Purposes; the effect of N-acetylcysteine on quality of life, anxiety and antioxidant properties of cardiovascular patients. Design; this study is triple-blind clinical trial will that be done on 120 patients (in two groups: 60 patients in the intervention group and 60 patients in the control group).Procedures; before starting treatment, quality of life and anxiety will evaluate using the MacNew and Spillberger questionnaires in two groups.Intervention; the intervention and control groups will orally give with 600 mg n-acetyl cysteine and 600 mg placebo (respectively) twice a day for 30 days. The main outcome variables; quality of life and anxiety properties will assessed via the MacNew and Spillberger questionnaires. In addition, for evaluating the antioxidant biomarkers fasting blood sample will be taken from all three groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015121425526N1
Registration date:2016-02-01, 1394/11/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-01, 1394/11/12
Registrant information
Name
Hamzehe Najafia
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3222 2567
Email address
hamzehe_najafy@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Lorestan University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of N-acetylcysteine on the quality of life, anxiety and antioxidant indexes of patients with cardiovascular disease.
Public title
Effects of N-acetylcysteine on the quality of life, anxiety and antioxidant indexes of patients with cardiovascular disease.
Purpose
Supportive
Inclusion/Exclusion criteria
Criteria
1. patients with acute coronary syndrome, coronary artery disease, the treating physician to confirm the diagnosis reached.
2 people (women and men) aged 65-18 years able to read and write their own.
3. People who have the full consent to participate in research.
4. People who have a history of these-acetylcysteine orally, by injection or inhalation during the first months of treatment have not.
5 people without a history of hypersensitivity reactions after taking it approved acetylcysteine
6. The people who received both medications or substances with antioxidant effects as vitamin E, A or vitamin A, E, vitamin C, at least one month before the quake
7. People with a history of anti-anxiety drugs, have.
8 people aged 65-18 years.
9. The lack of disease HCV +, HBSAg +, HIV +, diabetes, kidney disease,
10 of pregnancy
Exclusion criteria
(1) patients who can not understand the questions or did not have the time and location aware.
2. Patients in the study were dissatisfied.
3. Patients who withdrew during the study.
4. People who do not consume drugs.
5 people who died during the study.
6. Individuals involved in the research program to improve the quality of life or reduce anxiety, such as health promotion, and rehabilitation and so on are.
7 people in the business week by experts and researchers to track the phone call not to participate or not.
8. ejection fraction less than 40% for the echocardiogram
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Lorestan University of Medical Sciences
Street address
Lorestan university of medical sciences,Khorramabad.Iran
City
Khorramadad
Postal code
11569689
Approval date
2015-11-08, 1394/08/17
Ethics committee reference number
lums.rec.1394.40
Health conditions studied
1
Description of health condition studied
cardiovascular disease
ICD-10 code
120-125
ICD-10 code description
Ischaemic heart diseases
2
Description of health condition studied
cardiovascular disease
ICD-10 code
120-125
ICD-10 code description
Ischaemic heart diseases
Primary outcomes
1
Description
quality of life
Timepoint
After and before of the intervention
Method of measurement
MacNew Questionnaire
2
Description
anxiety level
Timepoint
After and before of the intervention
Method of measurement
Spielberger Questionnaire
3
Description
blood antioxidant biomarker indexes
Timepoint
After and before of the intervention
Method of measurement
biochemical assesing
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group 1: oral administrations of 600MG N- acetyl cysteine (Avicenna Pharmacy Co.) twice a day for 30 days.
Category
Treatment - Drugs
2
Description
Control group: without drug treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam khominia hospital
Full name of responsible person
Hamzehe Najafi
Street address
Lorestsn-Poldokhtar- koye basijian
City
Poldokhtar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Shahin Raofi
Street address
Khorramabad, Lorestan, Iran
City
Khoramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan 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
Lorestan University of Medical Sciences
Full name of responsible person
Hamzehe Najafia
Position
Master student
Other areas of specialty/work
Street address
Emam Khomini hospital, Poldokhtar, Lorestan, Iran
City
Poldokhtar
Postal code
Phone
+98 66 3222 8225
Fax
+98 66 3222 8225
Email
hamzehe_najafy@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Hamzehe Najafia
Position
Master student
Other areas of specialty/work
Street address
Lorestan, Poldokhtar,Emam Kkomini Hospital
City
Poldokhtar
Postal code
Phone
+98 66 3222 8225
Fax
Email
hamzehe_najafy@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Emam khomini hospital of Poldokhtar
Full name of responsible person
Hmzeh Najafy
Position
nurse
Other areas of specialty/work
Street address
Lorestan, Poldokhtar, Iran
City
Poldokhtar
Postal code
Phone
+98 66 3222 8225
Fax
+98 66 3222 8225
Email
hamzehe_najafy@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)