Protocol summary
-
Study aim
-
The effectiveness of compounds derived from organosulfur in the treatment of children with pneumonia hospitalized in Akbar Mashhad Hospital
-
Design
-
A clinical trial with the control group, with parallel groups, three-blind, randomized, stratified, phase 3 on 70 intervention patients and 70 control patients, for randomization using www.randomization.com
-
Settings and conduct
-
Children with pneumonia symptoms are admitted to Akbar Mashhad Hospital (lung, infectious, and PICU).
Patients are randomly divided into intervention and control groups. Blinding is done in clinical assessors, data analyzers, and data collectors.
-
Participants/Inclusion and exclusion criteria
-
Criteria for entering :
• Patients aged 3 to 16 years
• The patient does not need a ventilator
• A patient with pneumonia
Criteria for not entering :
- History of allergy to allicin-L-cysteine
- History of allergy to garlic and onion
-History of hypotension or gastrointestinal bleeding
- Low blood pressure of the patient at the beginning of the study (below 120/80)
- Patients with immune deficiency
- The patient's inability to swallow oral medication that has not been inserted into an NG tube or other delivery method for any reason.
-
Intervention groups
-
intervention group:
In the intervention group, for children aged 3 to 7 years, Nicovid capsules derived from organosulfur containing 0.25 mg of the active ingredient were given every 12 hours for 7 days, and for children over 7 years of age, capsules containing 0.25 mg of the active ingredient were given every 8 hours. Once for 7 days
Control group (placebo):
In the control group, placebo administration (capsules similar to the capsules of the intervention group with neutral execution and maltodextrin combination) for 7 days
-
Main outcome variables
-
SpO2 ، CRP ، LDH ، D-dimer ، Ferritin ,CBC, ESR
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20221129056657N2
Registration date:
2023-01-25, 1401/11/05
Registration timing:
registered_while_recruiting
Last update:
2023-03-05, 1401/12/14
Update count:
1
-
Registration date
-
2023-01-25, 1401/11/05
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2023-01-20, 1401/10/30
-
Expected recruitment end date
-
2023-11-21, 1402/08/30
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
The effectiveness of oral compounds derived from Organosulfur as the treatment in pediatrics with pneumonia.
-
Public title
-
Investigating the effect of organosulfur compounds on children's lung infections
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Patient age 3 to 16 years
The patient does not need a ventilator
A patient with pneumonia and hospitalized in the special care, infectious and lung department
Exclusion criteria:
History of allergy to allicin-L-cysteine
History of allergy to garlic and onion
Patients with a history of hypotension or gastrointestinal bleeding
Low blood pressure of the patient at the beginning of the study (below 120/80)
Immune compromised patients - under chemotherapy, organ and bone marrow transplantation, and patients with autoimmune diseases
The patient's inability to swallow oral medication that is not embedded in the NGtube or other delivery method.
-
Age
-
From 3 years old to 16 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
- Care provider
- Outcome assessor
- Data analyser
-
Sample size
-
Target sample size:
70
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Individual simple randomization
Random number table randomization tool using www.randomization.com
Allocation Concealment method: envelopes
closed
In this method, first, a random sequence is created, then based on the size of the research sample, a number of envelopes with aluminum wrappers (in order to avoid the clarity of the contents of the envelopes), are prepared and each of the generated random sequences is recorded on a card, and the cards are inside The letter envelopes are placed in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of starting the registration of participants, based on the order in which eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.
