyzabadiz@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of violet almond oil with almond oil and placebo in quality of sleep in patients with chronic insomnia
Public title
Comparing the effect of violet almond oil with almond oil and placebo in chronic insomnia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to cooperate; Having the pre-defined conditions of insomnia according to DSM-V-TR; Suffering from insomnia for at least 3 months; Being between 18 and 60 years old; Lack of physical diseases such as lung diseases, allergic rhinitis, cardiovascular, infectious diseases, cancer; Lack of mental illnesses such as depression, substance and drug abuse; Lack of neurological diseases such as Parkinson's and Alzheimer's disease; lack of sleep disorders like sleep apnea; lack of using drug and non-drug treatments for insomnia.
Exclusion criteria: Pregnant and lactating women; History of allergy to medicinal herbs; Side effects of drugs; Irregular use of medication or treatment discontinuation; unwillingness to continue cooperation for any reason.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
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
Mashhad University of Medical Sciences
Street address
Building Qureshi, Daneshgah Ave.
City
Mashhad
Postal code
Approval date
2015-12-09, 1394/09/18
Ethics committee reference number
IR.mums.fm.REC.1394.461
Health conditions studied
1
Description of health condition studied
chronic insomnia
ICD-10 code
F51.0
ICD-10 code description
Nonorganic insomnia
Primary outcomes
1
Description
sleep
Timepoint
Before the intervention and one month after intervention
Method of measurement
Pittsburgh questionnaire, Insomnia Severity Index questionnaire
Secondary outcomes
1
Description
Side effects
Timepoint
The end of study
Method of measurement
Questionnaire
Intervention groups
1
Description
In the first group of intervention, patients receive 3 drops of almond violet oil in each nostril every night before sleep for a duration of one month. Each drop contains 33 mg of the drug.
Category
Treatment - Drugs
2
Description
In the placebo group, patients receive 3 drops of placebo in each nostril every night before sleep for a duration of one month.Each drop contains 33 mg of the placebo.
Category
Placebo
3
Description
In the second group of intervention, patients receive 3 drops of sweet almond oil in each nostril every night before sleep for a duration of one month. Each drop contains 33 mg of the drug.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Traditional Medicine Clinic
Full name of responsible person
Zohre Feyzabadi
Street address
Faculty of Traditional and Complementary Medicine, East Razi Ave.
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Building Qureshi, Daneshgah Ave.
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
Faculty of Traditional and Complementary Medicine, Mashhad University of Medical Sciences
Full name of responsible person
Zohre Feyzabadi
Position
assistant professor of Iranian traditional medicine
Other areas of specialty/work
Street address
Faculty of Traditional and Complementary Medicine, East Razi Ave.
City
Mashhad
Postal code
Phone
+98 51 3855 2188
Fax
Email
feyzabadiz@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Traditional and Complementary Medicine, Mashhad University of Medical Sciences
Full name of responsible person
Zohre Feyzabadi
Position
assistant professor of Iranian traditional medicine
Other areas of specialty/work
Street address
Faculty of Traditional and Complementary Medicine, East Razi Ave.
City
Mashhad
Postal code
Phone
+98 518552188
Fax
Email
feyzabadiz@mums.ac.ir feyzabadi_8823@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Traditional and Complementary Medicine, Mashhad University of Medical Sciences
Full name of responsible person
Zohre Feyzabadi
Position
assistant professor of Iranian traditional medicine
Other areas of specialty/work
Street address
Faculty of Traditional and Complementary Medicine, East Razi Ave.
City
Mashhad
Postal code
Phone
+98 51 3855 2188
Fax
Email
feyzabadiz@mums.ac.irfeyzabadi_8823@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)