UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041317 |
|---|---|
| Receipt number | R000046823 |
| Scientific Title | The study of oral treatment japanese treditional medicine Hainosankyuto for infectios epidermal cyst(infectious atheroma) |
| Date of disclosure of the study information | 2020/08/05 |
| Last modified on | 2020/08/05 00:30:14 |
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Basic information
Public title
The study of japanese traditonal medicine Kampo treatment for atheroma
Acronym
oral treatment of japanese traditional medicine for atheroma
Scientific Title
The study of oral treatment japanese treditional medicine Hainosankyuto for infectios epidermal cyst(infectious atheroma)
Scientific Title:Acronym
The study of Hainosankuto for infectious epidermal cyst
Region
| Japan |
Condition
Condition
infectious epidermal cyst
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Epidermal cyst sometimes causes severe bacterial infection and need incisional drainage under local anesthesia. We reviewed the short-term outcome of the severe infectious epidermal cyst(IEC) patients with the Japanese traditional medicine, Hainosankyuto, instead of surgical drainage.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The elimination of inflammatory symptom and no recurrence for a year defined short term cure and comparisons were made in cure rate and the internal use period, depending on gender, age, affected area, premedication antibiotics, and complication immunosuppressive disease.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with severely infected epidermal cysts who visited the clinic from January 1, 2013 to December 31, 2018 and need surgical drainage but wish to receive Chinese medicine due to frequent visits
Key exclusion criteria
1. Patients who do not understand the contents of informed consent
2. Patients who have difficulty taking oral medicine for physical reasons
3. Patients who have difficulty taking oral medicine due to mental reasons and mental illness
4. Patients with severe liver or renal damage
5. Patients who have been allergic to this drug
6. Patients who did not obtain the patient's consent
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | akiyo |
| Middle name | |
| Last name | gushi |
Organization
Gushi dermatology clinic
Division name
dermatology
Zip code
8950075
Address
45-3 Higashiohsyoji, Satsumasendai city, Kagoshima
TEL
0996229412
ruru0601@me.com
Public contact
Name of contact person
| 1st name | akiyo |
| Middle name | |
| Last name | gushi |
Organization
Gushi dermatology clinic
Division name
dermatology
Zip code
8950075
Address
45-3 Higashiohsyoji, Satsumasendai city, Kagoshima
TEL
0996229412
Homepage URL
ruru0601@me.com
Sponsor or person
Institute
Gushi dermatology clinic
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
Kagoshima University Clinical Research Ethics Committee
Address
8-35-1 Sakuragaoka , Kagoshima City, Kagoshima
Tel
0992756624
crmc@m2.kufm.kagoshima-u.ac.jp
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
医療法人具志ひふ科クリニック（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 05 | 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
130
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
| 2020 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 07 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 07 | Month | 30 | Day |
Other
Other related information
observational study
Management information
Registered date
| 2020 | Year | 08 | Month | 05 | Day |
Last modified on
| 2020 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046823
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
