In this study 40 referring women to heart clinics of Tabriz university of medical sciences with resistant HTN will be studied. All these women should be diagnosed with PMS according to DRSP test in 2 consequent months and should be included considering the inclusion & exclusion criteria and signing the written informed consent form . Screening the psychiatric patient will be also done according to SADS questionnaire ,Screening the psychiatric patient will be also done according to SADS questionnaire , all patient will be randomly divided into two control and intervention groups in a double blind study . the two groups will be matched regarding age and drug dosage . no patient will take extra anti-hypertensive drug . the intervention group will be treated by 50 – 100 mg sertraline for 4 – 6 weeks while the control group will be treated by placebo for the same time period . The blood pressure re control for both groups will be done by a 24 hour tonoport after 4 – 6 weeks . The results will be analysis by SPSS statistical program with paired samples T test and Independent samples T test
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904092181N4
Registration date:2010-06-30, 1389/04/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-06-30, 1389/04/09
Registrant information
Name
Fatemeh Ranjbar Kouchaksaraei
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 6923
Email address
ranjbarf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research of Tabriz University of Medical Sciences
Expected recruitment start date
2010-11-22, 1389/09/01
Expected recruitment end date
2011-11-22, 1390/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of sertraline in controlling the resistant hypertension in women with co-morbid premenstrual syndrome
Public title
The Effect of sertraline in women with resistant hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Sex age, Age 15 – 49 year old, presence of drug resistant hypertension, With PMS (premenstrual syndrome), With written informed consent form
Exclusion criteria: history of allergic reaction or side effect with sertaline, BMD (bipolar mood disorder), MDD (major depressive disorder), anxiety disorders, psychosis, cognitive disorders, or mental retardation, Pregnancy, breast feeding, Acute coronary syndromes, Heart failure
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
vice chancellor for research of tabriz university of medical sciences
Street address
Tabriz-golgasht streat-tabriz medical sciens univercity