common cold
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients who satisfy all of the following criteria will be participated in this study. 1. Discomfort, pain, or scratchiness in the throat 2. The symptoms began on the day or the previous day of the visit. 3. Chillness 4. Without sweating 5. Catching a cold once at least within the past 3 years
Exclusion criteria
Exclusion criteria: Patients who meet one of the following criteria cannot be participated in this study. 1. Moderate or severe symptoms on the day or the previous day of the visit 2. A body temperature of 37.5 degree Celsius or higher 3. Diagnosed as or highly suspicious of pneumonia, tonsillitis, or influenza and measles virus infections 4. Having taken medicines including over-the-counter remedies for the cold 5. A weak constitution 6. Digestive symptoms 7. Dysuria 8. Edema in the face or legs 9. Patients who are prone to gastrointestinal disorders 10. Pregnant women 11. Breastfeeding women 12. Allergic constitution 13. Having had an allergic reaction to any medicine 14. Thyroid dysfunction 15. Diabetes mellitus 16. Heart disease 17. Serious hypertension (above 180/110 mmHg) 18. Liver disease 19. Gastroduodenal ulcer 20. Glaucoma 21. Bronchial asthma 22. Kidney disease 23. A blood disease 24. A drug addiction 25. Heavy alcohol drinkers 26. Any other serious diseases 27. Patients who are planning to attend an athletic meeting (according to the doping problem) 28. Patients who are judged to be inappropriate for this study by doctors or nurses 29. Patients who have already participated in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is whether one of the 3 symptoms, the nasal, pharyngeal, and tracheal symptoms, will be moderate or severe in the self-reporting questionnaire for 2 days or more during the first 5 days from the beginning of the treatment. ("Moderate" is defined as when a patient always feels discomfort and "severe" is defined as when a patient experiences difficulties in daily life.) If some individual cold symptoms were evaluated as "moderate" before the treatment, we will check up on whether they will be severe for more than two days during the first five days from the beginning of the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The ratio of the participants who have a moderate or severe symptom on the 5th day after taking the test drugs. 2. The sum of the symptom scores during the 5 days. 3. The ratio of the participants who have a severe symptom during the 5 days. 4. The ratio of the participants who have a moderate or severe nasal, pharyngeal, or tracheal symptom for 2 days or more during the 7 days. If some individual cold symptoms were evaluated as "moderate" before the treatment, we will check up on whether they will be severe for more than two days during seven days after the treatment. | — |
Countries
Japan