UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016009 |
|---|---|
| Receipt number | R000018605 |
| Scientific Title | The study of the efficiency of Keishibukuryogankayokuinin on acne vulgaris. |
| Date of disclosure of the study information | 2014/12/19 |
| Last modified on | 2016/11/01 11:46:11 |
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Basic information
Public title
The study of the efficiency of
Keishibukuryogankayokuinin on acne
vulgaris.
Acronym
The study of the efficiency of
Keishibukuryogankayokuinin on acne
vulgaris.
Scientific Title
The study of the efficiency of
Keishibukuryogankayokuinin on acne
vulgaris.
Scientific Title:Acronym
The study of the efficiency of
Keishibukuryogankayokuinin on acne
vulgaris.
Region
| Japan |
Condition
Condition
Acne vulgaris
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficiency of Keishibukuryogankayokuinin in acne patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The decrement of inflammatory of acne lesions
The decrement of non-inflammatory of acne lesions
Patients QOL(SKINDEX-16,Syndromes presenting indefinite complaints)
Patients satisfaction(Visual analog scale)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The treatment with medicine for external use with Oral Administration of keishibukuryogankayokuinin(2.5g t.i.d before meals)for 12 weeks.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1)Patients who have inflammatory of acne lesions more than 6 counts on one side of their faces.
2)Patients for whom oral administration was possible.
3)Patients who agreed with their written informed consent
Key exclusion criteria
1)Patients with serious complications (liver,kidney,heart,blood,or metabolic disorders)
2)Steroid acne,Drug-induced acne,
Necrotizing acne, Occupational acne.
3)Patients who administrated steroid drugs on their whole body.
4)Women who are pregnant, might be pregnamt or lactating or planning a pregnancy.
5)Patients who received drugs prohibited for concomitant use within 1 week before the registration of this study.
6)Patients who participated in clinical trial within 1 month before the registration of this study.
7)Patients taking or planning chemical treatment or laser treatment in this study period.
8)Patients with history of hypersensitivity to traditional Japanese medicine.
9)Patients considered inappropriate by the study investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshitatsu Nogita |
Organization
Shinjuku Minamiguchi Dermatology Skin Clinic
Division name
Director
Zip code
Address
1-18-7 Nishishinjyuku Shinjyuku-ku Tokyo, Japan
TEL
03-3343-4103
nogita@hifuka.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshitatsu Nogita |
Organization
Shinjuku Minamiguchi Dermatology Skin Clinic
Division name
Director
Zip code
Address
1-18-7 Nishishinjyuku Shinjyuku-ku Tokyo, Japan
TEL
03-3343-4103
Homepage URL
nogita@hifuka.com
Sponsor or person
Institute
Shinjuku Minamiguchi Dermatology Skin Clinic
Institute
Department
Personal name
Funding Source
Organization
TSUMURA & CO.
Organization
Division
Category of Funding Organization
Profit 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
| 2014 | Year | 12 | Month | 19 | 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
| 2014 | Year | 11 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 19 | Day |
Last modified on
| 2016 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018605
| 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 |
