Effect of Ayurvedic Treatment Regimen in COVID-19 Patients

Phase 3

Completed

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

• Registration Number: CTRI/2020/10/028437
• Lead Sponsor: Ministry of AYUSH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-06-22
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 390

Inclusion Criteria

1. All hospitalized cases above 18 years of age, clinically diagnosed with corona virus disease 2019 and presenting with mild to moderate signs and symptoms of COVID-19, quarantined at identified hospital set up.

2. Participants who can take medicines orally.

3. Patients willing to provide signed informed consent.

Exclusion Criteria

1. Cases of severe vomiting which would affect oral administration of medicine difficult.

2. Cases of respiratory failure and requiring mechanical ventilation.

3. Combined organ failure requiring ICU monitoring.

4. Pregnant and lactating women.

5. Subjects having an active malignancy.

6. Subjects giving history of significant cardiovascular event < 12 weeks prior to randomization.

7. Subjects having a chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.

8. Subjects having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.

9. Any other condition, which as per the investigator would jeopardize the outcome of the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Clinical cure rate: Time to negative conversion of severe acute respiratory syndrome corona-virus 2 (defined as viral load of respiratory specimen negative for two consecutive times when tested in an interval of two days)Timepoint: 3 Months

Secondary Outcome Measures

Name	Time	Method
1. Length of stay in hospital <br/ ><br>2. Duration of fever and respiratory symptoms <br/ ><br>3. Improvement in hematological and laboratory parameters (Hs-CRP, ESR, TC, DC, Absolute lymphocyte count, LFT, RFT, IL-6, Ig E, Ig-G,Ig-M, LDH, Creatine Kinase, Platelet count), <br/ ><br>4. Frequency of ADR/AE <br/ ><br>5. Number of cases that required oxygen therapy during the intervention.Timepoint: 3 Months