A Clinical Trial to compare efficacy of a polyherbal ayurvedic formulation ?Dabur Honitus? versus ?Standard Allopathic Formulation? for symptomatic relief of acute non productive cough and throat irritation

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2011
INTERVENTION: Intervention1: Honitus Syrup: Ayurvedic Formulation: Dose, duration and frequency of the same are 10 ml ( 2 teaspoonful) orally 4 times a day for a period of 3 days Control Intervention1: Benadryl Cough Formula Syrup: Benadryl Cough Formula Syrup(Dose, duration and frequency of the same are 10 ml ( 2 teaspoonful) orally 4 times a day for a period of 3 days) CONDITION: Patients with acute non productive cough and throat irritation for less than 1 week duration and age range is 18 ‐ 65 years PRIMARY OUTCOME: Changes in day and night frequencies of cough from baseline on a 6 point scale in ; patients with acute non‐ productive cough receiving therapy over a period of 3 ; days and Change in throat irritation on a 5 point scale from 0‐4 over a treatment period of ; 3 days‐‐‐‐‐‐Timepoint: Changes in day and night frequencies of cough from baseline on a 6 point scale in ; patients with acute non‐ productive cough receiving therapy over a period of 3 ; days and Change in throat irritation on a 5 point scale from 0‐4 over a treatment period of ; 3 days SECONDARY OUTCOME: Time to relief from cough and throat irritation on a 5 point scale for first morning dose over a treatment period of 3 days, Duration of relief from symptoms on a 5 point scale for first morning dose over a treatment period of 3 days, Measure of drowsiness on a 2 point scale and Physicianâ??s global assessment of efficacy on a 5 point scale‐‐‐‐‐‐Timepoint: Time to relief from cough and throat irritation on a 5 point scale for first morning dose over a treatment period of 3 days, Duration of relief from symptoms on a 5 point scale for first morning dose over a treatment period of 3 days, Measure of drowsiness on a 2 point scale and Physicianâ??s global assessment of efficacy on a 5 point scale INCLUSION CRITERIA: 1. Patients with H/O acute non productive cough and throat irritation for less than 1 week duration 2. Males and Females between 18‐65 years age. 3. Patients who in the opinion of the Investigator will be able to comply with the study requirements. 4. Patients with a cough score of 0, 1 or 2 during day time 5. Patients willing and able to provide signed informed consent form prior to any study related procedures.
Epistemonikos ID: 56d8cbda60a42063d201b6ac16652870312426d2
First added on: Aug 22, 2024