This is a randomized double blind study on 60 patients with heart failure referring to clinic; 30 patients in case group receive chamomile tea with standard treatment during 4 week and 30 patients in control group receive standard treatment only. Degree of dyspnea and anxiety will be studied using Beck questionnaire and dyspnea criteria. The data will analyze with average and standard deviation and be compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201308055866N11
Registration date:2014-04-26, 1393/02/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-04-26, 1393/02/06
Registrant information
Name
Akram Sanagoo
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1443 0360
Email address
sanagoo@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research & Technology, Golestan University of Medical Sciences
Expected recruitment start date
2014-04-30, 1393/02/10
Expected recruitment end date
2014-08-01, 1393/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of chamomile tea in dyspnea and anexiety on patients with chronic heart failure in the Jahrom country Honari clinic in 2014
Public title
The effect of Chamomile tea in dyspnea and anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: the alert patients that can have self care; non pregnant women; can to continue treatments during 4 week; age 18 to 80 years old; dyspnea due to heart failure; have glumerular filtration rate 90-120 ml/min; without asthma or chronic obstructive pulmonary disease; without reaction to use of chamomile tea; without acute or chronic heart failure with GFR under 90 ml/min.
Exclusion criteria: death; sensitivity to chamomile tea.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Golestan University of Medical Sciences
Street address
Golestan University of Medical Sciecens,Shastkol
City
Gorgan
Postal code
4934174515
Approval date
2014-03-16, 1392/12/25
Ethics committee reference number
39459200257
Health conditions studied
1
Description of health condition studied
Dyspnea
ICD-10 code
I50.9
ICD-10 code description
Heart failure, unspecified
2
Description of health condition studied
Anexiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Degree of anexiety
Timepoint
Previous,two seconds and four seconds after intervention
Method of measurement
Beck scale
2
Description
Severity of dyspnea
Timepoint
Previous,two seconds and four seconds after intervention
Method of measurement
VAS analyse scale
Secondary outcomes
empty
Intervention groups
1
Description
Group intervention:The patient in interventional group in addition to standard treatment three times daily use chammomile teathat diluted one tea bag in 50cc water100degree,in order physician use in form of palliative care.this therapy will continue four weeks in home.
Category
Treatment - Drugs
2
Description
Control group: standard heart failure therapy, including the use Diuretic, angiotensin enzyme inhibitors, beta-blockers and anxiolytic such as diazepam and midazolam
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Jahrom Honari clinic
Full name of responsible person
Zaynabsadat Fatah
Street address
Motahari Hospital
City
Jahrom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research & Technology, Golestan University of Medical Sciences
Full name of responsible person
Masood Khoshnia
Street address
Shastkola,Golestan University of Medical Sciences
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research & Technology, Golestan 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
Golestan University of Medical Sciences
Full name of responsible person
Massomeh Rahimi
Position
MS Student of Critical Nursing Care
Other areas of specialty/work
Street address
Golestan University Of Medical Sciences
City
Gorgan
Postal code
49165568
Phone
+98 17 1443 0360
Fax
+98 17 1442 5171
Email
rahimi.masome@gmail.com
Web page address
www.goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Akram Sanagoo
Position
PhD
Other areas of specialty/work
Street address
Golestan University of Medical Sciences, Shastkola
City
Gorgan
Postal code
49165568
Phone
+98 17 1443 0360
Fax
+98 17 1442 5171
Email
a_sanagu@yahoo.com
Web page address
www.Goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Golestan University Of Medical Sciences
Full name of responsible person
Masomeh Rahimi
Position
MS Nursing student
Other areas of specialty/work
Street address
Golestan University of Medical Science,shastkola
City
Gorgan
Postal code
49165568
Phone
+98 17 1443 0360
Fax
+98 17 1442 5171
Email
rahimi.masome@gmail.com
Web page address
www.Goums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)