Evaluation the effect of Dinol herbal medicine on the improvement of clinical and paraclinical symptoms in hospitalized patients with COVID-19
Design
A randomized controlled, triple blinded clinical trial with a parallel-group design of 80 patients, which participants will be allocated into trial groups using Random Allocation Software (RAS)
Settings and conduct
This study is a randomized controlled triple blinded trial that will be conducted on COVID-19 patients who referred to 29 Bahman Hospital of Tabriz in two groups (intervention and control groups). The patients, researcher, monitoring committee, and statistical analyst will be blind to the received active drug or placebo. Participants will be allocated into trial groups randomly using Random Allocation Software (RAS). Patients will receive a sealed matte containers of Dinvl or placebo by giving 2 sublingual tablets every 6 hours for 7 days. Random allocation sequences will be generated by the non-involved person in the research. Both groups will receive routine treatments.
Participants/Inclusion and exclusion criteria
Patients aged 15 years and older with COVID-19 who had newly hospitalized; Having a definite disease; Having a signed informed consent form to participate in the study; and not participation in another clinical trial simultaneously.
Intervention groups
In the intervention group, participants will receive two 399±5 mg sublingual ِDinvl tablets containing 43.5 mg of herbal powder every 6 hours for 6 days (a total of 56 tablets per person) non-simultaneous with any other medications.The control group will receive a placebo, resembled ِDinvl tablets with the same prescription. Both groups will receive routine treatments.
Main outcome variables
Respiratory Rate (RR); Oxygen saturation (SpO2); Serum white blood cell count; serum CRP level; ٍُESR; the number of hospitalization days; Mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200518047497N2
Registration date:2020-06-06, 1399/03/17
Registration timing:prospective
Last update:2020-06-06, 1399/03/17
Update count:0
Registration date
2020-06-06, 1399/03/17
Registrant information
Name
Javad Amadian Heris
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 9151
Email address
ahmadianj@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-20, 1399/03/31
Expected recruitment end date
2020-08-20, 1399/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Dinvl medicinal herb on improving of clinical and paraclinical symptoms in patients with COVID-19 :A Randomized Controlled Trial
Public title
Effect of Dinvl on improving of clinical and paraclinical symptoms in patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
COVID-19 patients aged 15 years and older who newly admitted (first day of hospitalization)
Having definite COVID-19 disease
Obtaining informed consent to participate in the trial
Non-participation in another clinical trial simultaneously
Exclusion criteria:
Epilepsy
Having liver or renal failure according to the patient's statement, physician examination or based on creatinine, SGOT, SGPT, LDH tests.
Immunodeficiency (treated with Corticosteroids over 12.5 mg / d Prednisolone for more than two weeks, chemotherapy, malignancies, organ transplants, HIV patients, other viral diseases.
Having other infectious diseases according to the diagnosis of the physician and the information of medical record.
Pregnancy (according to the patient's statement and examination by a physician).
Breastfeeding (according to the patient's statement).
