Compartion of effectiveness of valerian and melissa officinalis syrup and Alprazolam tablet on sleep quality and QOL in chronic heart failure patients.
The purpose of this study was to assess the effect of valerian and melissa officinalis syrup and Alprazolam tablet on sleep quality and QOL in chronic heart failure patients .The study was done as a randomized, double blind, with control group RCT. The inclusion criteria were: age older than 40 years, At least 6 score in the sleep quality questionnaire (PSQI) and the exclusion criteria were: lack of consent to continue participating in the study and sensitivity or physical problems to medicines during the study.160 patient divided into four groups. Interventions were included of prescription of three herbal drug in three intervention groups. The time of study was one month and then sleep quality and QOL were evaluated after one month intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204042289N2
Registration date:2012-04-05, 1391/01/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-05, 1391/01/17
Registrant information
Name
Fateme Aliakbari
Name of organization / entity
Nursing Midwifery School
Country
Iran (Islamic Republic of)
Phone
+98 38 1334 4912
Email address
aliakbari@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2010-03-01, 1388/12/10
Expected recruitment end date
2012-03-21, 1391/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compartion of effectiveness of valerian and melissa officinalis syrup and Alprazolam tablet on sleep quality and QOL in chronic heart failure patients.
Public title
Compartion of effectiveness of valerian and melissa officinalis syrup and Alprazolam tablet on sleep quality and QOL in chronic heart failure patient s in Hajar heart clinic of Shahrekord.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1-Suffering from CHF confirmed by patient's physician
2- The patients older than 40 years old
3- At least 6 score in the sleep quality questionnaire (PSQI)
The exclusion criteria :
1-Unwillingness to continue participating in the study
2-Exhibiting sensitivity or physical problems pertinent to medicines during the study.
Age
From 40 years old to 90 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
160
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
Shahrekord University of Medical Science Ethics Committee
Street address
Kashani street, Research assistance , Shahrekord University of Medical Sciences, Shahrekord, Iran.
40 patient in valerian group recived routine heart treatment with 12cc Valeriane officinalis syrup, an hour before going to bed every night within a month.
Category
Treatment - Drugs
2
Description
40 patient in secound group recived routine heart treatment with 12cc Melissa officinalis syrup, an hour before going to bed every night within a month.
Category
Treatment - Drugs
3
Description
40 patient in third group recived routine heart treatment with 12cc Melissa officinalis and valerian syrup(valeric), an hour before going to bed every night within a month.
Category
Treatment - Drugs
4
Description
40 patient in control group recived the routine heart treatment with Alprazolam tablet (from same institue) one hour before sleep for one month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital, Cardiology clinic
Full name of responsible person
Street address
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Research Assistant
Street address
Kashani street, Research Assistant, Univ of Medical Science, Shahrekord, Iran.
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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 University of Medical Sciences
Full name of responsible person
Aliakbari Fateme
Position
Student of Medicine
Other areas of specialty/work
Street address
Hezarjrib street, Midwifery Dept, Nursing and Midwifery Faculty, Univ of Medical Science, Isfahan, Iran.
City
Isfahan
Postal code
Phone
+98 38 1334 4912
Fax
Email
aliakbari@nm.mui.ac.ir; aliakbari@skums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
medical plant resaearch center
Full name of responsible person
Dr Mahmood Rafieian
Position
Professor
Other areas of specialty/work
Street address
Rahmatie, medical plant resaearch center, Shahrekord, Iran.
City
Shahrekord
Postal code
Phone
+98 38 1333 5652
Fax
+98 38 1333 5652
Email
rafieian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medical Plant Resaearch Center
Full name of responsible person
Dr Mahmood Rafieian
Position
Professor
Other areas of specialty/work
Street address
Rahmatie, medical plant resaearch center, Shahrekord, Iran.
City
Shahrekord
Postal code
Phone
+98 38 1333 5652
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)