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

A randomized, controlled clinical study to compare efficacy of a polyherbal formulation (GP/PROD/2021/004) versus Standard Allopathic Formulation for relief of acute nonproductive cough and throat irritation - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/01/039180

Enrollment

Registered

2022-01-05

Start date

Unknown

Completion date

Unknown

Last updated

2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: polyherbal formulation (GP/PROD/2021/004): 10 ml thrice a day with water for 5 days Control Intervention1: Benadryl cough formula syrup: 10 ml thrice a day for 5 days

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
1. Changes in day and night frequencies of cough from baseline to end of treatment period on a 6-point scale 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

Measure	Time frame
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 3. Measure of drowsiness on a 2 point scale 4. Recurrence of cough after stoppage of medication.Timepoint: Baseline Day, Day 1, Day 2, Day 3, Day 4, Day 5, and Day 15	—

Measure

Time frame

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 3. Measure of drowsiness on a 2 point scale 4. Recurrence of cough after stoppage of medication.Timepoint: Baseline Day, Day 1, Day 2, Day 3, Day 4, Day 5, and Day 15

—

Countries

India

Contacts

Public ContactMr Chetan savaliya

Gplife Healthcare Pvt Ltd

gplifehealthcare@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026