The aim of this study is comparison of efficacy and patient satisfaction of oral and sub lingual captopril in hypertensive patient. This is double blind clinical trial study. Patients with systolic blood pressure ≥160 and diastolic blood pressure ≥100mmgh will be included and acute cardiac ischemia; pulmonary edema; loss of consciousness; acute renal failure and pregnancy will be excluded. After explaining the objectives of the study and obtaining the informed consent, patients randomized to random block 4-way A and B are divided two treatment group.one group with oral captopril and the second group with sub lingual captopril 25 mg will be treated. Systolic blood pressure, diastolic blood pressure, heart rate and patient satisfaction are study out comes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110924963N1
Registration date:2015-12-24, 1394/10/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-24, 1394/10/03
Registrant information
Name
Mania Armin
Name of organization / entity
Islamic Azad University Shahrood branch
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 0360
Email address
mania-armin@iau-shahrood.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrood Islamic Azad University
Expected recruitment start date
2015-12-06, 1394/09/15
Expected recruitment end date
2016-04-03, 1395/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and patients satisfaction of sub lingual and oral captopril patients with hypertension
Public title
Efficacy and patients Satisfaction of sub lingual and oral captopril in hypertensive patient
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion: blood pressure 160/100 and more than
exclusion: evidence of existence of acute ischemic heart disease; chest pain; dynamic change in EKG; heart failure; pulmonary edema; dissection of aorta; encephalopathy due to hypertension; seizure; loss of consciousness; cerebrovascular accident(ischemic , hemorrhagic); acute and chronic renal failure; history of pheochromocytoma; previous history of bilateral renal artery stenosis; pregnancy; hypertension after surgery; diastolic blood pressure >120; history of allergic reaction to captopril.
Age
No age limit
Gender
Both
Phase
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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences,Hafte Tir Square, Shahroud
City
Shahroud
Postal code
Approval date
2015-08-26, 1394/06/04
Ethics committee reference number
IR.SHMU.REC.1394.116
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Systolic Blood Pressure
Timepoint
10,20,30,45,60,90,120 min after drug administration
Method of measurement
blood pressure cuff, mmhg
2
Description
Diastolic Blood Pressure
Timepoint
10,20,30,45,60,90,120 min after drug administration
Method of measurement
blood pressure cuff, mmhg
3
Description
Pulse rate
Timepoint
10,20,30,45,60,90,120 min after drug administration
Method of measurement
Per Min
4
Description
Respiratory Rate
Timepoint
10,20,30,45,60,90,120 min after drug administration
Method of measurement
Per Min
Secondary outcomes
1
Description
Vomiting
Timepoint
after 2 hours
Method of measurement
Questionnare
2
Description
Headache
Timepoint
after 2 hours
Method of measurement
Questionnare
3
Description
Nausea
Timepoint
after 2 hours
Method of measurement
Questionnare
4
Description
Muscular Cramp
Timepoint
after 2 hours
Method of measurement
Questionnare
5
Description
cough
Timepoint
after 2 hours
Method of measurement
Questionnare
6
Description
Cutaneous Rash
Timepoint
after 2 hours
Method of measurement
Questionnare
Intervention groups
1
Description
Sub Lingual Captopril 25 mg, single dose
Category
Treatment - Drugs
2
Description
Oral Captopril, 25 mg, single dose
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Dr Nasrin Razavian Zadeh
Street address
City
Shahrod
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrood Islamic Azad University
Full name of responsible person
Dr Majid Salami
Street address
Tehran Blvd, Shahrood Islamic Azad University
City
Shahrood
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrood Islamic Azad University
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
Shahrood Islamic Azad Universty
Full name of responsible person
Mania Armin
Position
Medical Student
Other areas of specialty/work
Street address
Tehran Blvd, Shahrood Islamic Azad University
City
Shahrood
Postal code
Phone
+98 23 3239 0077
Fax
Email
mania_armin@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Internist,Shahrood Islamic Azad University
Full name of responsible person
Dr Nasrin Razavian Zadeh
Position
Internist
Other areas of specialty/work
Street address
Tehran Blvd, Shahrood Islamic Azad University
City
Shahrood
Postal code
Phone
+98 23 3239 0077
Fax
Email
nasrinrazavianzadeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Mehdi Musavi
Position
Cardiologist
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)