UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012835 |
|---|---|
| Receipt number | R000014994 |
| Scientific Title | Investigation of the efficacy of rikkosan on oral pain |
| Date of disclosure of the study information | 2014/01/13 |
| Last modified on | 2014/01/13 11:39:18 |
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Basic information
Public title
Investigation of the efficacy of rikkosan on oral pain
Acronym
Investigation of the efficacy of rikkosan on oral pain
Scientific Title
Investigation of the efficacy of rikkosan on oral pain
Scientific Title:Acronym
Investigation of the efficacy of rikkosan on oral pain
Region
| Japan |
Condition
Condition
Patient with oral pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investige the efficacy of rikkosan on the oral pain using the pain index and food intake
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain index or pain score
Key secondary outcomes
Food intake
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of rikkosan (7.5g/day t.i.d.) with honey(15g/day t.i.d.) before meals for 3 days.
Interventions/Control_2
Oral administration of honey(15g/day t.i.d.) before meals for 3 days.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient with oral pain
Key exclusion criteria
a) Patients being treated for following advanced conditions; atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, and other chronic disease
b) Patients who are allergic to medicines, or foods related to the test material of this trial
c) Pregnant women, lactating women, or women who want to get pregnant during the trial period
d) Patients who are enrolled in the other clinical trials before the agreement for the participation to this trial
e) Patients who are judged not suitable to participate in this trial by physician.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryoko Kawahara |
Organization
Nissay Hospital
Division name
Anesthesiology and Palliative care
Zip code
Address
6-3-8, Itachibori, Nishi-ku, Osaka, 550-0012
TEL
06-6543-3581
kawahara.ryoko@nissay-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoko Kawahara |
Organization
Nissay Hospital
Division name
Anesthesiology and Palliative care
Zip code
Address
6-3-8, Itachibori, Nishi-ku, Osaka, 550-0012
TEL
06-6543-3581
Homepage URL
kawahara.ryoko@nissay-hp.or.jp
Sponsor or person
Institute
Nissay Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 01 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 13 | Day |
Last modified on
| 2014 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014994
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
