Investigating the efficacy of Provita Capsule in controlling the symptoms of patients with COVID-19
IRCT; 2020-05-28; TrialID: IRCT20080901001165N60
Clinical Trial Register
| ICTRP | ID: ictrp-IRCT20080901001165N60
ABSTRACT
Condition
COVID-19.Covid-19;U07.1
Intervention
Intervention 1 Intervention group Provita Capsule (each capsule contain vitamin A, E, D, C, B family, Zn, Se, Para-biotic, and inactive ingredients, produced by Tak-Gen-Zist pharmaceutical company, Iran) 1 capsule, every 12 hours, for 21 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus). Intervention 2 Control group Placebo Capsule(contain inactive ingredients similar to Provita's inactive ingredients, produced by Tak-Gen-Zist pharmaceutical company, Iran), 1 capsule, every 12 hours, for 21 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus.).Primary outcome:
Clinical symptoms (dry cough). Timepoint Daily monitoring at the hospitalization, but the result of baseline (before the initiation of intervention), and day 7 and day 21 from the initiation, is recorded. Method of measurement Physical examination,questionnaire.;Clinical symptoms (respiratory distress). Timepoint Daily monitoring at the hospitalization, but the result of baseline (before the initiation of intervention), and day 7 and day 21 from the initiation, is recorded. Method of measurement Pulse-oxymetery device.;Clinical symptoms (fever). Timepoint Daily monitoring at the hospitalization, but the result of baseline (before the initiation of intervention), and day 7 and day 21 from the initiation, is recorded. Method of measurement Thermometer.Criteria
Inclusion criteriaAge equal or more than 18 years;
The patient have written consciously and freely consent to participate in the study;
The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19.
Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation.
Less than 7 days have passed since the onset of symptoms.
Exclusion criteria
History of allergy to the ingredients;
The patient is in another clinical trial at the same time;
The patient needs to receive medical care from the intensive care unit;
Pregnancy;
Lactation.
Impossibility of oral nutrition;
Collection:
Clinical trial registers
Database:
ICTRP
Year:
2020
Document Type:
Clinical Trial Register
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