UMIN-CTR Clinical Trial

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