Protocol summary
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Study aim
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Determining the effectiveness of "SALIRAVIRA" as a natural product containing of Licorice, Coneflower, Ginseng, Hyssop, Rhubarb and Rosemary extracts to coronavirus load in COVID-19 patients
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Design
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Randomized blind controlled trial with two parallel groups
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Settings and conduct
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Patients are recruited in the infectious diseases department of Imam Khomeini Hospital complex and a clinic; assigned in two parallel groups randomly.Participants and outcome evaluators are blind to the study
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: COVID-19 patient confirmed by positive PCR-viral load test, Having some or all of the symptoms include fever, fatigue, muscle aches ( body aches), headache, cough, chest tightness, and shortness of breath. Exclusion criteria: Malignant tumors and other acute systemic diseases and respiratory problems Life-threatening comorbidity, Use of any other herbal substance.Pregnancy, Lactation and drug and Alcohol addiction.
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Intervention groups
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Intervention group: Patients who receive "SALIRAVIRA" along with standard treatments as add on therapy. Control group: Patients who receive only standard treatments.
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Main outcome variables
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Viral clearance, Improving the symptoms of the disease such as fever and shortness of breath
General information
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Reason for update
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Addition a site for patient recruitment (Hospital)
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20201220049771N1
Registration date:
2020-12-31, 1399/10/11
Registration timing:
registered_while_recruiting
Last update:
2021-06-13, 1400/03/23
Update count:
2
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Registration date
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2020-12-31, 1399/10/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-12-21, 1399/10/01
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Expected recruitment end date
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2021-03-15, 1399/12/25
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Study of the effectiveness of "SALIRAVIRA" as a natural product containing Licorice, Cone flower, Ginseng, Hyssop, Rhubarb and Rosemary extracts on the recovery of COVID-19 patients
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Public title
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study of the effectiveness of "SALIRAVIRA" as a natural product on the treatment of COVID-19 patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Clinical confirmation of coronavirus infection
COVID-19 positive test reporting by RT-PCR
Cases with contact history with a COVID-19 patients in last 10 days
Lung involvement below 20% - Using CT-Scan
Exclusion criteria:
Pregnancy and Lactation cases
Cases with malignant tumors and other acute systemic diseases or special indication
Patients suffering from autoimmune diseases like Psoriasis, ALS and MS
Patients with comorbidity of respiratory life-threatening problems
Addiction to drugs and alcohol
Participation to another clinical trial for COVID-19
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Age
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From 12 years old to 80 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The participants will be assigned to two groups by block randomization method. In order to minimize the probability of sequence prediction, blocks with variable (4 and 6) size will be used. The randomization ratio will be 1:1. Randomization will be done using Random allocation software. Allocation concealment will be done by assigning unique codes.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-12-13, 1399/09/23
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Ethics committee reference number
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IR.SBMU.PHARMACY.REC.1399.276
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19 virus identified
Primary outcomes
1
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Description
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Viral Clearance
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Timepoint
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At the beginning of the study and and 4, 8 days after intake
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Method of measurement
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Polymerase chain reaction (PCR)
2
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Description
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Fever and symptoms
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Timepoint
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At the beginning of the study and daily during treatment after intake
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Method of measurement
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Using a thermometer and clinical diagnosis
3
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Description
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shortness of breath
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Timepoint
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At the beginning of the study and daily during treatment after intake
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Method of measurement
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Medical diagnosis
Secondary outcomes
1
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Description
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olfactory (sense of smell)
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Timepoint
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At the beginning of the study and daily during treatment after intake
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Method of measurement
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Questionnaire with interview
2
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Description
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sense of taste
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Timepoint
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At the beginning of the study and daily during treatment after intake
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Method of measurement
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Questionnaire with interview
Intervention groups
1
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Description
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Intervention group: Patients who receiving "SALIRAVIRA" containing mentioned extracts orally and respiratory spray at the same time in addition to standard treatments of COVID-19: 1- Oral; SALIRAVIRA tablet 750 mg; containing 500 mg of plant extracts mentioned before; 4 times daily, Once every 6 hours (tablets are packed in blisters contain 10 tablet and will be provided to each case for the duration of treatment, ie 32 tablet) All process of extraction, production and packaging done under GMP conditions in Mimdaroo pharmaceutical company. 2 - SALIRAVIRA respiratory spray (20ml), which contains plant extracts mentioned before will be used 4 times daily, once every 6 hours, spay will be used nasal or throat along with tablets. SALIRAVIRA spray contains 100mcl of plant extract per puff and its daily dose is 400 mcl based on references. All stages of production and packaging of SALIRAVIRA spray have been done under GMP conditions and in Mimdaroo Pharmaceutical company. The duration of treatment will be 8 days.
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Category
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Treatment - Drugs
2
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Description
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Control group: Patients receiving standard treatments for COVID-19 disease for 8 days. Standard treatment is determined according to the protocols and guidelines of the Ministry of Health and is performed in all centers.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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MimDaroo Pharmaceutical Company
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Data can be shared after de-identification
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When the data will become available and for how long
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Data will be available from April, 2030
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To whom data/document is available
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Academics employed at various research/university institutions and the industry.
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Under which criteria data/document could be used
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Using the de-identified data will be allow for scientific research by academics, including faculty members and students. In this case, by sending the request and reviewing it, the requested data will be provided.
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From where data/document is obtainable
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At first should refer to a person responsible for general inquiries of the clinical trial and then to the principal investigator.
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What processes are involved for a request to access data/document
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1- The applicant would be asked to provide a written formal request letter, containing the importance of the data .
2- Following the receipt of request letter, the data would be provided in no more than one week.
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Comments
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