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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Change in cough severity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have between 18 and 65 years of age.
- •Have an URTI with Jackson Score ≥6 points.
- •Have moderate or severe cough assessed by having a score ≥2 points in the cough domain of the Jackson Score and ≥60mm on the cough visual analogue scale (VAS).
- •Have initiated cough within 5 days of enrollment.
- •Be capable of understanding and complying with study procedures.
- •Sign a written informed consent.
排除标准
- •Physician considers that potential participant needs or might need to use antibiotics at the screening visit (e.g., suspected bacterial otitis, bacterial tonsilitis, bacterial sinusitis, bacterial bronchitis, or bacterial pneumonia) or suspected need for antibiotics during patient follow-up.
- •Individuals with pre-existing respiratory conditions, including asthma, chronic obstructive pulmonary disease (COPD), or any chronic lower respiratory tract disease.
- •Uncontrolled cardiovascular condition (hypertension, diabetes, etc.)
- •Contraindications to use Levodropropizine, Codeine, Pseudoephedrine, Chlorphenamine, or Ivy Leaf (Hedera Helix Extract), including Fructose Intolerance, Bronchorrhea, Kartagener Syndrome, Ciliary Dyskinesia, Respiratory Failure, Bronchial Obstructive Syndrome, severe Hypertension, Peptic Ulcer, using Monoamine Oxidase Inhibitors (MAOIs), CYP2D6 ultra-fast metabolizers.
- •Pregnancy, suspected pregnancy, desired pregnancy, or breastfeeding.
- •Contraindications to the study medications will also result in exclusion, including known or suspected allergies to Levodropropizine, Codeine, Pseudoephedrine, Chlorphenamine, or Hedera Helix Extract.
- •Known adverse reactions to Levodropropizine, Codeine, Pseudoephedrine, Chlorphenamine, or Hedera Helix Extract.
- •Participants currently using medications that could interfere with study outcomes, such as other cough suppressants, inhalers, or systemic corticosteroids.
- •Researcher considers participant might not comply with study procedures.
研究组 & 干预措施
Levodropropizine
Levodropropizine 30mg/5ml: 10ml three times per day during 4 days
干预措施: Levodropropizine (Drug)
Codeine
Codeine 10mg/5ml + Pseudoephedrine 7.5mg/5ml + Chlorphenamine 0.5mg/5ml: 10ml three times per day during 4 days
干预措施: Codeine (Drug)
Ivy Leaf (Hedera Helix Extract)
Ivy Leaf (Hedera Helix Extract) 35 mg/5ml: 10ml three times per day during 4 days
干预措施: Ivy Leaves Cough Liquid (Drug)
Placebo
Vitamins: 10ml three times per day during 4 days
干预措施: Placebo (Drug)
结局指标
主要结局
Change in cough severity
时间窗: 48 hours
Change in cough severity measured by a cough numerical rating scale (0-10, higher scores mean higher cough severity)
次要结局
- Change in cough severity(10 days)
- Change in cough severity and duration(10 days)
- Treatment failure(10 days)
- Treatment safety(10 days)
研究者
Diego Garcia Huidobro
Associate Professor
Pontificia Universidad Catolica de Chile