Effect of Paracetamol on the Common Cold

Study Overview
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Brief Summary
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The aim of this study is to subjectively assess symptoms in subjects suffering from the common cold following a single dose of paracetamol hot drink compared to paracetamol tablet

Official Title
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To Assess the Subjective Effect of Two Paracetamol Preparations on the Feeling of Breathing in Subjects With the Common Cold.

Conditions
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Common Cold

Intervention / Treatment
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* Drug: Paracetamol hot drink
* Drug: Paracetamol tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptoms of the common cold of no more than 120 hours duration Self-rating congestion of at least moderate severity Suffering from at least four symptoms of common cold or flu

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paracetamol hot drink<br>Hot drink containing paracetamol | Drug: Paracetamol hot drink<br>* Hot drink containing paracetamol<br>|
| Active Comparator: Paracetamol tablets<br>Paracetamol tablets | Drug: Paracetamol tablets<br>* Paracetamol tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breathing Scores Post 15 Minutes | A mean breathing score was calculated at baseline, 30 seconds, 2, 5 and 15 minutes, derived from participant responses to questions relating to breathing i.e. my breathing feels easy, I feel airways are open, I feel a cooling sensation in my throat, I can feel the air flowing to my lungs easily, My nose feels less blocked and I feel my breathing is comfortable. The breathing scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered. | Baseline to 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breathing Score Post 60 Minutes | A mean breathing score was calculated at baseline, 30 seconds, 2, 5, 15 and 60 minutes, derived from participant responses to questions relating to breathing i.e. my breathing feels easy, I feel airways are open, I feel a cooling sensation in my throat, I can feel the air flowing to my lungs easily, My nose feels less blocked and I feel my breathing is comfortable. The breathing scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered. | Baseline to 60 minutes | 
| Cold Symptoms Score Post 15 Minutes | A mean Cold symptom score was calculated at baseline, 30 seconds, 2, 5 and 15 minutes from participant responses to questions relating to cold symptoms i.e. My head feels clear, I feel soothing in my throat and I feel my cough is being soothed. The cold symptom scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered. | Baseline to 15 minutes | 
| Cold Symptoms Score Post 60 Minutes | A mean Cold symptom score was calculated at baseline, 30 seconds, 2, 5, 15 and 60 minutes from participant responses to questions relating to cold symptoms i.e. My head feels clear, I feel soothing in my throat and I feel my cough is being soothed. The cold symptom scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered. | Baseline to 60 minutes | 
| Soothing Attribute Scores | Soothing attribute of test treatment was assessed by asking the question if the hot drink is soothing at baseline, 15 and 60 minutes. The response to the question was rated by participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. | Baseline to 15 and 60 minutes | 
| Overall Cold Symptoms Score | Overall cold symptom score was assessed by asking the question my cold symptoms are improved only post consuming the drink at baseline, 15 and 60 minutes . The response to the question was rated by participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. | Baseline to 15 and 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paracetamol, Common cold