Clinical Trial of herbal formulation (GP/PROD/2021/004) in acute cough and throat irritatio

Phase 2

Completed

• Conditions: Health Condition 1: J069- Acute upper respiratory infection,unspecified

• Registration Number: CTRI/2022/01/039180
• Lead Sponsor: Mr Kamlesh Thummar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-12-28
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

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

Inclusion Criteria

Patients with H/O acute nonproductive cough and throat irritation for less than 1week duration

Males and Females between 18-65 years age

Patients who in the opinion of the Investigator will be able to comply with the study requirements

Patients with a cough score of 0, 1 or 2 during day time

Patients willing and able to provide signed informed consent for any study related procedures.

Exclusion Criteria

Patients with H/O lower respiratory tract infections such as Pneumonia, Tuberculosis, Bronchitis, Whooping cough.

Patients with H/O Chronic Obstructive Pulmonary

Diseases/Asthma

Patients with H/O underlying lung pathology such as lung abscess, cystic fibrosis.

Patients with known hypersensitivity to ingredients of Investigational Products

Patients with clinical suspicion of any systemic bacterial infection.

Patients with H/O Myocardial Infarction (MI) within 4 weeks prior to enrollment

Patients with immediate life threatening diseases such as pre-existing cardiovascular, liver or neoplastic disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Changes in day and night frequencies of cough from baseline to end of treatment period on a 6-point scale <br/ ><br>2. Change in throat irritation from baseline to end of treatment period on a 5-point scaleTimepoint: Baseline Day, Day 1, Day 2, Day 3, Day 4, Day 5, and Day 15

Secondary Outcome Measures

Name	Time	Method
1.Time to relief from cough and throat irritation on 5 point scale for first morning dose over a treatment period of 5 days <br/ ><br>2.Duration of relief from symptoms on a 5 point scale for first morning dose over a treatment period of 5 days <br/ ><br>3. Measure of drowsiness on a 2 point scale <br/ ><br>4. Recurrence of cough after stoppage of medication.Timepoint: Baseline Day, Day 1, Day 2, Day 3, Day 4, Day 5, and Day 15