Clinical trial of ACT 12 tablet and ACT 13 dry syrup in Covid 19 patients

Phase II, open label, randomized controlled trial to evaluate safety and efficacy of ACT 12 tablet and ACT 13 dry syrup as an immunomodulator in adult Covid 19 positive patients

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/07/026630

Enrollment

Registered

2020-07-16

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: ACT 12 tablet and ACT 13 dry syrup: 2 tablets of ACT12 and 20 ml ACT 13 dry syrup thrice a day along with standard of care for 10 days Control Intervention1: Standard treatment: Standar

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
No. of days for negative PCR confirmatory test from nasopharyngeal swab for COVID 19. Change in clinical symptom presentation in Cough, breathlessness, persistent pain and pressure in the chest, bluish discoloration of lips/ face on 5 point ordinal scale:None (1), mild (2), moderate (3), severe (4), extremely severe (5) Serum levels of CRP, IgM, IgG. 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	—

Measure

Time frame

No. of days for negative PCR confirmatory test from nasopharyngeal swab for COVID 19. Change in clinical symptom presentation in Cough, breathlessness, persistent pain and pressure in the chest, bluish discoloration of lips/ face on 5 point ordinal scale:None (1), mild (2), moderate (3), severe (4), extremely severe (5) Serum levels of CRP, IgM, IgG. 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

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Secondary

Measure	Time frame
Change in National Early Warning Score Hematological parameters like WBS, HB and platelet count etc. Requirement of admission to intensive care unit Reduced hospital duration Changes in biochemical parameters such as Lipid function test, liver function test, renal function test, electrolyte etc. Global assessment score for overall improvement by Investigator and subject Safety and tolerability of the interventionTimepoint: Screening visit, Day 0, Day 4, Day 7 and Day 10 ie end of study	—

Measure

Time frame

Change in National Early Warning Score Hematological parameters like WBS, HB and platelet count etc. Requirement of admission to intensive care unit Reduced hospital duration Changes in biochemical parameters such as Lipid function test, liver function test, renal function test, electrolyte etc. Global assessment score for overall improvement by Investigator and subject Safety and tolerability of the interventionTimepoint: Screening visit, Day 0, Day 4, Day 7 and Day 10 ie end of study

—

Countries

India

Contacts

Public ContactDr Pawan Kumar Singh

Gplife Healthcare Pvt Ltd

gplifehealthcare@gmail.com9824917109

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026