-
Blinding (investigator's opinion)
-
Triple blinded
-
Blinding description
-
For blinding, ICU nurses, ICU doctors, patient treatment physicians, laboratory experts, radiology experts, statistical consultants, and data analysts were unaware of the patient's randomization and placement in the therapy group.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2022-11-22, 1401/09/01
-
Ethics committee reference number
-
IR.MUMS.MEDICAL.REC.1401.524
Health conditions studied
1
-
Description of health condition studied
-
Pneumonia
-
ICD-10 code
-
J18.0
-
ICD-10 code description
-
Bronchopneumonia, unspecified organism
Primary outcomes
1
-
Description
-
Fever
-
Timepoint
-
The first day of the study before the start of the intervention and the seventh day of the study (the last day of the intervention)
-
Method of measurement
-
Digital thermometer
2
-
Description
-
blood oxygen (SpO2)
-
Timepoint
-
The first day of the study before the start of the intervention and the seventh day of the study (the last day of the intervention)
-
Method of measurement
-
Pulse Oximeter
3
-
Description
-
Erythrocyte Sedimentation Rate (ESR)
-
Timepoint
-
The first day of the study before the start of the intervention and the seventh day of the study (the last day of the intervention)
-
Method of measurement
-
Westergren method
Secondary outcomes
1
-
Description
-
blood pressure
-
Timepoint
-
At the beginning of the study (before the start of the intervention) and on the seventh day after the start of the intervention
-
Method of measurement
-
Mercury sphygmomanometer
2
-
Description
-
heart beat
-
Timepoint
-
At the beginning of the study (before the start of the intervention) and on the seventh day after the start of the intervention
-
Method of measurement
-
Pulse oximeter
3
-
Description
-
Blood gases
-
Timepoint
-
At the beginning of the study (before the start of the intervention) and on the seventh day after the start of the intervention.
-
Method of measurement
-
Blood gas measuring device
4
-
Description
-
C reactive protein
-
Timepoint
-
At the beginning of the study (before the start of the intervention) and on the seventh day after the start of the intervention.
-
Method of measurement
-
Taking blood samples and laboratory kits
5
-
Description
-
Lactate dehydrogenase
-
Timepoint
-
At the beginning of the study (before the start of the intervention) and on the seventh day after the start of the intervention.
-
Method of measurement
-
Electrophoresis method
6
-
Description
-
D-dimer
-
Timepoint
-
At the beginning of the study (before the start of the intervention) and on the seventh day after the start of the intervention.
-
Method of measurement
-
Using Vidas laboratory kit
7
-
Description
-
complete blood count(CBC)
-
Timepoint
-
At the beginning of the study (before the start of the intervention) and on the seventh day after the start of the intervention.
-
Method of measurement
-
Blood cell counting machine
8
-
Description
-
Ferritin
-
Timepoint
-
At the beginning of the study (before the start of the intervention) and on the seventh day after the start of the intervention.
-
Method of measurement
-
Use of ELISA laboratory kit(Enzyme-linked immuno_sorbent assay)
Intervention groups
1
-
Description
-
Intervention group: Capsules derived from organosulfur (Nicovid capsules are ordered by Surin Salamat Sabz Tehran Company and produced by Esveh Pharmaceutical Company. Each capsule contains standardized organosulfur of garlic extract based on: Allicin, L-Cysteine, L-Methionine, Maltodextrin, and Vanilla.), containing 0.25 mg of the active ingredient, for children three to seven years old every 12 hours for 7 days and for children over 7 years old every 8 hours Duration of 7 days.
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: Administration of placebo (capsules similar to those of the intervention group with neutral implementation and maltodextrin combination) for children three to seven years old every 12 hours for 7 days and for children over 7 years old every 8 hours for 7 days.
-
Category
-
Placebo
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
No
-
Title of funding source
-
Hossein Niktale
-
Proportion provided by this source
-
100
-
Public or private sector
-
Private
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Industry
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
-
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
-
No - There is not a plan to make this available
-
Data Dictionary
-
No - There is not a plan to make this available
-
Title and more details about the data/document
-
Part of the data related to the main outcomes
-
When the data will become available and for how long
-
Six months after the results are published
-
To whom data/document is available
-
Academic institutions
-
Under which criteria data/document could be used
-
For the purpose of research for the academic community
-
From where data/document is obtainable
-
Dr. Gholamreza Khademigh Khademigh@mums.ac.ir
-
What processes are involved for a request to access data/document
-
The request will be sent by email to Dr. Gholamreza Khademi after correspondence about two weeks after the registration of the data request.
-
Comments
-