Cardamom Extract Clinical trial on Covid patients

Phase 3

Conditions: Health Condition 1: - Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere

Registration Number: CTRI/2021/01/030601

Lead Sponsor: Zum Heilen Diagnostic Therapeutics ZH DT

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Subjects aged 18-65 years of age and of either sex

2.Subjects who are willing to give consent to the study

3.COVID-19 positive clinical symptoms and (subsequently) confirmed by the current recommended confirmatory test (RT-PCR).

4.Mild to Moderate disease (NEWS score Less than/equal to 8)

5.Can take oral medicines

6.Subject willing to abide by and comply with the study protocol.

Exclusion Criteria

1.Age less than 18 years and more than 65 years

2.Pregnancy and lactation

3.Severe or complicated course of COVID-19 disease

4.Presence of acute hypoxic respiratory failure/ need for Intensive care unit (ICU) stay/ Patients who need mechanical ventilation.

5.Any uncontrolled systemic disease, infection

6.Those with serious Cardiovascular, Cerebrovascular, Respiratory, Liver or Renal disease or any other disorder.

7.Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â?¢Change in Chest CT severity score (CO-RADS) from baseline to day 7 <br/ ><br>â?¢Change in Viral load from baseline to day 7 <br/ ><br>â?¢Change in immune markers (IL-6, LDH, TNF, TLC, ALC, FERRITIN, CRP and D-DIMER) from baseline to day 7 <br/ ><br>Timepoint: Day 0 and Day 7

Secondary Outcome Measures

Name	Time	Method
â?¢Change in National Early Warning Score (NEWS) from baseline to day 7 <br/ ><br>â?¢Change in clinical symptoms on 5 point ordinal scale from baseline to day 7 <br/ ><br>â?¢Number of patients tested COVID 19 RT-PCR negative at day 7 <br/ ><br>â?¢Number of patients requiring intensive care treatment (ICU) at day 7 <br/ ><br>â?¢Number of patients requiring Ventilator support at day 7 <br/ ><br>Timepoint: Day 0 and Day 7