Panchgavya Therapy in prophylaxis and as an adjuvant therapy in management of Covid 19.

Phase 2

Completed

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

• Registration Number: CTRI/2020/07/026793
• Lead Sponsor: Ionisation Filtration Industries PvtLtd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-12-15
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Patients with RT-PCR confirmed COVID-19 illness.

Age of 18-65 years of either sex (Both including)

Mild to Moderate Covid 19 disease (NEWS score NMT 7)

Signed informed consent.

Cases with or without presenting with fever and/or upper respiratory tract illness (Influenza-like illness, ILI).

Subjects at high risk of exposure to COVID 19

Health care and frontline workers involved in the treatment of COVID19 cases

Family members of COVID19 cases or direct contact

Exclusion Criteria

Subjects with any comorbidity which is critical at the screening

Allergies, known to be allergic to research drugs

Confirmed pneumonia cases with or without symptoms

Patients who have participated in other clinical trials within 1 month

Proves unfit for the study as a sole discretion of the investigator

Being pregnant or breastfeeding

Requiring ICU admission at the screening

Past History of MI, Epileptic episodes

Not giving consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
% of subjects with negative RT-PCR for COVID 19 at the end of study <br/ ><br>Change in clinical symptom presentation in Cough, breathlessness, persistent pain and pressure in the chest, loss of appetite, fatigue on 5 point ordinal scale-None, mild, moderate, severe , extremely severe <br/ ><br>Clinical status expressed in percentage of subjects reporting each severity rating on a 5-point ordinal scaleTimepoint: 24 hrs. of treatment regimen, patient to be observed daily for till the time of discharge or day 10 whichever is earlier

Secondary Outcome Measures

Name	Time	Method
Change in National Early Warning Score (SpO2, respiratory rate, heart rate, fever) <br/ ><br>Requirement of admission to intensive care unit <br/ ><br>No. of days of hospitalization <br/ ><br>Requirement of hospitalizationTimepoint: 24 hrs. of treatment regimen, patient to be observed daily for till the time of discharge or day 10 whichever is earlier