A clinical trial to know the efficacy and safety of herbal product Virowin in combination with Energy-Z capsule in treating mild to moderate COVID-19 patients.

Phase 3

Completed

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

• Registration Number: CTRI/2020/08/027120
• Lead Sponsor: Amulya Herbs

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-11-24
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

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

Inclusion Criteria

1. Gender: Either male or non-pregnant, non-lactating female aged > 18-70 < years (both inclusive).

2. Patients with RT-PCR confirmed diagnosis of COVID-19

3. Patients with mild to moderate COVID-19 infection

4. Subjects willing to give written informed consent

5. Subjects able to take the Product orally and comply with the study protocol

6. Women of child bearing potential must have a negative urine pregnancy test prior to study entry

Exclusion Criteria

1.Patients with persistent vomiting

2.Critically ill patients

3.Patients with known active hepatitis, tuberculosis and definite bacterial or fungal infections

4.Patients with altered mental state

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

6.Patients with respiratory failure and requiring mechanical ventilation

7.Patients with shock

8.Patients with any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g. heart failure, hypertension, liver disease, diabetes, anemia etc.) that, in the opinion of investigator precludes the subjectâ??s participation in the study or interferes with the interpretation of the study results.

9.Patients with history of serology tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus.

10.Patients who have received specific antiviral drugs ritonavir/lopinavir, or chloroquine, hydroxychloroquine, azithromycin, monoclonal antibodies within 1 week before admission

11.Patient who have participated in another investigational study within 3 months prior to enrolment in this study

12.Investigators, study personnel, sponsorâ??s representatives and their first-degree relatives.

13.Pregnant subjects

Study & Design

• Study Type: Interventional
• Study Design: Not specified