Protocol summary

Summary
In this study all patients with urgency hypertension who admitted in urgency department of Shariati hospital in Isfahan were recruited .after interview by researcher ,if patients have consent to take part in study he or she will comes in study .After randomization by convenient way they will registered in one of these 2 groups ,First group (44 person) were managed by captopril bilingually and second group (44 person) were treated by clonidine and responses to treatment and any complications would be registered.all basic data similar to age,sex,other underling disease and other medications are registered by researcher as well.and finally all data would be analyzed by statistical sofetwere

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015122713828N7
Registration date: 2016-05-27, 1395/03/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-05-27, 1395/03/07
Registrant information
Name
Ahmad Mirdamadi
Name of organization / entity
Islamic Azad university ,Najafabad branch
Country
Iran (Islamic Republic of)
Phone
+98 31 1223 8028
Email address
drsamirdamadi@pmd.iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad university, Najafabad branch
Expected recruitment start date
2016-04-12, 1395/01/24
Expected recruitment end date
2016-09-14, 1395/06/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clonidine and captopril effects in reducing blood pressure in hypertensive urgency situation in 2016
Public title
Effect of clonidine in reducing blood pressure in hypertensive urgency situation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: emergency hypertension; patients' agreement to participate. Exclusion criteria: end organ damage; patients' non compliance; allergy to Clonidine or Captopril.
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
School of Medicine ,Isfahan University, Azad Square, Isfahan Isfahan Isfahan Iran, Islamic Republic Of 8174673441
City
Isfahan
Postal code
8174673441
Approval date
2016-04-12, 1395/01/24
Ethics committee reference number
495002

Health conditions studied

1

Description of health condition studied
Hypertension
ICD-10 code
I10-15
ICD-10 code description
Hypertensive diseases

Primary outcomes

1

Description
High Blood Pressure
Timepoint
15 minutes after treatment
Method of measurement
Sphygmomanometer

2

Description
Blood pressure
Timepoint
15 min after treatment
Method of measurement
Sphygmomanometer

Secondary outcomes

1

Description
Dry mouth
Timepoint
15 min after intervention
Method of measurement
Examination

2

Description
Headache
Timepoint
15 min after intervention
Method of measurement
Examination

3

Description
Dizziness
Timepoint
15 min after intervention
Method of measurement
Examination

4

Description
Palpitation
Timepoint
15 min after intervention
Method of measurement
Examination

5

Description
Cough
Timepoint
15 min after intervention
Method of measurement
Examination

6

Description
Angioedema
Timepoint
15 min after intervention
Method of measurement
Examination

Intervention groups

1

Description
Intervention 1: Clonidine 0.1 mg/ orally / stat
Category
Treatment - Drugs

2

Description
Intervention 2: Captopril 25 mg/ sub lingual/ stat
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Dr. Mirdamadi
Street address
Shariati hospital, Shariati street
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University, Najafabad branch,Isfahan
Full name of responsible person
Dr. Mirdamadi
Street address
Najafabad isfahan
City
Najafabad
Grant name
ندارد
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Najafabad branch,Isfahan
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
Medical School, Islamic Azad University, Najafabad Branc
Full name of responsible person
Dr. Ahmad Mirdamadi
Position
Cardiologist, Fellowship of Echocardiography, Assistant Professor of Medical Schoo
Other areas of specialty/work
Street address
update Heart Departement,Shariati Hospital,Isfahan
City
Isfahan
Postal code
Phone
+98 31 1223 8028
Fax
+98 31 1223 8028
Email
drsamirdamadi@yahoo.com/
Web page address
drsamirdamadi@pmd.iaun.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Najafabad Branch
Full name of responsible person
Ahmad Mirdamadi
Position
Cardiologist
Other areas of specialty/work
Street address
Isfahan,shariati street,shariati hospital
City
Isfahan
Postal code
Phone
+98 31 1223 8028
Fax
+98 31 1223 8028
Email
drsamirdamadi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Najafabad Branch
Full name of responsible person
Ahmad Mirdamadi
Position
Cardiologists
Other areas of specialty/work
Street address
Isfahan, shariati street, shariati hospital
City
Isfahan
Postal code
Phone
+98 31 1223 8028
Fax
+98 31 1223 8028
Email
drsamirdamadi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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