A study of Ayurvedic medicine â??CoReachâ?? in COVID-19 positive patients.

Not Applicable

Completed

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

• Registration Number: CTRI/2021/05/033626
• Lead Sponsor: Questt Clinicals and Ayurceuricals Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-07-23
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 106

Inclusion Criteria

I. Patients with laboratory confirmation of infection with SARS CoV-2 by positive RT-PCR or Rapid Antigen Test with mild to moderate symptoms (Mild: Upper respiratory tract symptoms (& or fever) WITHOUT shortness of breath or hypoxia

Moderate: Any one of: 1. Respiratory rate > 24/min, breathlessness 2. SpO2: 90% to < 93% on room air

Ref: AIIMS ICMR-COVID-19 National Task Force)

Patients progressing from moderate to severe grade during treatment will be withdrawn from the study

II. Age >18 and < 75 years at the time of signing ICF

III. Voluntarily participation in the clinical trial and agreeing to follow study procedures

IV. Not participating in any other interventional drug clinical studies before completion of the present study

V. Ready to give medical data for assessments

Exclusion Criteria

I. Critical infection, defined as need for invasive ventilator support

II. Inability to intake or tolerate oral medications.

III. Known pregnant or lactating women

IV. Persons with severe primary respiratory disease or other pneumonia

V. Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess percentage of patients with 2 points improvement or becoming asymptomatic (Grade 2 or less) on the modified ordinal scale for clinical improvementTimepoint: Day 4

Secondary Outcome Measures

Name	Time	Method
Efficacy of Tab. CoReach in getting RT-PCR negative status earlierTimepoint: -;Efficacy of Tab. CoReach in normalizing cytokinesTimepoint: -;Improvement in Oxygen saturationTimepoint: -;Incidence of adverse events and treatment emergent adverse events during treatment periodTimepoint: Throughout study