The comparison of the effect of N - acetylcysteine and angiotensin- converting enzyme inhibitors with angiotensin-converting enzyme inhibitors alone to control blood pressure in hypertensive patients referred to Hajar medical hospital
This study is to carry out to compare the effect of N - acetylcysteine and angiotensin- converting enzyme inhibitors with angiotensin-converting enzyme inhibitors alone to control blood pressure in hypertensive patients which aim to refer to Hajar hospital. In this study, 126 patients with systolic hypertension higher than 140mmHg are to be selected accessibly and to be randomly divided into two groups. The first group is to be prescribed NAC tablet with the doses of 600 mg dissolved in 30 cc water / 12 hours through taking along with ACEI for 2 months and the second group is to be treated with ACEI alone. Blood pressures of all patients is to be checked each 5-7 days. After that, for two weeks, none of the groups is to be received NAC and only is to be received ACEI. During this period as well, the blood pressure of the patients is to be measured every 5-7 days in medical clinics and after two weeks, the program is to be switched. i.e… for two months, the group previously take ACEI and NAC, is to be taken ACEI alone and the group which previously take ACEI , is to be treated with NAC and ACEI. Similar to the former two -months period, their blood pressure are to be checked every 5-7 days. The inclusion criteria: having age of 18 years old or more; systolic blood pressure of 140 mmHg or higher despite of taking ACEI. The people who are afflicted with Cystinuria; has kidney stones especially Cysteine stones; show severe sensitivity to ACEI and NAC and also the patients who need the other antihypertensive drugs besides ACEI to control their blood pressure are to be excluded from the study.
General information
Acronym
The effect of N - acetylcysteine and angiotensin converting enzyme inhibitors
IRCT registration information
IRCT registration number:IRCT2014022616750N1
Registration date:2014-04-21, 1393/02/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-21, 1393/02/01
Registrant information
Name
Mahmoud Mobasheri
Name of organization / entity
Shahrekord university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1334 2414
Email address
mobasheri@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research and technology , Shahrekord university of medical sciences , Shahrekord, Iran
Expected recruitment start date
2014-03-02, 1392/12/11
Expected recruitment end date
2014-04-22, 1393/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of N - acetylcysteine and angiotensin- converting enzyme inhibitors with angiotensin-converting enzyme inhibitors alone to control blood pressure in hypertensive patients referred to Hajar medical hospital
Public title
The comparison of the effect of N-acetylcysteine and angiotensin- converting enzyme inhibitors with angiotensin-converting enzyme inhibitors alone to control blood pressure in hypertensive patients
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria: having age of 18 years old or more; systolic blood pressure of 140 mmHg or higher despite of taking ACEI.
The people who are afflicted with Cystinuria; has kidney stones especially Cysteine stones; show severe sensitivity to ACEI and NAC and also the patients who need the other antihypertensive drugs besides ACEI to control their blood pressure are to be excluded from the study.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord, Medical Sciences University Of
Street address
Deputy of research and technology, central office of university of medical sciences, Kashani boulevard, Shahrekord
City
Shahrekord
Postal code
Approval date
2010-05-15, 1389/02/25
Ethics committee reference number
1-2-89
Health conditions studied
1
Description of health condition studied
Blood pressure
ICD-10 code
I10.0
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Blood pressure
Timepoint
Before the study, every 5-7 days during the study for two months
Method of measurement
Measured based on mmHg by Mercury barometer
Secondary outcomes
empty
Intervention groups
1
Description
The first group is to be prescribed NAC with the doses of the 600mg dissolved in 30cc water/12hrs along with ACEI for two months. The second group is to be treated with ACEI alone. During this two months , blood pressure of both groups is to be measured every 5-7 day. After that, none of each group will received NAC and only is to be taken ACEI.In this period also, the blood pressure is to be measured every 5-7 day. After two weeks, their program is to be switched.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
Dr.Arsalan Khaledi Far
Street address
Parastar street, Hajar hospital, Heart group
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research and technology, Shahrekord university of medical sciences
Full name of responsible person
Dr.Mahmoud Mobasheri
Street address
Kashani Boulevard, central office of university of medical sciences, deputy of research and technology
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research and technology, Shahrekord 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
Shahrekord,Medical Sciences University Of
Full name of responsible person
Dr.Mahmoud Mobasheri
Position
Associate professor of epidmiology group
Other areas of specialty/work
Street address
Department of epidmiology and statistics, faculty of health , university of medical sciences, Rahmatiye
City
Shahrekord
Postal code
Phone
+98 38 1334 2414
Fax
Email
mobasheri@skums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of cardiology
Full name of responsible person
Dr.Arsalan khaledi Far
Position
Cardiologist
Other areas of specialty/work
Street address
Parastar street
City
Shahrekord
Postal code
Phone
+98 38 1222 0016
Fax
Email
khaledifara@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hajar hospital
Full name of responsible person
Dr. Arsalan Khaledifar
Position
Cardiologist
Other areas of specialty/work
Street address
Parastar street
City
Shahrekord
Postal code
Phone
00
Fax
Email
khaledifara@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)