Clinical Trial to Evaluate the Safety and Efficacy of Theobromine Capsule as an Antitussive in Acute Cougher

Study Overview
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Brief Summary
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The aim of this clinical trial is to evaluate the antitussive effect of Theobromine capsule 300mg in patients with acute bronchitis.

Detailed Description
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This study is double blinded, randomized, parallel designed, phase III clinical trial to evaluate the efficacy and safety of Theobromine capsule 300mg versus Levodropropizine syrup in patients with acute bronchitis.

Official Title
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Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of Theobromine Capsule 300mg as an Antitussive Agent in Acute Cough Patients.

Conditions
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Acute Bronchitis

Intervention / Treatment
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* Drug: Theobromine 300mg
* Drug: Levodropropizine 10mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who decided to participate in this clinical trial at his(her) own will and agreed in written letter of consent. Adult aged over 18 Patient who has cough symptom caused by acute bronchitis Patient who go to see the doctor for severe cough at his(her) own will DCS score at screening vist sould be over 3. For fertile woman, HCG test at screening visit shloud be negative. patient who will continue to cough more than 1 week.(by physician's judgment) Exclusion Criteria: Patient who is accompanied by the seriously abnormal symptom in respiratory system, such as Acute infectious Pulmonary Disease, Tuberculosis, asthma. Chronic bronchitis including bronchial obstruction Patient who has clinical history of sensitivity to Xanthine drug. Patient who has Peptic Ulcer Patient whose liver or kidney function is seriously abnormal: Including the cases of sGOT, sGPT, bilirubin and blood creatinine value exceeding twice of their upper normal limit. Patient whose heart function is abnormal: including the case of showing abnormal EKG test value that is clinically significant. patient who has convulsion or alcoholism. Patient who has experience to have participated in other clinical trial within two months before starting the trial. Pregnant woman, lactating woman. Patient who thought to be cured within 3 days without any medicine.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Theobromine<br>Theobromine capsule 300mg | Drug: Theobromine 300mg<br>* Capsule, b.i.d.<br>|
| Active Comparator: levodropropizine<br>levodropropizine syrup | Drug: Levodropropizine 10mg<br>* Syrup, t.i.d.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cough remission rate | cough remission : no cough or 1 short cough in day time | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cough recovery rate |  | 1 day, 2 days, within 3days | 
| difference of DCS score between screening and closing visit. |  | 3 days | 
| required time for cough remission |  | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Theobromine, cough, acute bronchitis