UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of two components of herbal medicine on kidney function
Title of the study (Brief title)	Effects of two components of herbal medicine on kidney function
Region	Japan

Condition
Condition	Kidney disease
Classification by specialty	Medicine in general Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Improvement of the renal function
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement effect of the renal
Key secondary outcomes	Improvement effect of carotid artery IMT Improvement effect of CAVI

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Pseudo-randomization

Intervention
No. of arms	7
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	astragali radix 1 day 6.0g, 1 year
Interventions/Control_2	angelicae radix 1 day 1.5g, 1 year
Interventions/Control_3	ginseng radix 1 day 1.5g, 1 year
Interventions/Control_4	rhubarb 1 day 0.5~1.5g, 1 year
Interventions/Control_5	glycyrrhiza 1 day 2.0g, 1 year
Interventions/Control_6	carotid artery IMT
Interventions/Control_7	CAVI
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	eGFR<60
Key exclusion criteria	eGFR>=60
Target sample size	50

Research contact person
Name of lead principal investigator	Akira Fushimi
Organization	Fushimi clinic
Division name	Internal medicine
Address	5-4-16 Minamiku, izumida, Okayama city, Okayama, Japan
TEL	086-241-3480
Email	fusimi-i@po.harenet.ne.jp

Public contact
Name of contact person	Akira Fushimi
Organization	Fushimi clinic
Division name	Internal medicine
Address	5-4-16 Minamiku, Izumida, Okayama city, Okayama, Japan
TEL	086-241-3480
Homepage URL
Email	fusimi-i@po.harenet.ne.jp

Sponsor
Institute	Fushimi clinic
Institute
Department

Funding Source
Organization	Fushimi clinic
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2020 Year 12 Month 31 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2019 Year 01 Month 15 Day
Anticipated trial start date	2019 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2019 Year 01 Month 25 Day
Last modified on	2019 Year 02 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040583