Clinical trial on respiratory illness patients

Phase 3

Conditions: Health Condition 1: J208- Acute bronchitis due to other specified organisms

Registration Number: CTRI/2021/03/032056

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.Age group 19 â?? 70 yrs

2.Subjects of both male and females involved

3.Patients with acute respiratory infections

4.Subjects who are willing to provide written consent for the study

5.Mild to Moderately severe disease (NEWS score Less than/equal to 8)

6.Can take oral medicines

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

Exclusion Criteria

1.Subjects less than 17 years and above 70yrs old

2.Pregnancy and lactation

3.Patients with existing history of other inflammatory disease conditions

4.Patients currently taking anti-inflammatory drugs and

5.Immune-compromised subjects

6.Severe or complicated lung disease/infection

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

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.Change in the expression of inflammatory markers (IL-6, TNF-Î±, IFNÎ³, MIP1Î±, MIP1Î², MCP1, IP-10, IL-1Î²) using RT-PCR analysis in ARI patients from baseline to end of studyTimepoint: Day 0, day 3, day 5 and day 10

Secondary Outcome Measures

Name	Time	Method
1.Adverse events (AEs), frequency and severity from baseline to end of study <br/ ><br>2.Number of subjects who discontinue study due to adverse events at day 10 <br/ ><br>3.Changes in vital parameters and safety laboratory parameters (liver function test, renal function test, serum electrolyte) from baseline to day 10 <br/ ><br>Timepoint: Day 0 and Day 10