Investigating the effects of Zofa (a herbal composition) on the clinical symptoms
Investigating the effects of Zofa (a herbal composition) on the laboratory findings
Design
This study is a single-center, prospective, randomized, open-labeled, controlled,parallel phase 3 clinical trial.
Settings and conduct
Patients who is admitted to Baqiyatallah hospital, and is meet the inclusion criteria, is entered to the study are randomly assigned into two groups of intervention and control.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
age equal or more than 18 years;
The patient have written consciously and freely consent to participate in the study.
Confirmed diagnosis of COVID-19, with Laboratory (RT-PCR) confirmation.
Confirmed diagnosis of COVID-19, with lung CT-Scan result, which is typical for COVID-19 pulmonary involvement.
The patient has clinical symptom of COVID-19 (dry cough, respiratory distress, fever)
Less than 7 days have passed since the onset of symptoms;
Exclusion Criteria:
The patient needs to receive medical care from the intensive care unit.
The patient is in another clinical trial at the same time.
Intervention groups
intervention group: Syrup Zofa 10 ml every 8 hours for 7 days, in addition to routine treatment according to the latest national guideline for the treatment of new corona-virus
Control group: routine treatment according to the latest national guideline for the treatment of new corona-virus
Investigating the efficacy of Zofa (a herbal medicine) in symptom management of patients with COVID-19
Public title
Investigating the efficacy of Zofa (a herbal medicine) in symptom management of patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age equal or more than 18 years;
The patient have written consciously and freely consent to participate in the study.
Confirmed diagnosis of COVID-19, with Laboratory (RT-PCR) confirmation.
Confirmed diagnosis of COVID-19, with lung CT-Scan result, which is typical for COVID-19 pulmonary involvement.
The patient has clinical symptom of COVID-19 (dry cough, respiratory distress, fever)
Less than 7 days have passed since the onset of symptoms;
Exclusion criteria:
The patient is in another clinical trial at the same time.
The patient needs to receive medical care from the intensive care unit
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization method is used to randomized the patients.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Science
Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded.
Method of measurement
Physical examination,questionnaire
2
Description
clinical symptoms (respiratory distress)
Timepoint
Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded.
Method of measurement
pulse oxymetery device
3
Description
clinical symptoms (fever)
Timepoint
Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded.
Method of measurement
Thermometer
Secondary outcomes
1
Description
lab tests changes
Timepoint
daily monitoring, but the before the intervention initiation (baseline) and day 7 results will recorded on designed checklist.
Method of measurement
blood sample, laboratory analysis
Intervention groups
1
Description
Intervention group: Syrup Zofa 10 ml every 8 hours, for 7 days. (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus)
Category
Treatment - Drugs
2
Description
Control group: Routine treatment according to the latest national guideline for the treatment of new corona-virus