To compare the effectiveness of Allicin with placebo on survival of sepsis patients in intensive care units
Design
This randomized and double-blind clinical trial with parallel and control groups will be conducted on 110 patients who will be randomly selected using the blocks.
Settings and conduct
Sepsis patients admitted to the intensive care unit to Imam Reza Hospital and Ghaem Hospital, Mashhad, Iran are chosen as the participants of the study. In this double-blind study, sealed opaque envelopes will be used to conceal the sequencing. Intervention group will receive the Allicin and control will receive placebo. The participants and person responsible for data collection are blind to group allocation and the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years; diagnosis of sepsis due to lung infection; not pregnant; not breastfeeding.
Exclusion criteria: Having Allicin allergies; having a history of hypotension; having gastrointestinal bleeding; having hypotension; taking warfarin; having immunodeficiency disorders; inability of patient to take oral medication; having hepatic failure; having renal failure; having a history of neuromuscular disorders.
Intervention groups
The intervention group will receive 90 mg capsules of Nicovid, which is derived from Organosulfur, orally every 6 hours for 7 days.
The control group will receive placebo orally every 6 hours for 7 days.
Main outcome variables
Evaluation of SpO2 level, mortality rate, number of days dependent on ventilator, dependent on vasopressor rate, serum level of acute-phase proteins and incidence of respiratory distress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220508054780N3
Registration date:2023-12-01, 1402/09/10
Registration timing:prospective
Last update:2023-12-01, 1402/09/10
Update count:0
Registration date
2023-12-01, 1402/09/10
Registrant information
Name
Benyamin Fazli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2711
Email address
fazlib@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2025-01-20, 1403/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of Allicin with placebo on survival of sepsis patients in intensive care units
Public title
The effectiveness of Allicin on survival of sepsis patients in intensive care units
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Diagnosis of sepsis due to lung infection
Not pregnant
Not breastfeeding
Exclusion criteria:
Having Allicin allergies
Having a history of hypotension
Having gastrointestinal bleeding
Having hypotension
Taking warfarin
Having immunodeficiency disorders
Inability of patient to take oral medication
Having hepatic failure
Having renal failure
Having a history of neuromuscular disorders
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be simple randomly assigned to two groups using the blocks and opaque envelopes will be used for concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants and responsible for data collection are blind to group allocation and the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2023-08-14, 1402/05/23
Ethics committee reference number
IR.MUMS.IRH.REC.1402.122
Health conditions studied
1
Description of health condition studied
Sepsis
ICD-10 code
A41.9
ICD-10 code description
Sepsis, unspecified organism
Primary outcomes
1
Description
SpO2 level
Timepoint
At the beginning of study and 7 days after intervention
Method of measurement
Pulse Oximeter
2
Description
Mortality rate
Timepoint
7 days after intervention
Method of measurement
Based on acute physiology and chronic health evaluation score (APACHE) II score
3
Description
Number of days dependent on ventilator
Timepoint
7 days after intervention
Method of measurement
The number of days the ventilator is used for the patient
Secondary outcomes
1
Description
Dependent on vasopressor rate
Timepoint
7 days after intervention
Method of measurement
The number of times the drug is prescribed to the patient
2
Description
Serum level of acute-phase proteins
Timepoint
At the beginning of study and 7 days after intervention
Method of measurement
C-Reactive Protein (CRP) test
3
Description
Incidence of respiratory distress
Timepoint
7 days after intervention
Method of measurement
Based on patient clinical trials
Intervention groups
1
Description
Intervention group: The intervention group will receive 90 mg capsules of Nicovid, which is derived from Organosulfur (Daghigh Tajhiz Ario, Tehran, Iran), orally every 6 hours for 7 days.
Category
Treatment - Drugs
2
Description
Control group: The control group will receive placebo (There is no Organosulfur in it, but it has the same color, taste, structure and shape as Nicovid, produced by the research center of faculty of pharmacy, Mashhad University of Medical Sciences) orally every 6 hours for 7 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Benyamin Fazli
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2711
Email
fazlib@mums.ac.ir
2
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Benyamin Fazli
Street address
Ghaem Hospital, Ahmadabad Street, Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3840 0000
Email
fazlib@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Benyamin Fazli
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2711
Email
fazlib@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Benyamin Fazli
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2711
Email
fazlib@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Benyamin Fazli
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2711
Email
fazlib@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The research data obtained from the main outcomes of the study can be shared freely as 'open data'.
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
The research data is exclusively accessible to the researchers working at universities and centers for scientific research.
Under which criteria data/document could be used
The research data is exclusively accessible to the researchers working at universities and centers for scientific research.
From where data/document is obtainable
Benyamin Fazli provides the data analysis to the applicants via email: fazlib@mums.ac.ir
What processes are involved for a request to access data/document
Applicants can send emails to him and receive a response within a week.