The effect of Curcuma herbal hybrid distillate on clinical course and laboratory parameters in outpatients with COVID-19: A randomized controlled trial
To determining the effect of combined curcuma herbal distillate on clinical course and laboratory parameters in outpatients with COVID-19
Design
The controlled clinical trial, with two parallel arms, triple-blind, randomized, phase 3 on 200 patients. Random Allocation Software will be used for randomization
Settings and conduct
Eligible people with coronary heart disease who will visit Asadabadi hospital in Tabriz will be selected through easy sampling. Participants will be randomly assigned to two groups of consumers of Curcuma drug and placebo using a random blocking method with a 1: 1 allocation ratio. The researcher, participant, data analyst, and outcome assessor will be blind.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:People with COVID-19 with a positive specificity test; age 18 to 65 years; Do not participate in another clinical trial at the same time
Exclusion criteria: Pregnant and lactating women; Having kidney and liver failure; Candidates admitted at the beginning of the study; Having a safety defect; Coagulation disorders and the use of anticoagulants
Intervention groups
The first group will receive 10 cc of curcuma daily every 6 hours for 10 to 14 days. The second group will receive the placebo similar to the first group with the same prescription.
Main outcome variables
Hospitalization rate after the start of the intervention; Mortality rate after the start of the intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220508054778N1
Registration date:2022-05-24, 1401/03/03
Registration timing:prospective
Last update:2022-05-24, 1401/03/03
Update count:0
Registration date
2022-05-24, 1401/03/03
Registrant information
Name
Mohammadreza Mirzaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3327 3406
Email address
dr.mirzaei_m@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-31, 1401/03/10
Expected recruitment end date
2022-08-27, 1401/06/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Curcuma herbal hybrid distillate on clinical course and laboratory parameters in outpatients with COVID-19: A randomized controlled trial
Public title
The effect of Curcuma herbal hybrid distillate on clinical course and laboratory parameters in outpatients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Affected individuals identified by a specific corona diagnosis test
Having a conscious consent form signed to participate in the study
Failure to participate simultaneously in another clinical trial
Exclusion criteria:
People with suspicious and probable symptoms of the disease
pregnant women
Breastfeeding women
Liver or kidney failure based on individual or family statements
Candidates admitted at the beginning of the study
Immune deficiency (treated with corticosteroids over 12.5 mg / d, prednisolone over two weeks, chemotherapy, malignancies, organ transplants, HIV patients, other viral diseases)
Coagulation disorders and the use of anticoagulants
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible individuals identified using RAS computer software will be divided into 2 intervention and control groups with 4 and 6 blocking and 1: 1 allocation ratio.Drugs and placebos are packaged in similar bottles in exactly the same way and will be coded from 1 to 200 based on the allocation sequence prepared by The person is blind in the research and will be provided to the participants.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The first group will consume 10 cc of Curcuma herbal extract every 6 hours and the second group will receive a placebo that will be the same in shape, color, smell, etc. For partial blinding of the subjects, a mixture of combined distilled essential oil will be sprayed on the label and outer cover of the bottles. participants, the principal investigator, health care personnel, those evaluating the outcome, the data safety and monitoring committee, and those drafting the article will be blinded
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Tabriz University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Floor 3, No 2 Central Building, Tabriz University of Medical Sciences, Golghasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2022-04-20, 1401/01/31
Ethics committee reference number
IR.TBZMED.REC.1401.089
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
RA01
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Hospitalization rate
Timepoint
After the intervention
Method of measurement
Questionnaire of clinical and paraclinical symptoms of the disease
2
Description
Mortality rate
Timepoint
After the intervention
Method of measurement
Questionnaire of clinical and paraclinical symptoms of the disease
Secondary outcomes
1
Description
The drug side effects rate
Timepoint
After intervention
Method of measurement
Side effects checklist
2
Description
Serum levels of ESR, CBC, LDH, SGPT, SGOT and BUN, Cr
Timepoint
Before and after the intervention
Method of measurement
Using biochemical methods in the autoanalyzer
3
Description
Rate of symptoms (dry cough, chills, sore throat, shortness of breath / difficulty breathing, temperature equal to 37.8, anorexia, gastrointestinal symptoms, loss of sense of smell and taste, ...)
Timepoint
During the intervention , 3 and 30 day after intervention
Method of measurement
Questionnaire of clinical and paraclinical symptoms of the disease
4
Description
Number of hospitalization days in hospitalized individuals
Timepoint
During the intervention
Method of measurement
Questionnaire of clinical and paraclinical symptoms of the disease
5
Description
ICU admission rate in hospitalized individuals
Timepoint
During the intervention
Method of measurement
Questionnaire of clinical and paraclinical symptoms of the disease
6
Description
Rate of need for ventilation in hospitalized people
Timepoint
During the intervention
Method of measurement
Questionnaire of clinical and paraclinical symptoms of the disease
7
Description
Satisfaction rate of the drug
Timepoint
During the intervention
Method of measurement
Checklist of side effects and drug satisfaction
Intervention groups
1
Description
Intervention group: Receiving 10 cc of curcuma herbal composition every 6 hours between meals asynchronously with other drugs for 10-14 days. This medicine will be produced in closed and dark bottles with a volume of 500 cc by Azar Tabib Cooperative Company.
Category
Treatment - Drugs
2
Description
Control group: Placebo Receiving in the form of a bottle containing Migliol oil (inert solution) which is completely similar in color and weight to curcuma and will be made in Tabib Cooperative Company. The placebo will be given to participants with the same prescription as the curcuma drug.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Asadabadi Hospital
Full name of responsible person
Mohammadreza Mirzaei
Street address
Near to the Agricultural Conservatory, Bahar Ave,
City
Tabriz
Province
East Azarbaijan
Postal code
5186637399
Phone
+98 41 3280 7263
Fax
+98 41 3280 7264
Email
dr.mirzaei_m@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
No. 2 Central building of the university, Golgasht Street, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadreza Mirzaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Medicine, Tabriz University of Medical Sciences,Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5186637399
Phone
0098 3335 7314
Email
dr.mirzaei_m@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadreza Mirzaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Medicine, Tabriz University of Medical Sciences,Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5186637399
Phone
+98 3335 7314
Email
dr.mirzaei_m@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadreza Mirzaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Medicine, Tabriz University of Medical Sciences,Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5186637399
Phone
0098 3335 7314
Email
dr.mirzaei_m@yahoo.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
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data on the main outcome will be published
When the data will become available and for how long
Six months after printing the results
To whom data/document is available
Researchers at institutions have access to data
Under which criteria data/document could be used
In order to help scientific progress in the field of research
From where data/document is obtainable
Dr.Mohammadreza Mirzaei dr.mirzaei_m@yahoo.com
What processes are involved for a request to access data/document
Scientific approval of the applicant by Tabriz University of Medical Sciences