The goal of this study is determination of the effect of Ducrosia Anethifolia on anxiety after myocardial infarction.
Inclusion criteria: Diagnosed MI based on cardiologist opinion; having no history of psychoneurosis disorders;
Exclusion criteria: having no ability to communicate with other; suffering from psychoneurosis disorders;
The study population was the patients hospitalized in Imam Khomaini hospital in Khomain which their MI was diagnosed by cardiologist.
Sample size was equal to 70 patients which were assigned into 2 groups with 35 samples randomly.
Intervention: Group1(intervention): Routine treatment + 100 mg of soft capsule (Perl) containing of the essence of Ducrosia Anethifolia two times in a day (6 am and 6 pm).
Group 2(control): Routine treatment + placebo (Perl) two times in a day (6 am and 6 pm).
Then the effect of Ducrosia Anethifolia on anxiety of the patients with myocardial infarction will determined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201302034519N5
Registration date:2013-02-23, 1391/12/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-23, 1391/12/05
Registrant information
Name
Davood Hekmatpou
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1417 3645
Email address
dr_hekmat@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2012-12-01, 1391/09/11
Expected recruitment end date
2013-03-01, 1391/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Ducrosia Anethifolia on anxiety of patients with acute myocardial infarction
Public title
Effect of Ducrosia Anethifolia on post myocardial infarction anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosed MI based on cardiologist opinion; ability and permitted to take oral tablet; having no history of psychoneurosis disorders; no treatment with antipsychotic drugs;
Exclusion criteria: having no ability to communicate with other; suffering from psychoneurosis disorders; treatment with antipsychotic drugs; inducing side effects or drugs interactions;
Age
From 45 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Arak University of Medical Sciences
Street address
Basij Sq. Arak
City
Arak
Postal code
Approval date
2012-10-08, 1391/07/17
Ethics committee reference number
91-134-8
Health conditions studied
1
Description of health condition studied
Myocardial Infarction
ICD-10 code
I20-I25
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
patient anxiety
Timepoint
Before intervention
Method of measurement
Spiel Berger questionnare
Secondary outcomes
1
Description
Patient anxiety
Timepoint
Before and after 48 hours
Method of measurement
Spiel Berger questionnare
Intervention groups
1
Description
Group 2(control): Routine treatment + placebo (Perl) two times in a day (6 am and 6 pm).
Category
Treatment - Other
2
Description
Group1(intervention): Routine treatment + 100 mg of soft capsule (Perl) containing of the essence of Ducrosia Anethifolia two times in a day (6 am and 6 pm).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomaini Hospital
Full name of responsible person
Dr. Davood Hekmatpou
Street address
Imam St.
City
Khomain
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Davood Hekmatpou
Street address
Basij Sq.
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr. Davood Hekmatpou
Position
Ph.D /Research Manager
Other areas of specialty/work
Street address
Basij Sq.
City
Arak
Postal code
Phone
+98 86 1417 3645
Fax
Email
dr_hekmat@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Davood Hekmatpou
Position
Ph.D in Nursing
Other areas of specialty/work
Street address
Basij Sq.
City
Arak
Postal code
Phone
+98 84173645
Fax
Email
dr_hekmat@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Davood Hekmatpou
Position
Ph.D/ Research Manager
Other areas of specialty/work
Street address
Basij Sq
City
Arak
Postal code
Phone
+98 86 1417 3645
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)