Evaluating the effectiveness of Silymarin on the prevention of gentamicin nephrotoxicity in hospitalized patients at Imam Reza & Vali-Asr hospitals in Birjand
Determine the efficiency of silymarin in the prevention of gentamicin-induced nephrotoxicity in patients hospitalized in Imam Reza and Vali-Asr hosptals in Mashhad, Iran
Design
A clinical trial was conducted in two groups of control and treatment groups, double blind, randomized with permutable blocking method
Settings and conduct
Multi-center, randomized, double-blind, placebo-controlled clinical trials in two educational centers affiliated to Birjand University of Medical Sciences including Imam Reza Hospital and Vali-e-Asr Hospitals
Participants/Inclusion and exclusion criteria
Patients referring to educational hospitals of Birjand University of Medical Sciences who have been diagnosed with systemic gentamicin for at least 7 days with the following conditions: The patient's hemodynamic stability; the desire to participate in the study; gentamicin is given intravenously or intramuscularly for at least 1 week; no history of confirmed acute kidney injury; no history of confirmed chronic kidney injury; no use of gentamicin by intravenous or muscle in the past 14 days; no history of confirmed allergic reactions following oral administration of silymarin; no history of confirmed allergic reactions following oral administration of silymarin; do not receive medications or antioxidant compounds; do not receive high-renal toxicity medicines at the same time; oral tolerance to medications.
Intervention groups
Two treatment groups and control.
Gentamycin will be injected to patients in both groups based on the treatment protocol. However, in the patients in the treatment group, the Silymarin tablet of goldaru company (livergol) (140 mg three times daily) is prescribed orally and as long as the gentamicin is prescribed.
Main outcome variables
Determine the efficacy of silymarin in preventionof increase in serum gentamicin-induced creatinine levels, GFR reduction, ATN, and electrolyte imbalance caused by gentamicin
General information
Reason for update
Acronym
SNG
IRCT registration information
IRCT registration number:IRCT20161010030246N3
Registration date:2018-11-21, 1397/08/30
Registration timing:registered_while_recruiting
Last update:2018-11-21, 1397/08/30
Update count:0
Registration date
2018-11-21, 1397/08/30
Registrant information
Name
Iman Karimzadeh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3242 4128
Email address
karimzadee@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of Silymarin on the prevention of gentamicin nephrotoxicity in hospitalized patients at Imam Reza & Vali-Asr hospitals in Birjand
Public title
Evaluating the effectiveness of Silymarin on the prevention of gentamicin nephrotoxicity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The patient's hemodynamic stability
The desire to participate in the study
Gentamicin is given intravenous or intramuscular for at least 1 week at a dose of 5 mg / kg / day or 80-100 mg / TDS
No history of confirmed acute kidney injury.
No history of confirmed chronic kidney injury.
No use of gentamicin by intravenous or muscle in the past 14 days.
No history of confirmed allergic reactions following oral administration of silymarin
No history of confirmed allergic reactions following oral administration of silymarin
Do not receive medications or antioxidant compounds such as vitamin C, vitamin E or vitamin A
Do not receive high-renal toxicity medicines at the same time
Oral tolerance to medications
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
6
Sampling of urine and blood (5 ml) of patients will be give before starting the drug (day zero) and on days 1, 2, 3, 5 and 7, gentamicin treatment .
Randomization (investigator's opinion)
Randomized
Randomization description
Multi-center, random blocking permutations, double-blind, placebo-controlled clinical trials
Blinding (investigator's opinion)
Double blinded
Blinding description
Researcher does not know the drug that the patient gives,is a placebo or the main drug.
On the other hand, the participant (the patient) is not aware of the fact that the drug given to him is the main drug or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71345-1978
Approval date
2018-07-04, 1397/04/13
Ethics committee reference number
IR.SUMS.REC.1397.330
Health conditions studied
1
Description of health condition studied
Gentamicin-induced renal toxicity in hospitalized patients
ICD-10 code
A30-A49
ICD-10 code description
Other bacterial diseases
Primary outcomes
1
Description
Determination of the efficacy of silymarin in preventing renal toxicity due to gentamicin by measuring the malondialdehyde indicator, evaluation of thiol groups, isoprostane and deoxy guanosine, serum creatinine level, serum urea nitrogen, sodium, potassium and magnesium concentration, and calculating sodium, potassium, Magnesium and urea
Timepoint
Sampling from urine and blood (5 ml) of patients before starting the drug (day zero) and on days 1, 2, 3, 5 and 7, treatment with gentamicin
Method of measurement
Measurement of serum and urine levels of electrolytes, urea and creatinine using an autoanalyzer and Isoprostane and desoxy Guanosine indicator will be performed using ELISA and Zell bio kit.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, as long as the gentamicin is prescribed, the tablet of silymarin is prescribed by the Goldaru company (Livergol) at an oral dose of 140 mg three times daily.
Category
Prevention
2
Description
Control group: in this group patients with gentamicin will receive placebo 140 mg three times a day orally.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza & Vali-Asr hospitals in Birjand
Full name of responsible person
Iman Karimzadeh
Street address
Roknabad, Shiraz 5Km, Karafarin St., Faculty of Pharmacy
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 3242 4127
Fax
+98 71 3242 4126
Email
karimzadee@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Basir Hashemi
Street address
Shiraz University of Medical Sciences, Next to red Crescent, Zand street, Shiraz
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Email
hashemib@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Iman Karimzadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Shiraz-Roknabad-Karafarin street-Faculty of Pharmacy
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 3242 4128
Fax
+98 71 3242 4126
Email
karimzadee@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Iman karimzadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Department of clinical pharmacy,Namazi hospital,Namazi Squre
City
Shiraz
Province
Fars
Postal code
11351 – 71937
Phone
+98 71 3647 4332
Fax
+98 71 3647 4326
Email
karimzadee@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Motahare Mahi Birjand
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Zand Avenue,Namazi Square, Namazi hospital,Shiraz
City
Shiraz
Province
Fars
Postal code
71937-11351
Phone
+98 71 3647 4332
Fax
+98 71 3647 4326
Email
mahibirjand@sums.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
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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