Protocol summary
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Study aim
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Assessment of the effect of Iranian medicine product, SINA anti-flu, on the symptoms of patients with covid-19 (Coronavirus 19 disease)
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Design
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This clinical trial has control group, and with parallel groups, double blinded, randomized, phase 2 to 3 and is performed on 80 patients. Randomization method will be blocked randomization (Quaternary random blocks).
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Settings and conduct
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Patients in the drug group take the Iranian traditional drug for ten days and 4 times from syrup and 2 times from drop daily In addition to the usual medicines (According to the protocol of the Ministry of Health). Patient in control group use routine treatment and placebo. The study is performed in Baqiyatallah Hospital.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Male or female patients 18 years old and older with COVID-19, positive coronavirus 19 PCR, Ground glass view at low-dose CT scan, Arterial oxygen saturation less than 93%, Consciously completed consent form completed by the patient or the patient's supervisor. Exclusion criteria: History of pulmonary malignancy, History of asthma or COPD, History of Disabling disease or malignancy, Liver or kidney disorders.
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Intervention groups
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Intervention groups will be two ones.Patients in the intervention group will receive the intervention drug (syrup & drop) in addition to the routine treatment, but in control group, they will receive placebo in addition to the routine treatment.
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Main outcome variables
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3D lung CT Scan, dyspnea, cough, arterial oxygen saturation, PCR, CBC diff
General information
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Reason for update
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changing in email address
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160131026298N5
Registration date:
2020-08-23, 1399/06/02
Registration timing:
prospective
Last update:
2025-01-02, 1403/10/13
Update count:
4
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Registration date
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2020-08-23, 1399/06/02
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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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2020-09-22, 1399/07/01
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Expected recruitment end date
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2021-03-19, 1399/12/29
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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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Evaluation of the effect of SINA anti-flu syrup and drop on respiratory quality in COVID-19 ; A double-blind study
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Public title
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Evaluation of the effect of SINA anti-flu natural product on COVID-19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Male or female patients 18 years old and older with COVID-19
positive coronavirus 19 PCR Ground glass view at low-dose CT scan
Arterial oxygen saturation less than 93%
Consciously completed consent form completed by the patient or the patient's supervisor
Exclusion criteria:
History of pulmonary malignancy
History of asthma or COPD
History of Disabling disease or malignancy
Liver or kidney disorders
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Age
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From 18 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization method will be blocked randomization (Blocks of size 4). Randomization units are individuals. Eighty outpatients referred to the hospital emergency department are randomly assigned to one of the two intervention and control groups according to form of random string produced by online random allocation .
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Study participants, the clinical observer, the data collector, and the data analyzer are kept blind to the study groups. Blinding will be done using a placebo in the control group.
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Placebo
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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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2020-03-29, 1399/01/10
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Ethics committee reference number
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IR.BMSU.REC.1399.156
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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U07.2
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ICD-10 code description
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U07.2 COVID-19, virus not identified, COVID-19
Primary outcomes
1
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Description
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Measurement of cough severity
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Timepoint
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Day 1 before and at the end of treatment
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Method of measurement
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Standard cough questionnaire
2
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Description
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severity of shortness of breath
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Timepoint
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Day 1 before and at the end of treatment
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Method of measurement
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Shortness Of Breath With Daily Activity (SOBDA) Questionnaire
3
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Description
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lung radiologic changes
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Timepoint
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At beginning and end of the study
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Method of measurement
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Chest CT scan
Intervention groups
1
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Description
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Intervention group: The product includes herbal syrup (Echinacea, thyme, hyssop, Chebulic Myrobaan), honey and glycyrrhizin drop.Dosage of syrup: every 6 hours;10 cc. Dosage of drop: 20 drops after lunch and dinner. In the intervention group, conventional medicine is used according to the latest protocol of the Ministry of Health at the begining of the study (Azithromycin 250mg once a day and naproxen 250mg twice a day).
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Category
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Treatment - Drugs
2
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Description
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Control group: In this group, the common drug is used according to the latest protocol of the Ministry of Health at the begining of the study that is similar to the common drug medicine in the herbal product group.
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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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Yes
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Title of funding source
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Dina Pharmed Exir Salamat Co
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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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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available