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

NCT06907355 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2025-12-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • UC CHRISTUS

    collaborator UNKNOWN

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Chile

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06907355 on ClinicalTrials.gov