Clinical trial on post covid patients

Phase 3

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

Registration Number: CTRI/2022/07/043655

Lead Sponsor: Zum Heilen Diagnostic and Therapeutics Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

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.Previously positive COVID cases along with comorbidity conditions

4.Can take oral medicines

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

Exclusion Criteria

1.Patients who are tested to be COVID-19 positive, at the time of enrollment in the study.

2.Patient with previous history of serious COPD, Asthma, Bronchiectesis and Chronic Cardiac ailments

3.Pregnant and lactating women

4.Patients who are not willing to volunteer for the study.

5.Patients developing serious complications, Immuno-compromisedpatients

6.Idiosyncratic reactions, severe medicinal aggravation and requiring ventilator support or emergency surgical intervention.

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

8.Any uncontrolled systemic disease, infection

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

10.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
1.To assess persistent symptoms in patients who were recovery from SARS COV 2 infection from Base line to Day 21 <br/ ><br>2.Improvement in the clinical features from baseline to end of the study period <br/ ><br>3.Change in immune markers (IL6, IL10 and TNF-alpha) levels from baseline to Day 21 <br/ ><br>4.Subject and Investigator Assessment Long COVID Questionnaire provided by ICMR <br/ ><br>Timepoint: IL6, IL10 and TNF-alpha: Day 0 and Day 21 <br/ ><br>clinical features : Day 0 to Day 90 <br/ ><br> <br/ ><br>Subject and Investigator Assessment Long COVID Questionnaire : Day 0,Day 30,Day 6 and Day 90

Secondary Outcome Measures

Name	Time	Method
1.To assess the effect on quality of life of patients recovered from covid-19 from Base line to Day 90 <br/ ><br>2.Adverse events (AEs), frequency and severity from Base line to Day 90 <br/ ><br>Timepoint: Day to Day 90