Effect of use of Valeriana Officinalis On psychological symptoms and sleep disorders in patient with chronic schizophrenia admitted in Sina hospital Jouneghan
Determination the effect of Valeriana Officinalis On psychological symptoms and sleep disorders in patient with chronic schizophrenia admitted in Sina hospital Jouneghan
Design
In this study, a double-blind, placebo-controlled clinical trial is a single-centered study, in which 80 patients with schizophrenia with inclusion criteria are divided into two groups. Inrervention group, in addition to routine drugs, one hour before bedtime, one capsule of sedamine and in control group, in addition to routine drugs capsule containing 50 mg of starch as a placebo receveive and after three months the therapeutic effects of the capsule of sodium will be examined.
Settings and conduct
Clinical trial; Sina Psychiatric Hospital; placebo-controlled
Participants/Inclusion and exclusion criteria
Inclusion criteria: Chronic schizophrenia based on physician diagnosis and diagnostic criteria DSM V
Exclusion criteria:The probable problems associated with the use of herbal medicines mentioned during the study; discharging and no possibility of participation in the study due to absence in the hospital
Intervention groups
Inrervention group, in addition to routine drugs, one hour before bedtime, one capsule of sedamine and in control group, in addition to routine drugs capsule containing 50 mg of starch as a placebo receveive and after three months the therapeutic effects of the capsule of sodium will be examined.
Main outcome variables
psychological symptoms and sleep disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120709010222N18
Registration date:2018-01-12, 1396/10/22
Registration timing:prospective
Last update:2018-01-12, 1396/10/22
Update count:0
Registration date
2018-01-12, 1396/10/22
Registrant information
Name
Zahra Keivani
Name of organization / entity
Shahrekord University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1222 0016
Email address
keivani@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of use of Valeriana Officinalis On psychological symptoms and sleep disorders in patient with chronic schizophrenia admitted in Sina hospital Jouneghan
Public title
Effect of use of Valeriana Officinalis On psychological symptoms and sleep disorders in patient with chronic schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic schizophrenia based on physician diagnosis and diagnostic criteria DSM V
Exclusion criteria:
The probable problems associated with the use of herbal medicines mentioned during the study
Discharging or no possibility of participation in the study due to absence in the hospital
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified Random Sampling
Blinding (investigator's opinion)
Double blinded
Blinding description
The investigator and the patient will have no information about the content of the capsules
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Kashani street, shahrekord university of medical sciences, shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
88187187
Approval date
2017-02-05, 1395/11/17
Ethics committee reference number
IR.SKUMS.REC.1395.250
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
psychological symptoms
Timepoint
Three weeks after intervention
Method of measurement
Anderson's Pittsburgh Questionnaires
2
Description
Sleep disorder
Timepoint
Three weeks after intervention
Method of measurement
Anderson's Pittsburgh Questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:every night, One hour befor bedtime, receive one capsule of 350mg sedemin per oral.
Category
Treatment - Drugs
2
Description
Control group: receive 50 mg capsule containing starch as a placebo per oral.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital Jouneghan
Full name of responsible person
Masoud Nikfarjam
Street address
Farsan city,3 km from Jangqan city
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
88187187
Phone
+98 38 2746 3331
Email
nikmas140@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Kamal Solati
Street address
Kashani street, shahrekord university of medical sciences, shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
88187187
Phone
+98 38 3334 2414
Email
kamal_solati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research of Shahrekord University of Medical Science
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Masoud Nikfarjam
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farsan city,3 km from Jangqan city,Sina hospital Jouneghan
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
88187187
Phone
+98 38 2746 3331
Email
nikmas140@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Nikfarjam
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farsan city,3 km from Jangqan city,Sina hospital Jouneghan
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
88187187
Phone
+98 38 2746 3331
Email
nikmas140@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Masoud Nikfarjam
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farsan city,3 km from Jangqan city,Sina hospital Jouneghan
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
88187187
Phone
+98 38 2746 3331
Email
nikmas140@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Innominate questionaire
When the data will become available and for how long
six months
To whom data/document is available
co authors
Under which criteria data/document could be used
publish
From where data/document is obtainable
co authors
What processes are involved for a request to access data/document
Six months from the time of the approval of the project to the publication of the documentation