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A clinical trial to study effect of Madhav Rasayan tablets in COVID 19 patients

Phase 3
Conditions
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Registration Number
CTRI/2020/11/029444
Lead Sponsor
Shri Vishwavati Ayurved Chikitsalaya and Research Centre
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Gender: Either male or non-pregnant, non-lactating female aged > 18-60 < years (both inclusive).

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

3. Subjects with mild to moderate COVID-19 infection having Respiratory rate >= 24/min and SpO2 > 90% on room air

4. Subjects willing to give written informed consent

5. Subjects able to take the drug 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 Subjects with persistent vomiting

2 Critically ill subjects

3 Patient with Shock

4 Subjects with known active hepatitis, tuberculosis

5 Subjects with altered mental state if on medication

6 Subjects with multiple organ failure requiring ICU monitoring and treatment

7 Subjects with respiratory failure and requiring mechanical ventilation

8 Subjects 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 Subjects with known history of serology tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus.

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

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

12 Pregnant and or lactating subjects

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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