Effect of Chamomile on sleep quality of hemodialysis patient will determined. Iclussion Criteria: Having Consent form; Taking 5 points from Pitzbdurg test; Having at least 6 months dialysis experiences.
Exclussion Criteria:No tendency to continue the study; having reaction to Chamomile consumption.
The samles are 110 dialysis patients who come to Wali-e- Asr Hospital in Arak.The intervention group will take syrope of Chamomile 400 mg/Day at 21 to 22 Pm for 4 weeks. The conrol group will take syrope of Sakharin as the same. Quality of sleeping will measure at the begining and after the intervention.
General information
Acronym
Effect of Chamomile on Sleep Quality
IRCT registration information
IRCT registration number:IRCT2015051122218N1
Registration date:2015-06-12, 1394/03/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-12, 1394/03/22
Registrant information
Name
Vahid Moeini Ghamchini
Name of organization / entity
Neyshabour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4261 4062
Email address
v.moinighamchini@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Chamomile on Sleep Quality of Hemodialysis Patients
Public title
Effect of Chamomile on Sleep Quality of Hemodialysis Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Iclussion Criteria: Age between 18 to 65; Having Consent form; Taking 5 points from Pitzbdurg test; Having at least 6 months dialysis experiences; Not having bad enent during last 6 months; Having full awakeness and audio visual ability for learning Chamomile consumption
Exclussion Criteria:No tendency to continue the study; Suffering from each important diseases during the study; having reaction to Chamomile consumption; Having renal transplant; Pregnancy and feeding; No taking Chamomile for at least 3 days; Moving to other place or hospital and dying
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:
110
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
Arak University of Medical Sciences
Street address
Sardasht
City
Arak
Postal code
Approval date
2015-04-20, 1394/01/31
Ethics committee reference number
IR.ARAKMU.REC.1394.12
Health conditions studied
1
Description of health condition studied
End stage renal failure
ICD-10 code
n18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Quality of sleep
Timepoint
Monthly
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Anxiety
Timepoint
Weekly
Method of measurement
Questionnaire
Intervention groups
1
Description
The conrol group will take syrope of Sakharin at 21 to 22 Pm for 4 weeks.
Category
Treatment - Drugs
2
Description
The intervention group will take syrope of Chamomile 400 mg/Day at 21 to 22 Pm for 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valie Asr Hospital
Full name of responsible person
Vahid Moeini Ghamchini
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Mohammad Rafiei
Street address
Sardasht
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
Vahid Moeini Ghamchini
Position
Nurse
Other areas of specialty/work
Street address
Srdasht
City
Arak
Postal code
Phone
+98 86341736345
Fax
Email
v.moinighamchini@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
Sardasht
City
Arak
Postal code
Phone
+98 86 3417 3645
Fax
Email
v.moinighamchini@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
Vahid Moeini Ghamchini
Position
Master of Science in Nursing
Other areas of specialty/work
Street address
City
Arak
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)