Skip to content

Anti-aggravating effects of kakkonto, a Chinese herb, for common colds: a randomized controlled trial

Anti-aggravating effects of kakkonto, a Chinese herb, for common colds: a randomized controlled trial - The Great Cold Study III

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003610
Enrollment
300
Registered
2010-05-17
Start date
2010-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

common cold

Interventions

Kakkonto three times a day before meal or 2 hours after meal for 4 days in principle. The western cold medicine named &quot
Pabron Gold A&quot
produced by Taisho Pharmaceutical three times a day after meal for 4 days in principle.

Sponsors

Kyoto University School of Public Health Department of Preventive Services
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026