Evaluating the effect of formulated dill(Anethum graveolens) in a base of sesame oil on the factors related to the quality of life in hemodialysis patients
Purpose of study: Evaluating the effect of formulated dill(Anethum graveolens) in a base of sesame oil on the factors related to the quality of life in hemodialysis patients; Triple-blind, randomized, placebo-controlled trial, multi center; Inclusion:volunteered to participate in the study; age over 18; Undergoing hemodialysis for at least three month; not having any other cutaneous problem except Uremic pruritus; having gotten at least three at VAS scale; the absence of liver problems; not any allergy to oils.exclusion: If the patient receive renal transplant during the study; allergy to oils; tending to use other methods to reduce itching; The study population: all the hemodialysis patient; the sample size: 110 patients that are separated into 3 groups of 37 patient; intervention: using 2.5 gr of formulated dill(Anethum graveolens) in a base of sesame oil twice a day for a month topically; control: using 2.5 gr of sesame oil twice a day for a month topically; without intervention: just questionnaire should be answered; intervention time: Measurement of pruritus severity, quality of life and quality of sleep will be carried out before, two weeks and one month after intervention; outcome: treatment or reduction of itching, recovery of sleep disorders and improvement of hemodialysis patiens's life quality.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017022032671N1
Registration date:2017-05-07, 1396/02/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-07, 1396/02/17
Registrant information
Name
Zeinab Shaki
Name of organization / entity
Faculty of Nursing and Midwifery Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 6641 8587
Email address
z.shaki@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahed University, researcher:Zeinab shaki
Expected recruitment start date
2017-04-09, 1396/01/20
Expected recruitment end date
2017-10-12, 1396/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of formulated dill(Anethum graveolens) in a base of sesame oil on the factors related to the quality of life in hemodialysis patients
Public title
The effect of dill(Anethum graveolens) in the treatment of Uremic pruritus of hemodialysis patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion:volunteered to participate in the study; age over 18; Undergoing hemodialysis for at least three month; not having any other cutaneous problem except Uremic pruritus; having gotten at least three at VAS scale; the absence of liver problems; not any allergy to oils.exclusion: If the patient receive renal transplant during the study; allergy to oils; tending to use other methods to reduce itching.
Age
From 18 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)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahed University
Street address
First of Tehran_Qom free way, in front of Imam Khomeini(ra)'s holy shrine
City
Tehran
Postal code
3319118651
Approval date
2017-02-18, 1395/11/30
Ethics committee reference number
IR.Shahed.REC.1395.197
Health conditions studied
1
Description of health condition studied
Uremic pruritus
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease/ stage 5
Primary outcomes
1
Description
Uremic pruritus
Timepoint
Before, two weeks and one month after intervention
Method of measurement
VAS questionnaire; DUO questionnaire
Secondary outcomes
1
Description
Sleep disorder
Timepoint
Before, two weeks and one month after intervention
Method of measurement
PSI questionnaire
2
Description
quality of life
Timepoint
Before, two weeks and one month after intervention
Method of measurement
Itchy QOL questionnaire
Intervention groups
1
Description
Without intervention؛ for this group of patients only routine measures is done.
Category
Treatment - Other
2
Description
control group;
medication Sesame Oil;
Dosage: 2.5 gr, twice a day, topically,
during one month.
Category
Treatment - Drugs
3
Description
intervention group؛ formulated dill(Anethum graveolens) in a base of sesame oil. Dose: 2.5 gr، twice a day;topically; during a month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
5azar Medical and Educational Center, Hemodialysis Department
Full name of responsible person
Mr.Kashiri
Street address
5azar Blvd., 5azar St.
City
Gorgan
2
Recruitment center
Name of recruitment center
Ghaem (as) hospital,Hemodialysis Department
Full name of responsible person
Mr.Zangane
Street address
Imam Reza(as) St.
City
Ali Abad katul
3
Recruitment center
Name of recruitment center
Shahid Motahari hospital
Full name of responsible person
Ayub Qezelsoflu
Street address
East Taleqani St.
City
Gonbad Qabus
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Dr.Zahra Kiasalar(Vice President of Research)
Street address
First of Tehran_Qom free way, in front of Imam Khomeini(ra)'s holy shrine, Shahed University
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Faculty of Nursing and Midwifery Shahed University
Full name of responsible person
Zeinab Shaki(student)
Street address
No. 6, Shahid Rahimzade Alley, Taleghani intersection valiasr (as), Faculty of Nursing and Midwifery Shahed University
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Nursing and Midwifery Shahed University
Proportion provided by this source
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
Faculty of Nursing and Midwifery Shahed University
Full name of responsible person
Zeinab Shaki
Position
Critical Care Nursing Ms.c
Other areas of specialty/work
Street address
No. 6, Shahid Rahimzade Alley, Taleghani intersection valiasr (as), Faculty of Nursing and Midwifery Shahed University
City
Tehran
Postal code
Phone
+98 21 6641 8590
Fax
Email
Z.shaki@shahed.ac.irfshaki79@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery Shahed University
Full name of responsible person
Dr.Mohammad Reza Heidary
Position
Nursing Ph.D
Other areas of specialty/work
Street address
No. 6, Shahid Rahimzade Alley, Taleghani intersection valiasr (as), Faculty of Nursing and Midwifery Shahed University
City
Tehran
Postal code
Phone
+98 21 6641 8587
Fax
Email
heidari43@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery Shahed University
Full name of responsible person
Zeinab Shaki
Position
Critical Care Nursing Ms.c
Other areas of specialty/work
Street address
No. 6, Shahid Rahimzade Alley, Taleghani intersection valiasr (as), Faculty of Nursing and Midwifery Shahed University
City
Tehran
Postal code
Phone
+98 21 6641 8587
Fax
Email
Z.shaki@shahed.ac.irfshaki79@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)