Determination of the Effect of Hydroalcoholic Extract of Nasturtium officinale on Anti-oxidant Markers and Biochemical Markers in Patients Under Chronic Hemodialysis
This randomized trial is done in dialysis department of Yasuj Shahid Beheshti Hospital. Patients and clinical caregivers and clinical evaluators are blinded to how the drug is allocated.
Participants/Inclusion and exclusion criteria
1) aged over 18 years
2) Receive hemodialysis at least twice a week, for about 3 months
3) Negative history of using medications with known effect on inflammatory markers such as corticosteroids and nonsteroidal anti-inflammatory drugs (NSAIDs) in the last month;
(4) No active infectious diseases, malignant, rheumatic diseases and other inflammatory diseases
Intervention groups
Patients are divided into 1 to 1 case and control groups (placebo) for 4 weeks.
Main outcome variables
Anti-oxidant Markers, Biochemical Markers
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150622022869N7
Registration date:2019-08-04, 1398/05/13
Registration timing:retrospective
Last update:2019-08-04, 1398/05/13
Update count:0
Registration date
2019-08-04, 1398/05/13
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
2019-06-25, 1398/04/04
Expected recruitment end date
2019-07-26, 1398/05/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hydroalcoholic extracts of Nasturtium officinale on antioxidant markers in chronic hemodialysis patients
Public title
The effect of hydroalcoholic extracts of Nasturtium officinale on antioxidant markers in chronic hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged over 18 years;
Receive hemodialysis at least twice a week, for about 3 months;
Negative history of using medications with known effect on inflammatory markers such as corticosteroids and nonsteroidal anti-inflammatory drugs (NSAIDs) in the last month;
No active infectious diseases, malignant, rheumatic diseases and other inflammatory diseases.
Exclusion criteria:
Patients who require additional supplementary therapies (taking medications that affect the inflammatory process during the study)
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted Blocks was used for randomization with blocks of the size of 4 that after every 4 patients there was an equal number assigned to each treatment. For each block, one of the arrangements (CCII, CICI, ICCI, IICC, ICIC, CIIC) was randomly chosen(C= Control, I= Intervention). Clinical caregivers and patients are unaware of how to divide and type of drug.
Blinding (investigator's opinion)
Double blinded
Blinding description
Clinical caregiver and the assessor of the outcome are not aware of groups.
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 Sciences
Street address
keshavarzi blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2019-06-24, 1398/04/03
Ethics committee reference number
IR.YUMS.REC.1398.037
Health conditions studied
1
Description of health condition studied
Patients with end stage kidney disease under hemodialysis
ICD-10 code
N18.6
ICD-10 code description
End stage renal disease
Primary outcomes
1
Description
Bun, cholesterol, Low Density Lipoproteinn, High Density lipoProtein, triglyceride, potassium, albumin, calcium and phosphorus and antioxidant tests including malondialdehyde, glutathione peroxidase, superoxide dismutase, high sensitive-CRP, Total Oxidant capacity, Total Antioxidant capacity, P-SH
Timepoint
At the beginning of the study and 28 days later
Method of measurement
Antioxidant and biochemical tests
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: group receiving the drug, which contains 500 mg of Hydroalcoholic extract of the grass spring daily on dialysis days after dialysis. In order to reduce possible gastrointestinal symptoms, it is advisable to take the medicine with food.
Category
Treatment - Drugs
2
Description
Control group: includes a 500 mg capsule containing flour with a container that is similar to the drug group in appearance (capsule color, glass size and glass content of the capsule), and the same recommendations are given to the patients.
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
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hossein Marie Oriad
Street address
Keshavarzi blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3332 6078
Fax
+98 74 3334 6079
Email
m.sedaghattalab@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj University of Medical Sciences
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
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
60 Metri blvd, Golestan10 street
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Email
m.sedaghattalab@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Moslem sedaghat talab
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
60 Metri blvd, Golestan 10 street
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Email
m.sedaghattalab@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Moslem sedaghat talab
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
60 Metri blvd, Golestan 10 street
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Email
m.sedaghattalab@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
No - There is not 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
Yes - There is 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
Title and more details about the data/document
No more information
When the data will become available and for how long
No more information
To whom data/document is available
No more information
Under which criteria data/document could be used
No more information
From where data/document is obtainable
No more information
What processes are involved for a request to access data/document