NCT06907355

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

A Double-Blind Randomized Clinical Trial Comparing Levodropropizine, Codeine, Ivy Leaf (Hedera Helix Extract), and Placebo for the Treatment of Acute Cough in Adults With Upper Respiratory Tract Infections in Primary Care

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Pontificia Universidad Catolica de Chile · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Upper Resp Tract Infection

Interventions

Type	Name	Description
DRUG	Codeine	Codeine 10mg/5ml + Pseudoephedrine 7.5mg/5ml + Chlorphenamine 0.5mg/5ml: 10ml three times per day during 4 days
DRUG	Levodropropizine	Levodropropizine 30mg/5ml: 10ml three times per day during 4 days
DRUG	Ivy Leaves Cough Liquid	Ivy Leaf (Hedera Helix Extract) 35 mg/5ml: 10ml three times per day during 4 days
DRUG	Placebo	Vitamins: 10ml three times per day during 4 days

Timeline

• Start date: 2025-05-13
• Primary completion: 2025-11-22
• Completion: 2025-12-01
• First posted: 2025-04-02
• Last updated: 2025-12-03

Locations

1 site across 1 country: Chile