Overview
Clinical Trial to Evaluate the Safety and Efficacy of "Theobromine Capsule" as an Antitussive in Acute Cougher
Status:
Completed
Completed
Trial end date:
2011-05-01
2011-05-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The aim of this clinical trial is to evaluate the antitussive effect of "Theobromine capsule 300mg" in patients with acute bronchitis.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Ahn-Gook Pharmaceuticals Co.,LtdTreatments:
Antitussive Agents
Chlorpheniramine, phenylpropanolamine drug combination
Dipropizine
Guaifenesin
Phenylpropanolamine
Theobromine
Criteria
Inclusion Criteria:1. Patient who decided to participate in this clinical trial at his(her) own will and
agreed in written letter of consent.
2. Adult aged over 18
3. Patient who has cough symptom caused by acute bronchitis
4. Patient who go to see the doctor for severe cough at his(her) own will
5. DCS score at screening vist sould be over 3.
6. 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:
1. Patient who is accompanied by the seriously abnormal symptom in respiratory system,
such as Acute infectious Pulmonary Disease, Tuberculosis, asthma.
2. Chronic bronchitis including bronchial obstruction
3. Patient who has clinical history of sensitivity to Xanthine drug.
4. Patient who has Peptic Ulcer
5. 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.
6. Patient whose heart function is abnormal: including the case of showing abnormal EKG
test value that is clinically significant.
7. patient who has convulsion or alcoholism.
8. Patient who has experience to have participated in other clinical trial within two
months before starting the trial.
9. Pregnant woman, lactating woman.
10. Patient who thought to be cured within 3 days without any medicine.