A Study to assess the Efficacy and Safety of Goviro Soft Gel Capsule as an adjuvant with Imunocin tablet and Standard of care in patients with Upper Respiratory Tract Infectio

Not Applicable

Completed

• Conditions: Health Condition 1: J00-J06- Acute upper respiratory infections

• Registration Number: CTRI/2021/08/035662
• Lead Sponsor: Gufic Biosciences Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-04-20
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 66

Inclusion Criteria

1.Male/female of �18 and �65 years of age

2.Patient who can and willing to provide written Informed Consent

3.Patient with at least 2 symptoms of URTI (Sneezing, Runny nose, nose block, sore throat, fever, fatigue) since last 48 hours

4.Patient who can take medicines orally

5.Female of childbearing potential must have a negative urine pregnancy test and be non-lactating at screening visit

6.Patient/ patientââ?¬•s legally acceptable representative understands and can comply with clinical trial protocol requirements

Exclusion Criteria

1.Patient Ã?â?? 18 or Ã?Æ? 65 years of age

2.Pregnant and/or nursing woman

3.Patient with clinical evidence of a lower respiratory tract infection, as determined by the Investigator at the time of screening

4.Patient with anticipated need for hospitalization or emergency room care within 24 hours of screening

5.Patient with any other clinically significant illness

6.Patient with cases/ instances of severe vomiting which would affect oral administration of medicine

7.Patient taking any medication or having an indication that might point to an increased risk, associated with study participation or study drug administration or may interfere with the interpretation of study results and in the judgment of the study personnel, would make the subject inappropriate for inclusion

8.Patient who has participated in another trial with an investigational drug within 3 months prior to this trial.

9.Patient with history of malignancy, Cardiovascular Disease (CVD), Stroke, etc.

10.Patient with moderate to severe COVID 19 symptoms

11.Patient with any other condition, which as per the investigator would jeopardize the outcome of the trial

12.Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in WURSS-21 score from Screening Visit/ Enrolment Visit/ Baseline Visit (Day 0) to End of treatment (Day 7). <br/ ><br> <br/ ><br>Change in Cold symptom scale score from Screening Visit/ Enrolment Visit/ Baseline Visit (Day 0) to End of treatment (Day 7). <br/ ><br>Timepoint: Mean change in WURSS-21 score from Screening Visit/ Enrolment Visit/ Baseline Visit (Day 0) to End of treatment (Day 7). <br/ ><br> <br/ ><br>Change in Cold symptom scale score from Screening Visit/ Enrolment Visit/ Baseline Visit (Day 0) to End of treatment (Day 7). <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Reduction in number of doses of Antibiotics from Baseline to End of treatment. <br/ ><br>Change in Complete Blood Count (CBC), Erythrocyte sedimentation rate (ESR), C- Reactive Protein (CRP) from Screening Visit/ Enrolment Visit/ Baseline Visit to End of treatment <br/ ><br>Change in following parameters form Screening Visit/ Enrolment Visit/ Baseline Visit and End of treatment <br/ ><br>BUN <br/ ><br>Serum creatinine <br/ ><br>Liver Function Tests (LFT) Parameters <br/ ><br> <br/ ><br>Timepoint: Baseline (Day 0) to End of treatment (Day 7).