Clinical trial of ShatPlus Advance in COVID 19 disease

A Double blind, randomized, placebo controlled clinical trial to evaluate safety and efficacy of ShatPlus Advance in mild to moderate patients with COVID 19 disease. - Nil

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/06/034131

Enrollment

Registered

2021-06-10

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 Advance along with standard treatment: 10 ml thrice a day ShatPlus Advance orally along with standard treatment for 10 days Control Intervention1: Placebo treatment along with

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age :18- 60 years (Both sex) 2.Confirmed COVID 19 diseases patient with positive RT-PCR 3.Mild to moderate disease (NEWS score 4.Patients willing to provide consent and follow up for study duration

Exclusion criteria

Exclusion criteria: 1.Patients with compromised immunity, autoimmune disease or self-reports HIV or syphilis infection 2.Proves to be unfit for the study as per the investigatorâ??s discretion 3.Pregnant or lactating women 4.Requiring supplemental oxygen and ICU admission at screening 5.Known case of comorbidity which is uncontrolled and which in investigator discretion finds patients not suitable for the trial participation 6.Any other medical condition like History of MI, Epileptic episodes finding patients not fit for trial participation

Design outcomes

Primary

Measure	Time frame
1.Percent population with negative RT PCR on day 4, 7 and 10. 2.Improvement of clinical symptoms- cough, breathlessness, fatigue, myalgia, headache, abdominal discomfort, persistent chest pain 3.Daily SpO2 levels 4.Requirements of supplemental oxygen 5.Reduction in elevated levels of inflammatory markers such as CRP, LDH, Ferritin, D-dimer and Interleukin 6 6.Changes in levels of Covid specific IgG antibodiesTimepoint: From baseline to end of study ie 10 days	—

Measure

Time frame

1.Percent population with negative RT PCR on day 4, 7 and 10. 2.Improvement of clinical symptoms- cough, breathlessness, fatigue, myalgia, headache, abdominal discomfort, persistent chest pain 3.Daily SpO2 levels 4.Requirements of supplemental oxygen 5.Reduction in elevated levels of inflammatory markers such as CRP, LDH, Ferritin, D-dimer and Interleukin 6 6.Changes in levels of Covid specific IgG antibodiesTimepoint: From baseline to end of study ie 10 days

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Secondary

Measure	Time frame
1.Changes in respiratory rate, pulse rate, blood pressure etc. 2.Requirement of admission to intensive care unit. 3.Duration of hospitalization. 4.Safety of intervention evident by adverse events 5.Changes in biochemical parameters such as liver, and renal function test, lipid profile and complete blood count, serum electrolytes (Sodium, potassium, chloride) etc.Timepoint: From baseline to end of study ie 10 days	—

Measure

Time frame

1.Changes in respiratory rate, pulse rate, blood pressure etc. 2.Requirement of admission to intensive care unit. 3.Duration of hospitalization. 4.Safety of intervention evident by adverse events 5.Changes in biochemical parameters such as liver, and renal function test, lipid profile and complete blood count, serum electrolytes (Sodium, potassium, chloride) etc.Timepoint: From baseline to end of study ie 10 days

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Countries

India

Contacts

Public ContactDr Pawan Kumar Singh

BVG Life Sciences Ltd

pawan.singh@bvglife.com9409616256

Outcome results

None listed

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