One of the most common disorder of patients who experience post traumatic stress disorder is sleep disorders such as night mare and insomnia. In this study we are going to know if prazocine has any efficacy on sleep disorder of patients who experince post traumatic stress disorder. Participants will be 100 male and female who are under 45 years old, without cardiac disease and substances abuse. they will be grouped randomly in three treatment groups for during 8-10 weeks: 1- first will take prazocine, second will take hydrocizine and last one will take placebo. Results will be compared according to Pittursburgs Sleep Quality Index before and after the treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012085341N1
Registration date:2011-04-13, 1390/01/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-04-13, 1390/01/24
Registrant information
Name
Parastou Sabzehee
Name of organization / entity
Hamadan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1828 5015
Email address
p.sabzeie@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center for behavioral disorders and substances abuse, Hamadan
Expected recruitment start date
2011-01-05, 1389/10/15
Expected recruitment end date
2011-12-05, 1390/09/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of efficacy of prazocin on patient with post traumatic stress disorder
Public title
Study of efficacy of prazocin on patient with post traumatic stress disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients who have post traumatic stress disorder, age under 45 year, absence of heart disease, not having history of substances abuses. Exclusion criteria: hypotension during treatment.
Age
From 18 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
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 committee of Hamadan university of medical sciences
Street address
Hamadan university of medical sciences
City
Hamadan
Postal code
Approval date
2011-01-22, 1389/11/02
Ethics committee reference number
پ/16/35/9/163573
Health conditions studied
1
Description of health condition studied
Post traumatic stress disorder
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder
Primary outcomes
1
Description
sleep disorders
Timepoint
with 3 months interval
Method of measurement
Pittursburgs Sleep Quality Index
Secondary outcomes
1
Description
sleep enhancement
Timepoint
with 3 months interval
Method of measurement
Pittursburgs Sleep Quality Index
Intervention groups
1
Description
first group: prazosine 1-5 mg for 8 weeks
Category
Treatment - Drugs
2
Description
second group: hydrocizine 10-100 mg for 8 weeks
Category
Treatment - Drugs
3
Description
third group: placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Psychiatrists
Street address
Pastor cross road
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Ghaliha
Street address
Vice Chancellor for Research, Hamadan University of Medical Sciences
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Dr Sabzehee
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
Farshchian Hospital, Hamadan University of Medical scienses
City
Hamadan
Postal code
Phone
+98 81 1828 5015
Fax
Email
p.sabzeie@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Sabzehee
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences
City
Hamadan
Postal code
Phone
+98 81 1828 5013
Fax
Email
p.sabzeie@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Sabzehee
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences
City
Hamadan
Postal code
Phone
+98 81 1828 5015
Fax
Email
p.sabzeie@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)