UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003610 |
|---|---|
| Receipt number | R000004299 |
| Scientific Title | Anti-aggravating effects of kakkonto, a Chinese herb, for common colds: a randomized controlled trial |
| Date of disclosure of the study information | 2010/05/17 |
| Last modified on | 2011/08/29 16:41:24 |
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Basic information
Public title
Anti-aggravating effects of kakkonto, a Chinese herb, for common colds: a randomized controlled trial
Acronym
The Great Cold Study III
Scientific Title
Anti-aggravating effects of kakkonto, a Chinese herb, for common colds: a randomized controlled trial
Scientific Title:Acronym
The Great Cold Study III
Region
| Japan |
Condition
Condition
common cold
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine whether a Chinese herb, kakkonto is effective for suppression of the progression of the symptoms and the acceleration of the recovery in the very early stage of the common cold in comparison with the western cold medicine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
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.
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Kakkonto three times a day before meal or 2 hours after meal for 4 days in principle.
Interventions/Control_2
The western cold medicine named "Pabron Gold A" produced by Taisho Pharmaceutical three times a day after meal for 4 days in principle.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key 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
Key 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
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kawamura |
Organization
Kyoto University School of Public Health
Division name
Department of Preventive Services
Zip code
Address
Yoshida Honmachi, Sakyo-ku Kyoto, 606-8501 JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto University School of Public Health
Division name
Department of Preventive Services
Zip code
Address
Yoshida Honmachi, Sakyo-ku Kyoto, 606-8501 JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Kyoto University School of Public Health
Department of Preventive Services
Institute
Department
Personal name
Funding Source
Organization
A Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports,. Science and Technology, 2010 (#22590650)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 13 | Day |
Last modified on
| 2011 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004299
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