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be allocated to trial groups (intervention and placebo groups) randomly using Random Allocation Software (RAS) trough random block sizes of 4 and 6 with an allocation ratio of 1:1. Patients will receive a sealed containers of Dinvl sublingual tablets 399 ± 5 mg containing 43.5 mg of herbal powder or placebo made by Zahravi Pharmaceutical Company of Tabriz. Two sublingual tablets will be taken every 6 hour for 7 days (a total of 56 tablets for each person) not simultaneously with other any medications. Random sequencing allocation will be produced by the person who has not to participate in the research. Containers will be numbered from 1 to 80 according to the sequence generated. Both groups will receive routine treatments.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is a randomized controlled triple-blind clinical trial. This means that patient, researcher, safety and data monitoring committee, clinical caregiver and statistical analyst will be blind to the received medication. Each person will be given a opaque matte container of medicine containing herbal tablets of Dinolol or placebo in the identical shape, weight, smell and color.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2020-05-10, 1399/02/21
Ethics committee reference number
IR.TBZMED.REC.1399.135
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.01
ICD-10 code description
Novel Cronavirus Disease (COVID-19)
Primary outcomes
1
Description
Respiratory Rate
Timepoint
Daily
Method of measurement
Observation
2
Description
Oxygen saturation (SpO2)
Timepoint
Daily
Method of measurement
Pulse Oximeter
3
Description
Serum White Blood Cell count
Timepoint
Before- 14 days after intervention
Method of measurement
Laboratory cell counter
4
Description
Serum CRP level
Timepoint
Before- 14 days after intervention
Method of measurement
Biochemical method
5
Description
ESR (Erythrocyte Sedimentation Rate)
Timepoint
Before- 14 days after intervention
Method of measurement
Checking the sedimentation rate of erythrocytes in a special tube within one hour
6
Description
Number of hospitalization days
Timepoint
After intervention
Method of measurement
Questionnaire
7
Description
Mortality
Timepoint
Daily
Method of measurement
Questionnaire
Secondary outcomes
1
Description
The time of absence of dry Cough
Timepoint
Daily
Method of measurement
ِDaily symptom recording questionnaire
2
Description
The time of absence of trembling
Timepoint
Daily
Method of measurement
Daily symptom recording questionnaire
3
Description
The time of absence of sore throat
Timepoint
Daily
Method of measurement
Daily symptom recording questionnaire
4
Description
The time of absence of dry Cough
Timepoint
Daily
Method of measurement
Daily symptom recording questionnaire
5
Description
The time of absence of difficulty in breathing or shortness of breath
Timepoint
Daily
Method of measurement
Daily symptom recording questionnaire
6
Description
The time of absence of temperature equal to or grater than 37.8 C
Timepoint
Daily
Method of measurement
Daily symptom recording questionnaire
7
Description
Body temperature
Timepoint
Daily
Method of measurement
Thermometer
8
Description
Side effects
Timepoint
Daily
Method of measurement
Side effects checklist
Intervention groups
1
Description
Intervention group: In the intervention group, participants will receive Dinvl sublingual tablets 399±5 mg containing 43.5 mg of herbal powder made by Zahravi Pharmaceutical Company in Tabriz which will be taken every 6 hours for 7 days (a total of 56 tablets per person) not at the same time with other drugs. Both groups will receive routine treatments.
Category
Treatment - Drugs
2
Description
Control group: The control group will receive a placebo, resembled the Dinvl tablets with the same prescription. Both groups will receive routine treatments.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
29 Bahman Hospital
Full name of responsible person
Javad Ahmadian Heris
Street address
29 bahman Boulevard., Tabriz., East Azerbaijan Province
City
Tabriz
Province
East Azarbaijan
Postal code
5166617894
Phone
+98 41 3330 7000
Email
ahmadianj@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahravi Pharmaceutical Company
Full name of responsible person
Hamed Hamishekar
Street address
Serum Daroo street., 19 km of Tabriz-Tehran road., Tabriz,
City
Tabriz
Province
East Azarbaijan
Postal code
5166617894
Phone
+98 41 3630 9401
Fax
+98 41 3630 9400
Email
info@zahravipharma.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahravi Pharmaceutical Company
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
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Javad Ahmadian Heris
Position
Professor assistant of allergy and clinical immunology
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Sheshgelan., Tabriz., East Azerbaijan Province
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2280
Email
ahmadianj@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Javad Ahmadian Heris
Position
Professor assistant of allergy and clinical immunology
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Sheshgelan., Tabriz., East Azerbaijan Province
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2280
Email
ahmadianj@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Azizeh Farshbaf-Khalili
Position
Assistant Professor, Tabriz University of Medical Science
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht Street, Imam Reza Hospital, Ground Floor, Research Center of Physical Medicine and Rehabilitation
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 1928
Email
farshbafa@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Title and more details about the data/document
Effect of Dinvl medicinal herb on improving of clinical and paraclinical symptoms in patients with COVID-19 :A Randomized Controlled Trial
When the data will become available and for how long
End of august
To whom data/document is available
healthcare professional- َacademic members of universities
Under which criteria data/document could be used
An official request from the organization
From where data/document is obtainable
Tabriz University of Medical Sciences
What processes are involved for a request to access data/document
Request to Vice-Chancellor for Research and Technology Affairs