Evaluation of the effect of Traditional medicine product incorporated in the base of Astragalus gossypinus with food spice on improvement of clinical menifestation of COVID -19 patients with conventional protocol
Evaluation of the effect of Traditional Medicine product incorporated in the base of Astragalus gossypinus with food spice on improvement of clinical menifestation of COVID-19 patients with conventional protocol
Design
This study is a randomized, controlled, double-arm clinical trial. Eighty patients will be included in the study .Physicians who assess outcomes and the statistician analyzing the data all will be blinded
Settings and conduct
This study will be conducted in Kerman hospitals. In the intervention group, 40 patients with COVID-19 receive in addition to standard treatment, traditional medicine protocols including traditional syrup and food spice . Forty patients in the control group received standard treatment only.
Participants/Inclusion and exclusion criteria
Inclusion criteria: confirmed cases of COVID-19 infection with specialist on the base of CT and pharyngeal specimen; Exclusion criteria: Pregnancy, Breastfeeding
Intervention groups
Intervention group received standard treatment with traditional medicine protocol including traditional syrup based on Astragalus gossypinus a rate of 10 cc daily for two hours on the first and second days and 10 cc on the following days.Contemporary Patients receive 2 grams of herbal spice food with a apple juice daily after breakfast.Patients in the control group will receive only the standard treatment.
Main outcome variables
Significant clinical symptoms and vital signs : Clinical recovery up to 10 days from initiation of study treatment until normalization of fever (≤37.2 °C oral), respiratory rate (≤24/minute on room air), and oxygen saturation (>94% on room air), and alleviation of cough (mild or absent on a patient reported scale), sustained for at least 24 hours.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101219005416N2
Registration date:2020-04-03, 1399/01/15
Registration timing:registered_while_recruiting
Last update:2020-04-03, 1399/01/15
Update count:0
Registration date
2020-04-03, 1399/01/15
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
03412266914
Email address
h_tajadini@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-24, 1399/01/05
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Traditional medicine product incorporated in the base of Astragalus gossypinus with food spice on improvement of clinical menifestation of COVID -19 patients with conventional protocol
Public title
Evaluation of the effect of traditional Iranian medicine product on improvement of clinical menifestation of COVID -19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients that confirmed COVID- 19 with specialist on the base of CT changing and pharyngeal specimen
Exclusion criteria:
Lack of informed consent
Pregnancy
Breastfeeding
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by permutation randomized block method in four-sided blocks. The construction of blocks is done with R version software 2, 3, 6.
Blinding (investigator's opinion)
Double blinded
Blinding description
The treatment assignment will remain unknown until the patient is randomized. Physicians who treat patients and the patients will not be blinded. Radiologists, physicians who assess outcomes and the statistician analyzing the data all will be blinded
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Deputy of Research and Technology;ebne-e-Sina St.,Jahad Blvd., Kerman,Iran
City
kerman
Province
Kerman
Postal code
7619813159
Approval date
2020-03-21, 1399/01/02
Ethics committee reference number
IR.KMU.REC.1399.003
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
Confirmed COVID-19
Primary outcomes
1
Description
Response to the treatment (Significant clinical improvement)
Timepoint
At baseline and daily
Method of measurement
According to the clinical, paraclinical and laboratory findings. Clinical improvement: normalization of the body temperature (≤37.2 ° C), respiratory rate (≤24 breaths per minute), oxygen saturation (> 94% at room temperature) and cough ; dyspnea ; headche and dirrhea that will measure on a qualitative scale based on the patient's report . Other outcome variables will measure during clinical examination.
Secondary outcomes
1
Description
Duration of hospitalization
Timepoint
End of the treatment
Method of measurement
Patient's medical record
2
Description
Mortality
Timepoint
End of the treatment
Method of measurement
Patient's medical record (Clinical outcome)
Intervention groups
1
Description
Intervention group: Patients admitted to hospital in addition to receiving standard treatments of the Corona Country Committee, received a traditional product based on Astragalus gossypinus of 10 cc daily for 2 hours and food spice based on Ferula assa-foetida of 2 grams once a day with apple juice. Traditional protocol duration is 5 days.
Category
Treatment - Drugs
2
Description
Control group: Hospitalized patients are receiving standard corona treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzali pour Hospital
Full name of responsible person
Haleh Tajadini
Street address
No. 9, Jahad Av19 ., Kerman
City
Kerman
Province
Kerman
Postal code
7619837773
Phone
+98 34 3243 5539
Email
drhalehtajadini@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abas Pardakhti
Street address
Ebn-e-Sina St.,Jahad Blvd., Kernan,Iran
City
کرمان
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3719
Fax
+98 34 3226 3857
Email
drhalehtajadini@gmail.com
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
Haleh Tajadini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 9, Jahad 19, Kerman
City
Kerman
Province
Kerman
Postal code
7619837773
Phone
+98 34 3243 5539
Email
drhalehtajadini@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Haleh Tajadini
Position
Asisstante Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
NO.9, Jahad 19, Kerman,Iran
City
Kerman
Province
Kerman
Postal code
7619837773
Phone
00343243539
Email
drhalehtajadiny@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Haleh Tajadini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
NO.9, 19 Ave., Jahad Blvd.,Kerman Town
City
Kerman
Province
Kerman
Postal code
7619837773
Phone
000983432435539
Email
drhalehtajadini@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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available