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The effect of Omega3 on uremic pruritus and sleep quality in patients treated with hemodialysis

Protocol summary

Summary
The study was a randomized clinical trial and to cross over is executed. The aim of this study was to determine the efficacy of omega-3 and Cetirizine of uremic pruritus in hemodialysis patients is the quality of sleep. First, patients with uremic pruritus in dialysis centers affiliated to University of Medical Sciences anymore hemodialysis are identified and then put them in a random order 52 if you wish to participate in the design and inclusion criteria itching more than 8 weeks, the lack of skin irritation, lack of sensitivity to omega-3, a lack of malabsorption or gastrointestinal disease, such as chronic diarrhea more than 2 weeks and no anticoagulation or antiplatelet enrolled in the study and in the case of drug intolerance, kidney transplantation, use of antihistamines or gabapentin , anemia with hemoglobin less than 7 g per deciliter, PTH greater than 300 micrograms per listeria F INR, and prohibiting its use of antihistamines (blurred vision, glaucoma, etc.) are excluded. Group therapy (26) Omega-3 capsules, 1000 mg, 3 per day and Cetirizine 5 mg, 3 times a week and the control group (n = 26) standard treatment with Cetirizine 5 mg, 3 times a week for 6 weeks will. After a week of the lack of medicine, the two groups are reversed. And 6 weeks alternatives are used. The severity of itching and sleep quality 3 times (baseline and end of each phase of treatment is control.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017040433206N1
Registration date: 2017-05-10, 1396/02/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-05-10, 1396/02/20
Registrant information
Name
mansooreh heydarbeyki
Name of organization / entity
University of Medical Sciences anymore
Country
Iran (Islamic Republic of)
Phone
+98 32395054
Email address
m.heydarbeyki@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
. This is a master degree student's thesis are sponsored by University of Medical Sciences anymore done Summary *
Expected recruitment start date
2017-05-05, 1396/02/15
Expected recruitment end date
2017-08-04, 1396/05/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Omega3 on uremic pruritus and sleep quality in patients treated with hemodialysis
Public title
The effect of Omega3 supplementation on uremic pruritus and sleep quality
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria: 1. Age over 18 years 2. patients with chronic renal failure 3. The dialysis time per session, frequency of dialysis per week are the same in both groups. Exclusion criteria: 1. patients younger than 18 years 2. Patients who have used other anti-itch medication and treatment has been effective. 3. The patient's unwillingness to continue the research. 4-malabsorption or any digestive problems (such as chronic diarrhea more than 2 weeks). 5. skin disease that cause itching dermatologist discretion and is not related uremic pruritus. 6. contraindicated antihistamines (blurred vision, glaucoma, prostate, dementia, neurological disorders -Zlany) 7. received drugs or treatments that have the same itch topical emollients, UV rays and effective. 8Sensitivity to omega-3. 9. The patient died
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
n this study, patients are not deprived of the standard treatment of uremic pruritus. The intervention group received treatment with omega-3 Cetirizine and control group to receive treatment with Cetirizine alone.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
University of Medical Sciences anymore
Street address
haft tir squar University of Medical Sciences anymore
City
shahrood
Postal code
Approval date
2017-03-07, 1395/12/17
Ethics committee reference number
ir.shmu.rec.1395.187

Health conditions studied

1

Description of health condition studied
end stage renal desease
ICD-10 code
n18.0
ICD-10 code description
renal end stage(failer

Primary outcomes

1

Description
Uremic pruritus
Timepoint
3 times (baseline, 6 weeks after the intervention, and at the end of the study)
Method of measurement
35/5000 Did you mean: پرسشنامه خارش یوسیپوویچ Save Reset Itching questionnaire Yvsypvych

Secondary outcomes

1

Description
sleep quality
Timepoint
3 times (baseline, 6 weeks after the end of the study)
Method of measurement
Pittsburgh Sleep Questionnaire

Intervention groups

1

Description
Intervention group receive omega 3 g 3 times a day and Cetirizine 5 mg 3 times a week for 6 weeks, and control group receive standard treatment (Cetirizine 5 mg 3 times a week) for 6 weeks will receive.
Category
Treatment - Drugs

2

Description
Control group: standard treatment with Cetirizine 5 mg, 3 times a week for 6 weeks to receive.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hussein hospital anymore
Full name of responsible person
dr monireh amerian
Street address
shahrood emam street emam hosain squar
City
shahrood

2

Recruitment center
Name of recruitment center
28/5000 Red Crescent Dialysis Center anymore
Full name of responsible person
mansooreh heydarbeyki
Street address
Street 22 St. Azadegan commercial complex in its treatment of dialysis centers Razavian
City
shahrood

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technological Sciences anymore
Full name of responsible person
MH Emamian
Street address
haft tir squar
City
shahrood
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technological Sciences anymore
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
School of Nursing and Midwifery University of Medical Sciences King
Full name of responsible person
mansooreh heydarbeyki
Position
A graduate student in intensive care nurse
Other areas of specialty/work
Street address
Haft Tir Square anymore University of Medical Sciences and Health Services
City
shahrood
Postal code
36147-73947
Phone
+98 23 3239 5054
Fax
+98 32395009
Email
elmira139207@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nursing and midwifery anymore
Full name of responsible person
Doctor Hossein Ebrahimi
Position
PhD
Other areas of specialty/work
Street address
Haft Tir Square anymore University of Medical Sciences and Health Services
City
shahrood
Postal code
36147-73947
Phone
+98 23 3239 5054
Fax
+98 32395009
Email
ebrahimi@shmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nursing and midwifery anymore
Full name of responsible person
mansooreh heydarbeyki
Position
Graduate student nursing care
Other areas of specialty/work
Street address
Haft Tir Square anymore University of Medical Sciences and Health Services Anymore
City
shahrood
Postal code
36147-73947
Phone
+98 23 3239 5054
Fax
+98 32395009
Email
elmira139207@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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