drugset / Trial / NCT06907355

CHAO Tos: Codeina, HederA Helix, LevOdropropizina Para la TOS

NCT06907355

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Upper respiratory tract infections affect millions globally, with cough being one of the most bothersome symptoms. While various treatments exist, their comparative effectiveness remains unclear. This study aims to evaluate and compare three commonly used treatments for acute cough in adults with upper respiratory tract infections: Levodropropizine, Codeine (with Pseudoephedrine and Chlorphenamine), and Ivy Leaf (Hedera Helix Extract). Investigators will conduct a double-blind, parallel-group randomized clinical trial with 184 adults aged 18-65 with acute upper respiratory tract infection and moderate to severe cough. Participants will be randomized to receive Levodropropizine, Codeine + Pseudoephedrine + Chlorphenamine, Ivy Leaf, or Placebo three times a day for 4 days. The primary outcome is cough severity at 48 hours, measured by a cough numerical rating scale. Secondary outcomes include cough severity and duration at 4- and 10-days. This trial will provide high-quality evidence comparing the efficacy of three widely used antitussive medications in primary care settings. The results could help establish evidence-based guidelines for treating acute cough in upper respiratory infections.

Timeline

Start
2025-05-13
Primary completion
2025-11-22
Completion
2025-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Codeine Small molecule 20 mg
Subject Hedera Helix Extract Unknown 70 mg
Subject Levodropropizine Small molecule 60 mg
Background Chlorphenamine Unknown 1 mg
Background Pseudoephedrine Small molecule 15 mg