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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 criteria
Age 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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Collection: Clinical trial registers Database: ICTRP Year: 2020 Document Type: Clinical Trial Register