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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
196
Codeine 10mg/5ml + Pseudoephedrine 7.5mg/5ml + Chlorphenamine 0.5mg/5ml: 10ml three times per day during 4 days
Levodropropizine 30mg/5ml: 10ml three times per day during 4 days
Ivy Leaf (Hedera Helix Extract) 35 mg/5ml: 10ml three times per day during 4 days
Vitamins: 10ml three times per day during 4 days
Pontificia Universidad Catolica de Chile
Santiago, Chile
Change in cough severity
Change in cough severity measured by a cough numerical rating scale (0-10, higher scores mean higher cough severity)
Time frame: 48 hours
Change in cough severity
Change in cough severity measured with the cough numerical rating scale (0-10, higher scores mean higher cough severity)
Time frame: 4 days
Change in cough severity
Change in cough severity measured with the cough numerical rating scale (0-10, higher scores mean higher cough severity)
Time frame: 10 days
Change in cough severity and duration
Change in cough severity and duration measured with the Cough Severity Diary
Time frame: 48 hours
Change in cough severity and duration
Change in cough severity and duration measured with the Cough Severity Diary
Time frame: 4 days
Change in cough severity and duration
Change in cough severity and duration measured with the Cough Severity Diary
Time frame: 10 days
Treatment failure
Categorical outcome: Yes: Persisting with a score ≥6 in the cough numerical rating scale (0-10) No: Not having cough or persisting with a score \<6 in the cough numerical rating scale (0-10)
Time frame: 4 days
Treatment failure
Categorical outcome: Yes: Persisting with a score ≥6 in the cough numerical rating scale (0-10) No: Not having cough or persisting with a score \<6 in the cough numerical rating scale (0-10)
Time frame: 10 days
Treatment safety
Number of adverse events
Time frame: 48 hours
Treatment safety
Number of adverse events
Time frame: 4 days
Treatment safety
Number of adverse events
Time frame: 10 days
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