Clinical trial of GP/AYU/2021/001 Kit in patients with Covid 19.

A Double blind, randomized, placebo controlled clinical trial to evaluate safety and efficacy of GP/AYU/2021/001 Kit in patients with SARS-CoV-2 Infection. - NA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/08/036010

Enrollment

300

Registered

2021-08-27

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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: COROPROTECT TABLET and COROPROTECT DRY SYRUP: 2 tablets twice a day and 10 ml syrup thrice a day along with standard of care for 10 days Control Intervention1: Standard of care: Standar

Eligibility

Inclusion criteria

Inclusion criteria: Patients with RT-PCR confirmed COVID-19 illness 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 the critical stage at a screening Any other condition by which subject proves unfit from the investigator perspective Not giving consent.

Design outcomes

Primary

Measure	Time frame
No. of days for negative RTPCR confirmatory test from nasopharyngeal swab for SARS-Covid 2. Change in clinical symptom presentation in cough, breathlessness, fatigue, persistent pain and pressure in the chest on 5-point ordinal scale: None (1), mild (2), moderate (3), severe (4), extremely severe (5) Serum CRP, LDH, Ferritin, Interleukin 6. Immunity Panel levels (CD3, CD4, CD8)Timepoint: From baseline to day 10	—

Measure

Time frame

No. of days for negative RTPCR confirmatory test from nasopharyngeal swab for SARS-Covid 2. Change in clinical symptom presentation in cough, breathlessness, fatigue, persistent pain and pressure in the chest on 5-point ordinal scale: None (1), mild (2), moderate (3), severe (4), extremely severe (5) Serum CRP, LDH, Ferritin, Interleukin 6. Immunity Panel levels (CD3, CD4, CD8)Timepoint: From baseline to day 10

—

Secondary

Measure	Time frame
Plasma levels of COVID Antibodies. Clinical status expressed in percentage of subjects reporting each severity rating on a 6-point ordinal scale. Change in National Early Warning Score. Hematological parameters like WBS, RBC and platelet count etc. Requirement of admission to intensive care unit. Duration of hospitalization Safety parameters like CBC and blood biochemistry.Timepoint: From baseline to day 10	—

Measure

Time frame

Plasma levels of COVID Antibodies. Clinical status expressed in percentage of subjects reporting each severity rating on a 6-point ordinal scale. Change in National Early Warning Score. Hematological parameters like WBS, RBC and platelet count etc. Requirement of admission to intensive care unit. Duration of hospitalization Safety parameters like CBC and blood biochemistry.Timepoint: From baseline to day 10

—

Countries

India

Contacts

Public ContactMr Chetan savaliya

Gplife Healthcare Pvt Ltd

gplifehealthcare@gmail.com

Outcome results

None listed

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