UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041317
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email ruru0601@me.com

Sponsor
Institute Gushi dermatology clinic
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 Kagoshima University Clinical Research Ethics Committee
Address 8-35-1 Sakuragaoka , Kagoshima City, Kagoshima
Tel 0992756624
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046823

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.