Clinical trial of ACT 12 tablet and ACT 13 dry syrup in Covid 19 patients
Phase 2
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/07/026630
- Lead Sponsor
- Mr Ghanshyam Goti
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients admitted with RT-PCR confirmed COVID-19 illness
Age more than 18 & less than 65 years of either sex
Mild to Moderately Covid 19 disease (NEWS score less than or equal to 8)
Signed informed consent must be obtained and documented according to national/local regulations
Exclusion Criteria
Pregnant women
Breastfeeding women
Requiring ICU admission at screening
Patients above 65 years of age and below 18 Years
Past History of MI, Epileptic episodes
Any other co-morbidity (uncontrolled diabetes, severe hypertension from subject history) which
is at critical stage at screening
Any other condition by which subject proves unfit from investigator perspective
Not giving consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method o. of days for negative PCR confirmatory test from nasopharyngeal swab for COVID 19. <br/ ><br>Change in clinical symptom presentation in Cough, breathlessness, persistent pain and pressure <br/ ><br>in the chest, bluish discoloration of lips/ face on 5 point ordinal scale:None (1), mild (2), moderate (3), severe (4), extremely severe (5) <br/ ><br>Serum levels of CRP, IgM, IgG. <br/ ><br>Clinical status expressed in percentage of subjects on 6 point ordinal scale.Timepoint: Screening visit, Day 0, Day 4, Day 7 and Day 10 ie end of study
- Secondary Outcome Measures
Name Time Method Change in National Early Warning Score <br/ ><br>Hematological parameters like WBS, HB and platelet count etc. <br/ ><br>Requirement of admission to intensive care unit <br/ ><br>Reduced hospital duration <br/ ><br>Changes in biochemical parameters such as <br/ ><br>Lipid function test, liver function test, renal <br/ ><br>function test, electrolyte etc. <br/ ><br>Global assessment score for overall <br/ ><br>improvement by Investigator and subject <br/ ><br>Safety and tolerability of the interventionTimepoint: Screening visit, Day 0, Day 4, Day 7 and Day 10 ie end of study