Investigating the effects of oral medium-chain triglyceride (MCT) on the process of disease symptoms in patients with viral respiratory tract infection in outpatients with metabolic syndrome
Determining the effect of moderate oral triglyceride administration on the course of symptoms in outpatients with viral respiratory tract infection with metabolic syndrome
Design
Clinical trial with control group, with parallel groups, without blinding, randomized, phase 3 on 80 patients. Random Allocation Software was used for randomization.
Settings and conduct
First, patients referred to viral respiratory tract infection and metabolic syndrome are identified to Afzalipour Medical Center within a 6 months. Then they enter the study based on entry and exit criteria and based on random sampling and after obtaining informed consent. At this stage, their demographic information will be recorded and the drug will be studied and the relevant training will be provided to them. Body temperature, number of breaths per minute, rate of body pain, cough and side effects using a questionnaire that the patient must fill in on days zero (referral time) 1, 2, 3, 4, 7, 14 to both groups of intervention and Controls are evaluated.
Participants/Inclusion and exclusion criteria
Admission Requirements: Metabolic Syndrome as defined by the International Diabetes Federation (IDF)
Non-entry conditions: Allergy to the drug
Pregnancy / breastfeeding
Asthma and allergies
Congestive heart failure
Chronic renal failure
Malignancy
Immune system defects
Intervention groups
Intervention group: Administration of oral medium-chain triglyceride at a dose of 2 tablespoons after each meal and daily recording of symptoms
Control group: daily recording of symptoms
Main outcome variables
Cough intensity; Number of coughs; Breathing speed; body pain; Fever; death; Hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201019049079N1
Registration date:2021-07-03, 1400/04/12
Registration timing:registered_while_recruiting
Last update:2021-07-03, 1400/04/12
Update count:0
Registration date
2021-07-03, 1400/04/12
Registrant information
Name
Mohammad Amin Fallah Mehrizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3325 7660
Email address
amin.fallah44@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-05, 1400/03/15
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of oral medium-chain triglyceride (MCT) on the process of disease symptoms in patients with viral respiratory tract infection in outpatients with metabolic syndrome
Public title
MCT Oil in viral respiratory tract infection in patient with metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Metabolic Syndrome as defined by the International Diabetes Federation (IDF): Abdominal obesity above 94 cm in men and 80 cm in women plus two of the following criteria: IFG above 100, triglyceride above 150, HDL below 40 in men and below 50 in women And have systolic blood pressure above 130 mmHg or diastole above 85 mmHg
Symptoms of viral respiratory tract infection
Exclusion criteria:
Drug allergy
Pregnancy / breastfeeding
Asthma and allergies
CHF
CRF
malignancy
Immune system defects such as AIDS and corticosteroids
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Using Random Allocation Software, patients are randomly divided into intervention and control groups.
The samples will be determined by random blocking method with 4 blocks and using the table of random numbers of Software Allocation Random software. Blocking and allocation sequencing for concealment will be done by the person not involved in the research (Allocation
Concealment. The sample allocation ratio will be 1: 1 Allocation and will be placed in two groups receiving Iranian medicine products and control (Assignment. Will be given
The study is Lable-Open and blinding will not happen.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Afzalipoor Hospital of Kerman Medical University
Street address
pajoohesh square
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2021-05-31, 1400/03/10
Ethics committee reference number
IR.KMU.AH.REC.1400.047
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
B97.29
ICD-10 code description
Other coronavirus as the cause of diseases classified elsewhere
2
Description of health condition studied
Seasonal Influenza
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Adult Cold
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Symptoms of viral respiratory tract infection (fever, cough, body aches, shortness of breath)
Timepoint
Days 0 (visit day) ,1,2,3,4,7 and 14
Method of measurement
Questionnaire and question from the patient
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: To determine the effect of the substance mentioned in the text of Take 2 tablespoons of Medium-Chain Triglyceride oil after each meal for 7 days, and after this Action The healing process was examined chemical formula: Triglyceride with two or three fatty acids having an aliphatic tail of 6–12 carbon atoms. This drug is not produced in the country.
Category
Treatment - Drugs
2
Description
Control group: No special intervention is performed. (Except filling out the questionnaire)
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipoor haspital
Full name of responsible person
Hamid Abosaidi
Street address
Pajoohesh Square
City
Kerman
Province
Kerman
Postal code
98 34 3121 5600
Phone
+98 34 3121 5600
Email
amin.fallah44@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Somayeh Crossroads (Tahmasb Abad) at the beginning of Ibn Sina Street, Deputy of Research and Technology
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
vcr@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Mohammad Amin Fallah Mehrizi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Afzalipoor Hospital
City
Kerman
Province
Kerman
Postal code
7617735967
Phone
+98 34 3325 7660
Fax
Email
amin.fallah44@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Masoud Moghadari
Position
Deputy Director of Management and Resources Development
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7617735967
Phone
+98 34 3132 5820
Email
masoudmoghaderi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohammad Amin Fallah Mehrizi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Afzalipoor Hospital
City
Kerman
Province
Kerman
Postal code
7617735967
Phone
+98 34 3325 7660
Fax
Email
amin.fallah44@gmail.com
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
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
Title and more details about the data/document
Measured variables are available after unidentifiable individuals.
When the data will become available and for how long
Up to one year after publish results.
To whom data/document is available
All people in the research centers.
Under which criteria data/document could be used
Allowed for any use.
From where data/document is obtainable
Mohammad Amin Fallah, 09135258850, amin.fallah44@gmail.com
What processes are involved for a request to access data/document
After contacting and knowing the identity of the person, information will be provided to them.