Effect of Pentoxifylline and Captopril combination therapy versus Captopril mono therapy on blood pressure control in patients with hypertension:Randomized clinical trial
Evaluation of blood pressure in Pentoxifylline and Captopril group
Evaluation of blood pressure in Captopril and placebo group
Compare blood pressure in Pentoxifylline and Captopril group with Captopril and placebo group
Design
Randomised controlled clinical trial, single blinded
Settings and conduct
This study is randomized clinical trial, which will done on total of 60 consented patients older than 18 years with diagnosis of stage 1 hypertension who attended the Shahid Madani clinic of Tabriz University of Medical Science and have indication of Captopril therapy according to standard treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of primary stage 1 hypertension according to JNC-7 guideline
Informed consent of patient
Exclusion criteria: Moderate and severe renal failure
liver failure
Contraindications of Captopril and Pentoxifylline
Patients with secondary hypertension
Pregnancy and lactation
Intervention groups
Patients in intervention group receive 400 mg extended release Pentoxifulline , 3 times a day plus 25 mg Captopril, 3 times a day orally for 2 months.
Patients in control group receive 25 mg Captopril and placebo 3 times a day orally for 2 months.
Main outcome variables
comparison of blood pressure level before beginning of study and two months after study, between two under study groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111206008307N31
Registration date:2019-04-27, 1398/02/07
Registration timing:registered_while_recruiting
Last update:2019-04-27, 1398/02/07
Update count:0
Registration date
2019-04-27, 1398/02/07
Registrant information
Name
Taher Entezari-Maleki
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
tentezarimaleki@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-08, 1398/01/19
Expected recruitment end date
2019-06-09, 1398/03/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Pentoxifylline and Captopril combination therapy versus Captopril mono therapy on blood pressure control in patients with hypertension:Randomized clinical trial
Public title
Effect of Pentoxifylline and Captopril combination therapy on blood pressure control in patients with hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of primary stage 1 hypertension according to JNC-7 guideline
Informed consent of patient
Exclusion criteria:
Moderate and severe renal failure
liver failure
Contraindications of Captopril and Pentoxifylline
Patients with secondary hypertension
Pregnancy and lactation
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed by permuted block randomization with a block size of 2 and an allocation ratio of 1:1 in two groups of intervention and control group.
Blinding (investigator's opinion)
Not 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 Ardabil University of Medical Sciences
Street address
University street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹۸۵۹۹۱
Approval date
2018-11-11, 1397/08/20
Ethics committee reference number
IR.ARUMS.REC.1397.129
Health conditions studied
1
Description of health condition studied
Primary hypertension
ICD-10 code
I1O
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Blood pressure
Timepoint
Measurement of blood pressure before intervention and two months after intervention
Method of measurement
Mercury Manometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group receive 400 mg extended release Pentoxifulline , 3 times a day plus 25 mg Captopril, 3 times a day orally for 2 months.All of the drugs used in this dtudy are generic and they do not have specific brand.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group receive 25 mg Captopril and placebo 3 times a day orally for 2 months.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Medical & Training Hospital
Full name of responsible person
Dr. Taher Entezari-Maleki
Street address
Daneshgah Street,Shahid Madani Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
-
Phone
+98 41 3335 7767
Email
afsaris@tbzmed.ac.ir
Web page address
https://madanihosp.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Shahab Bohlooli
Street address
Daneshgah Street
City
Ardabil
Province
Ardabil
Postal code
-
Phone
+98 45 3353 4776
Email
s.bohlooli@pharmacy.arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
50
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
2
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
آقای دکتر ابوالقاسم جویبان
Street address
Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
-
Phone
+98 41 3335 7310
Email
tentezari@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
50
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
Tabriz University of Medical Sciences
Full name of responsible person
Taher Entezari Maleki
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
University street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
-
Phone
+98 41 3337 2250
Email
tentezari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Taher Entezari Maleki
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Daneshgah Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
-
Phone
+98 41 3337 2250
Email
tentezari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Taher Entezari-Maleki
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
-
Phone
+98 413392593
Email
tentezari@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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All of the data of an article can be published after making patients unrecognized
When the data will become available and for how long
After publishing of article until 6 months after publishing of the results
To whom data/document is available
Data will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers that request data will be permitted only to doing analysis according to ethics for scientific aims
From where data/document is obtainable
Applicants can receive data by sending an E-mail to address of tentezari@gmail.com and get response from Dr. Taher Entezari Maleki
What processes are involved for a request to access data/document
After contacting with corresponding author(Dr.Taher Entezari Maleki), data will be sent to Tabriz Shahid Madani hospital ethics committee and after receiving permission data will be send to applicants