Clinical trial of ShatPlus as an immunomodulator in adult Covid 19 positive patients

Phase II, open label, randomized controlled trial to evaluate safety and efficacy of ShatPlus as an immunomodulator in adult Covid 19 positive patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/06/025999

Enrollment

Registered

2020-06-21

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: ShatPlus along with standard treatment: 10 ml thrice a day per oral ShatPlus along with standard treatment Control Intervention1: Standard treatment: Standard treatment as per protocol

Eligibility

Inclusion criteria

Inclusion criteria: Patients admitted 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 AYUSH GCP, and 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 Serum levels of CD4, CD8, NK cell panel CD16/CD56, CRP, IgM, IgG Clinical status expressed in percentage of subjects reporting each severity rating on a 6-point ordinal scale Timepoint: Screening visit, Day 0, Day 4, Day 7 and Day 10 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 Serum levels of CD4, CD8, NK cell panel CD16/CD56, CRP, IgM, IgG Clinical status expressed in percentage of subjects reporting each severity rating on a 6-point ordinal scale Timepoint: Screening visit, Day 0, Day 4, Day 7 and Day 10 end of study

—

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 Total days admitted to the hospital (difference between admission date and discharge date of index admission) Safety and tolerability of the intervention Changes in biochemical parameters such as Lipid function test, liver function test, renal function test, electrolyte etc.Timepoint: Screening visit, Day 0, Day 4, Day 7 and Day 10 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 Total days admitted to the hospital (difference between admission date and discharge date of index admission) Safety and tolerability of the intervention Changes in biochemical parameters such as Lipid function test, liver function test, renal function test, electrolyte etc.Timepoint: Screening visit, Day 0, Day 4, Day 7 and Day 10 end of study

—

Countries

India

Contacts

Public ContactDr Pawan Kumar Singh

BVG Life Sciences Ltd. (BVG Group)

pawan.singh@bvglife.com9409616256

Outcome results

None listed

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