Prospective on evaluation of use of , â??AyurCoro3â?? as an add on medication for the treatment purpose in COVID-19 patients

Phase 3

Completed

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

• Registration Number: CTRI/2020/10/028333
• Lead Sponsor: Shri Sarveshwar Seva Sahkari Samstha

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-02-26
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 174

Inclusion Criteria

1. Laboratory confirmed diagnosis of Mild to Moderate COVID-19 patients

2. Agree to consent for the study.

3. All Age groups above 18 Years

4. All genders.

Exclusion Criteria

1.Patients on ventilator

2.Critically ill patient

3.Dyspnea, respiratory frequency >= 30/min,

4.Blood oxygen saturation (SpO2) <= 90%,

5.PaO2/FiO2 ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours

6.Patients with altered mental state

7.Patients with multiple organ failure requiring ICU monitoring and treatment.

8.Patients with respiratory failure and requiring mechanical ventilation/

9.Patient who have participated in another investigational study within 3 months prior to enrollment in this study

10.Investigators, study personnel and their first-degree relatives.

11.Pregnant Patients

12.Current or future involvement in the active treatment phase of other interventional research studies (excluding observational/non-interventional studies).

13.Any other clinical reason which may preclude entry in the opinion of the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time (Days) to clinical improvement from study enrolmentTimepoint: At Baseline, Day three , Day five and Day seven

Secondary Outcome Measures

Name	Time	Method
1.Clinical status as assessed by the 9-point ordinal scale <br/ ><br>2.Duration of hospitalization <br/ ><br>3.Proportion of participants in each group with need for mechanical ventilation <br/ ><br>4.Rate of patients showing improvement of 2 points in 7 category ordinal scale <br/ ><br>5. Functional status scale -post covid-19 at 1 week post discharge Follow up visit <br/ ><br>Timepoint: At Baseline, Day three , Day five and Day seven and at Discharge