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

Phase 2/3

Completed

Conditions: Acute upper respiratory infection,unspecified. Ayurveda Condition: KASAH,

Registration Number: CTRI/2022/01/039180

Lead Sponsor: Mr Kamlesh Thummar

Brief Summary: The clinical study is planned to evaluate clinical effectiveness of a polyherbal formulation (GP/PROD/2021/004) versus StandardAllopathic Formulation for relief of acute nonproductive cough and throatirritation.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

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	Baseline Day, Day 1, Day 2, Day 3, Day 4, Day 5, and Day 15
2. Change in throat irritation from baseline to end of treatment period on a 5-point scale	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	2.Duration of relief from symptoms on a 5 point scale for first morning dose over a treatment period of 5 days

Trial Locations

Locations (2): Atharv multispecialty Research center
🇮🇳
Pune, MAHARASHTRA, India
Lokmanya Medical Research Centre
🇮🇳
Pune, MAHARASHTRA, India
Atharv multispecialty Research center
🇮🇳Pune, MAHARASHTRA, India
Dr Tanuja Panchabhai
Principal investigator
9421885129
drtanuja.panchabhai@gmail.com