The aim is Investigating the effect of curcumin consumption on liver enzyme levels in opium-poisoned patients hospitalized in the Poisoned ICU department of Loghman Hakim Hospital 2022-2023.
Design
This clinical trial study has two intervention and control groups, double-blind, randomized, with parallel groups, on 30 opium-poisoned patients. Block method will be used for randomization.
Settings and conduct
This clinical trial study has two intervention groups, double-blind, randomized, on 30 opium-poisoned patients and admitted to the intensive care unit at Luqman Hakim Hospital. The patients will be people referred to Luqman Hakim Hospital with opium poisoning in 2022, who have consented to participate and have no other poisoning. Block method will be used for randomization, also in blinding, clinical care and patient companion will be blind. 15 of them are subjected to curcumin gavage and the other 15 are subjected to normal saline gavage.
Participants/Inclusion and exclusion criteria
Patients with opium poisoning, referring to the emergency department of Loghman Hospital in Tehran, who were admitted to the intensive care unit, were included in the study, and patients with simultaneous poisoning with other drugs, the lack of consent of companions to participate in the study and dead cases were excluded from the study.
Intervention groups
Patients in the intervention group will be subjected to curcumin supplemental gavage with a dose of 1500 mg daily for 7 days, manufactured by Dineh Pharmaceutical Company, and in the control group normal saline gavage will be used.
Main outcome variables
Liver enzyme levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220305054196N2
Registration date:2023-04-09, 1402/01/20
Registration timing:registered_while_recruiting
Last update:2023-04-09, 1402/01/20
Update count:0
Registration date
2023-04-09, 1402/01/20
Registrant information
Name
Mitra Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 4041
Email address
mrahimi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-20, 1401/12/29
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of curcumin consumption on liver enzyme levels in opium-poisoned patients hospitalized in the Poisoned ICU department
Public title
Investigating the effect of curcumin on the levels of liver enzymes in opium poisoning
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Opium poisoning
Referred to the emergency department of Loghman Hospital in Tehran
admitted to the intensive care unit
Exclusion criteria:
Concomitant poisoning with other drugs
Lack of consent of companions to participate in the study
death of the patient
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the restricted randomization method of the block randomization type. The size of all the blocks is equal and we will have 6 blocks in this two-group trial, and considering 5 blocks, a total of 30 patients will be evaluated. The randomization tool will be random allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
After the selection of the samples, none of the sampled people will know about the randomization and the process of allocation to the groups, medicine and placebo are completely similar, on this basis and with the patients' lack of information about the group they are in, they have been blinded. Doctors are given a table of coded numbers in advance and patients are entered into the study in the order of the numbers in the table. Therefore, the present study is double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Poisoned Complex, Loghman Hakim Hospital, South Kargar St, Tehran
City
Tehran
Province
Tehran
Postal code
1333635445
Approval date
2023-03-12, 1401/12/21
Ethics committee reference number
IR.SBMU.SME.REC.1401.095
Health conditions studied
1
Description of health condition studied
Poisoning by opium
ICD-10 code
T40.0X4
ICD-10 code description
Poisoning by opium, undetermined
Primary outcomes
1
Description
Liver enzyme levels
Timepoint
Before treatment and daily up to 7 days after treatment
Method of measurement
Blood sampling is done and the level of liver enzymes is determined using a laboratory kit.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Curcumin supplement gavage, dose 1500 mg daily for 7 days, Dineh Pharmaceutical Company
Category
Treatment - Drugs
2
Description
Control group: Normal saline gavage, with the rate of 1500 mg daily for 7 days, Dina Pharmaceutical Company.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Mitra Rahimi
Street address
Poisoned Complex, Loghman Hakim Hospital, South Kargar St, Tehran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
loghman.hospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hale Talaie
Street address
Toxicological Research Center, Loghman Hakim Hospital, Kamali Ave, South Kargar St, Tehran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 8175
Email
trc.info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mitra Rahimi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Toxicology
Street address
Poisoned Complex, Loghman Hakim Hospital, South Kargar St, Tehran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
mrahimi744@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mitra Rahimi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Toxicology
Street address
Poisoned Complex, Loghman Hakim Hospital, South Kargar St, Tehran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
mrahimi744@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mitra Rahimi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Toxicology
Street address
Poisoned Complex, Loghman Hakim Hospital, South Kargar St, Tehran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
mrahimi744@gmail.com
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
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