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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012835
Receipt No. 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

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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
Email 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
Email kawahara.ryoko@nissay-hp.or.jp

Sponsor
Institute Nissay Hospital
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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