This double-blinded clinical trial study aims to consider the effect of Violet Syrup on insomnia reduction in patients with depression or obsessive-compulsive disorder in Iran. Insomnia reduction will be considered using the Pittsburgh questionnaire. The inclusion criteria: sleeplessness score more than 5 based on Pittsburgh questionnaire, signs and symptoms of depression and obsessive-compulsive disorder, consent and commitment for participation in the study, consumption of SSIR drug for at least one month, no history of physical illnesses, psychotic psychiatric disorder and generalized anxiety disorder. Exclusion criteria: history of sleep apnea, use of pharmaceutical and non- pharmaceutical treatments for insomnia. The study population includes patients with depression or obsessive-compulsive disorder along with insomnia. . A total number of 80 patients with depression (20 patient in Violet Syrup and 20 patient in placebo Syrup) or obsessive-compulsive disorder (20 patient in Violet Syrup and 20 patient in placebo Syrup) will be randomly allocated to the intervention and control groups. In this research, the study subjects and data monitoring committee will be blinded. Patients in the study and control groups will receive Violet Syrup and placebo, respectively. The medication and placebo will not be manufactured by the researcher. Simple randomization of subjects will be provided using a random number table.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017040833294N1
Registration date:2017-09-26, 1396/07/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-26, 1396/07/04
Registrant information
Name
Maryam Shayesteh
Name of organization / entity
Iranian Traditional Medicine Department, Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 4055
Email address
m.shayesteh@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahed University
Expected recruitment start date
2017-09-15, 1396/06/24
Expected recruitment end date
2018-02-13, 1396/11/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of violet syrup on insomnia reduction in patients with obsessive compulsive disorder or depression
Public title
Assessment of Viola Odorata efficacy on insomnia in patients with obsessive compulsive disorder or depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: no history of psychotic psychiatric disorder and generalized anxiety disorder, no history of opiate using and neurological diseases such as Parkinson and Alzheimer, no sleep apnea, lack of simultaneous use of pharmaceutical and non- pharmaceutical treatments for insomnia, no pregnancy and lactation
Exclusion criteria: history of physical illness along with pulmonary diseases, rhinitis allergy, cardiovascular diseases, infectious diseases, hepatic and renal failure, cancers, psychiatric disorder and generalized anxiety disorder; history of smoking and opiate using, history of neurological diseases such as Parkinson and Alzheimer, sleep apnea, simultaneous use of pharmaceutical and non- pharmaceutical treatments for insomnia, pregnant and lactating women, drug avoidance for >20% of total dosage of prescribed drug
Age
From 16 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Ethics Commitee of Shahed University
Street address
Abdollahzadeh st, Keshavarz blv
City
Tehran
Postal code
Approval date
2017-04-09, 1396/01/20
Ethics committee reference number
IR Shahed REC.1395.232
Health conditions studied
1
Description of health condition studied
Obsessive Compulsive Disorder
ICD-10 code
F42
ICD-10 code description
Obsessive Compulsive Disorde
2
Description of health condition studied
Insomnia
ICD-10 code
F51
ICD-10 code description
Insomnia
3
Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Depression
4
Description of health condition studied
Insomnia
ICD-10 code
F51.9
ICD-10 code description
Insomnia
Primary outcomes
1
Description
Insomnia
Timepoint
Before intervention (baseline), after one month (post)
Method of measurement
Pittsburgh Questionnaire
Secondary outcomes
1
Description
Depression
Timepoint
Before intervention (baseline), after one month (post)
Method of measurement
Beck Questionnaire
2
Description
Obsessive Compulsive Disorder
Timepoint
Before intervention (baseline), after one month (post)
Method of measurement
YBOCS Questionnaire
Intervention groups
1
Description
Drug use syrup of violets to 5 ml every 12 hours in the morning and at night.
Category
Treatment - Drugs
2
Description
Placebo syrup use to 5 ml every 12 hours in the morning and at night.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatric Clinic of Imam Hossein
Full name of responsible person
Maryam Shayesteh (Physician, Student of Iranian Traditional Medicine)
Street address
Madani St
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Deputy of Research and Technology of Shahed University
Full name of responsible person
Dr. Zahra Kiasalari
Street address
Shahed University, Khalij Fars Express Way
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Deputy of Research and Technology of Shahed University
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Vice chancellor for research, Deputy of Research and Technology of Shahed University
Full name of responsible person
ٍEng. Mohamad Kamalinejad (pharmacist)
Street address
Near the Intersection of Niayesh, Vali Asr st
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Deputy of Research and Technology of Shahed University
Proportion provided by this source
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
Iranian Traditional Medicine Department, Shahed University