Objectives: Evaluation of the anti-inflammatory effects of Cannabis sativa seed oil in hemodialysis patients
Design: This study is a randomized single blind (researchers who measure the serum concentration of interleukins and analyze the results do not have any information about the assignment of patients to each group) clinical trial. One hundred thirty hemodialysis patients from 2 dialysis centers will be entered to the study. Patients will be randomly assigned to the intervention or control group based on simple block randomization.
Setting: The oil will be obtained by the cold pressing of the hemp seeds. Patients will receive 20 ml of the hemp seed oil per day in the intervention group. In the control group patients will receive no treatment.
Participants: patients who are undergoing regular hemodialysis for at least 3 months will be recruited. Patients who have an infection or who are consuming immunosuppressive medications will be excluded.
Main outcome measures: Primary outcome variables: The serum concentrations of interleukin 6 and interleukin 33. These variables will be measured by the ELISA kits.
Secondary outcome variables: Adverse effects. This variable will be recorded based on the patients’ reports.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017031522637N3
Registration date:2017-05-01, 1396/02/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-01, 1396/02/11
Registrant information
Name
Naemeh Nikvarz
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5017
Email address
nnikvarz@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Kerman University of Medical Sciences
Expected recruitment start date
2017-03-05, 1395/12/15
Expected recruitment end date
2017-09-06, 1396/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of Cannabis sativa L. seed oil on the serum concentration of interleukin 6 and interleukin 33 in hemodialysis patients
Public title
Anti inflammatory effects of Cannabis sativa L. seed oil in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients undergoing regular hemodialysis for at least 3 months
Exclusion criteria: active infection; consuming immunosuppressive medications; autoimmune diseases
Age
From 18 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences