Determining the effect of hydroalcoholic extract of Portulaca oleracea plant on antioxidant and biochemical markers of chronic hemodialysis patients in Yasouj hospitals in 1402
Design
Patients are divided into two groups A and B. 3 by 3 randomly, while the researcher is not aware of the nature of the placebo drug and the real drug, they are given placebo drug and purslane extract, which is in the form of capsules, one capsule daily for four weeks.
Settings and conduct
Chronic hemodialysis patients referred to Shahid Beheshti Yasouj Hospital are randomly divided into two groups with a ratio of 1.1. The weight and height of the patients were taken by a nurse who is blind to the groups, and one group was given a placebo (flour capsule) and one group was given 500 mg of purslane hydroalcoholic extract daily for 4 weeks.
Participants/Inclusion and exclusion criteria
1- Age above 18 years
2- Receiving hemodialysis at least twice a week for 3 months
3- Negative history of taking anti-inflammatory drugs such as corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDs) in the last month
4- Absence of active, malignant infectious diseases, rheumatic diseases and other obvious inflammatory diseases
5- Patients without history of kidney transplant and peritoneal dialysis
Intervention groups
Chronic hemodialysis patients referred to Shahid Beheshti Yasouj Hospital are randomly divided into two groups with a ratio of 1.1. The weight and height of the patients were taken by a nurse who is blind to the groups, and one group was given a placebo (flour capsule) and one group was given 500 mg of purslane hydroalcoholic extract daily for 4 weeks.
Main outcome variables
Protein carbonyl
LDL
HDL
Bun
cholesterol
Albumin
Calcium
phosphorus
triglyceride
Glutathione peroxidase
Superoxide dismutase
hs-CRP
potassium
FRAP
P-SH
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150622022869N12
Registration date:2024-04-19, 1403/01/31
Registration timing:retrospective
Last update:2024-04-19, 1403/01/31
Update count:0
Registration date
2024-04-19, 1403/01/31
Registrant information
Name
Moslem Sedaghattalab
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 0163
Email address
m.sedaghattalab@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-21, 1402/12/02
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hydroalcoholic extract of purslane plant on the level of biochemical and antioxidant factors in hemodialysis patients
Public title
The effect of purslane plant extract on the level of biochemical and antioxidant factors in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years
Receive hemodialysis at least twice a week, for 3 months
Exclusion criteria:
Positive history of taking anti-inflammatory drugs such as corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDs) in the last month
Presence of active, malignant infectious diseases, rheumatic diseases and other obvious inflammatory diseases
Patients with a history of kidney transplant and peritoneal dialysis
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
2
4 cc of the patient's serum at the beginning and end of the study
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are divided into two groups and the patients are divided into three groups. In this way, the first three patients who refer to the dialysis department for sampling are given drug A, and the other three patients are given drug B, regardless of age, sex, and underlying disease. The next three patients will receive drug A and the next three patients will receive drug B, and in the same way, patients will receive drugs randomly.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding is done in such a way that the drugs are divided into two groups, A and B, in zipped plastic bags of 28 capsules with A or B adhesive. The capsules are the same size and color, and the patient who receives the medicine and the nurse who distributes the medicine are not aware of what A and B mean.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yasuj University of Medical Science
Street address
Postal code 75917-41417, Yasuj University of Medical Science, Motahari street, Yasuj city
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75917-41417
Approval date
2023-02-15, 1401/11/26
Ethics committee reference number
IR.YUMS.REC.1401.171
Health conditions studied
1
Description of health condition studied
Unspecified kidney failure
ICD-10 code
N19
ICD-10 code description
Unspecified kidney failure
Primary outcomes
1
Description
Protein carbonyl
Timepoint
At the beginning and after 4 weeks
Method of measurement
Oxidized proteins are measured using interactions between carbonylsand 2, 4-dinitrophenylhydrazine to produce a yellow absorption dyeMax at 370 nm. PC level is determined by molar absorption.
2
Description
LDL
Timepoint
At the beginning and after 4 weeks
Method of measurement
It is measured with an autoanalyzer.
3
Description
HDL
Timepoint
At the beginning and after 4 weeks
Method of measurement
It is measured with an autoanalyzer.
4
Description
Bun
Timepoint
At the beginning and after 4 weeks
Method of measurement
It is measured with an autoanalyzer.
5
Description
cholesterol
Timepoint
At the beginning and after 4 weeks
Method of measurement
It is measured with an autoanalyzer.
6
Description
albomin
Timepoint
At the beginning and after 4 weeks
Method of measurement
It is measured with an autoanalyzer.
7
Description
calcium
Timepoint
At the beginning and after 4 weeks
Method of measurement
Measurement with a measuring kit
8
Description
phosphor
Timepoint
At the beginning and after 4 weeks
Method of measurement
Measurement with a measuring kit
9
Description
Triglycerides
Timepoint
At the beginning and after 4 weeks
Method of measurement
is measured with an autoanalyzer.
10
Description
Glutathione peroxidase
Timepoint
At the beginning and after 4 weeks
Method of measurement
It is measured by colorimetric method
11
Description
Superoxide dismutase
Timepoint
At the beginning and after 4 weeks
Method of measurement
It is measured using an ELISA kit
12
Description
hs-CRP
Timepoint
At the beginning and after 4 weeks
Method of measurement
Measurement based on latex agglutination
13
Description
potassium
Timepoint
At the beginning and after 4 weeks
Method of measurement
Measure with a measuring kit
14
Description
FRAP
Timepoint
At the beginning and after 4 weeks
Method of measurement
The scale of plasma antioxidant capacity in reducing iron ion (Feþ3) is measured based on Benzie and Strain. The blue Fe-TPTZ (Tripyridyl-s-triazine) complex is formed by the reduction of Feþ3 to ferrous ions (Feþ2) at acidic pH. Color intensity is measured by a spectrophotometer at a wavelength of 593 nm.
15
Description
Sulfhydryl protein(P-SH)
Timepoint
At the beginning and after 4 weeks
Method of measurement
measured by the colorimetric method
Secondary outcomes
empty
Intervention groups
1
Description
Patients are divided into intervention and control groups. At first, before dialysis, a venous sample is taken from the intervention group (which includes half of the dialysis patients), then purslane plant extract, which is prepared in the form of 500 mg capsules, one capsule per day for 28 days (4 weeks ) is given and at the end of the intervention, a sample is taken from them again.
Category
Treatment - Drugs
2
Description
Control group: The control group, which consists of half of the patients, is given a capsule containing starch flour every day for 4 weeks. At the beginning and end of the study, samples are taken from them.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Beheshti Hospital of Yasuj
Full name of responsible person
Moslem Sedaghattalalb
Street address
Taleghani blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591671538
Phone
+98 74 3332 4721
Email
m.sedaghattalab@gmail.com
2
Recruitment center
Name of recruitment center
Shahid Jalil Hospital in Yasuj
Full name of responsible person
Moslem Sedaghattalab
Street address
Shahid Qarni Boulevard
City
Yusuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591874934
Phone
+98 74 3333 7230
Email
pr@yu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Sayed Amin Hosaini Motlagh
Street address
Postal code 75917-41417, Yasuj University of Medical Sciences, Motahari street, Yasuj city
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75917-41417
Phone
+98 74 3334 6078
Fax
+98 74 3334 6079
Email
oryad.hossein@yums.ac.ir
Web page address
https://research.yums.ac.ir/index.aspx
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yasouj University of Medical Sciences - University Research Vice-Chancellor
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Moslem Sedaghattalab
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Street address
Postal code 75917-41417, Yasuj University of Medical Sciences, Motahari street, Yasuj city
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591647743
Phone
+98 74 3322 0163
Fax
+98 74 3322 0163
Email
m.sedaghattalab@yums.ac.ir
Web page address
https://www.yums.ac.ir/index.aspx
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Moslem Sedaghattalab
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Postal code 75917-41417, Yasuj University of Medical Sciences, Motahari street, Yasuj city
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591647743
Phone
+98 74 3322 0163
Fax
+98 74 3322 0163
Email
m.sedaghattalab@yums.ac.ir
Web page address
https://www.yums.ac.ir/index.aspx
Person responsible for updating data
Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Moslem Sedaghattalab
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Postal code 75917-41417, Yasuj University of Medical Sciences, Motahari street, Yasuj city
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591647743
Phone
+98 74 3322 0163
Fax
+98 74 3322 0163
Email
m.sedaghattalab@yums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available