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| Name | Class |
|---|---|
| UC CHRISTUS | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levodropropizine | Experimental | Levodropropizine 30mg/5ml: 10ml three times per day during 4 days |
|
| Codeine | Experimental | Codeine 10mg/5ml + Pseudoephedrine 7.5mg/5ml + Chlorphenamine 0.5mg/5ml: 10ml three times per day during 4 days |
|
| Ivy Leaf (Hedera Helix Extract) | Experimental | Ivy Leaf (Hedera Helix Extract) 35 mg/5ml: 10ml three times per day during 4 days |
|
| Placebo | Placebo Comparator | Vitamins: 10ml three times per day during 4 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Codeine | Drug | Codeine 10mg/5ml + Pseudoephedrine 7.5mg/5ml + Chlorphenamine 0.5mg/5ml: 10ml three times per day during 4 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in cough severity | Change in cough severity measured by a cough numerical rating scale (0-10, higher scores mean higher cough severity) | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cough severity | Change in cough severity measured with the cough numerical rating scale (0-10, higher scores mean higher cough severity) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pontificia Universidad Catolica de Chile | Santiago | Chile |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D003371 | Cough |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
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| ID | Term |
|---|---|
| D003061 | Codeine |
| C035916 | dipropizine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Levodropropizine | Drug | Levodropropizine 30mg/5ml: 10ml three times per day during 4 days |
|
| Ivy Leaves Cough Liquid | Drug | Ivy Leaf (Hedera Helix Extract) 35 mg/5ml: 10ml three times per day during 4 days |
|
| Placebo | Drug | Vitamins: 10ml three times per day during 4 days |
|
| 10 days |
| Change in cough severity and duration | Change in cough severity and duration measured with the Cough Severity Diary | 48 hours |
| Change in cough severity and duration | Change in cough severity and duration measured with the Cough Severity Diary | 4 days |
| Change in cough severity and duration | Change in cough severity and duration measured with the Cough Severity Diary | 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) | 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) | 10 days |
| Treatment safety | Number of adverse events | 48 hours |
| Treatment safety | Number of adverse events | 4 days |
| Treatment safety | Number of adverse events | 10 days |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |