UMIN-CTR Clinical Trial

Basic information
Public title	effect of administered astragalus radix for the purpose of glycation improvement
Acronym	effect of administered astragalus radix for the purpose of glycation improvement
Scientific Title	effect of administered astragalus radix for the purpose of glycation improvement
Scientific Title:Acronym	effect of administered astragalus radix for the purpose of glycation improvement
Region	Japan

Condition
Condition	adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate cases in which Ougi was administered for the purpose of glycation therapy, and to comprehensively examine the validity of the effect on glycation therapy and new findings.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skin autofluorescence (SAF), which can evaluate advanced glycation end products non-invasively, is used to evaluate glycation, and Ogi powder is administered to patients with high SAF values to evaluate the therapeutic effect.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Skin autofluorescence (SAF) was measured at the first visit and at 6 months.
Interventions/Control_2	Patients with higher than normal skin autofluorescence (SAF) were included in the treatment group. In the treatment group, the administration period of powdered Ougi was 6 months, and the dose was 6 g / day.
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	Male and Female
Key inclusion criteria	Selection criteria Patients over 20 years old at the time of consent Setting basis 1. For those who can show the free will of patients and their families with sufficient understanding 2. Set for accurate effectiveness assessment
Key exclusion criteria	Exclusion criteria Under 120 years old 2 Patients who had difficulty continuing oral administration 3 Patients who had difficulty in continuing medical examinations 4 Patients who could not follow the blood test 5 Patients with a history of allergies to legumes because legumes are legumes
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Shigeo Middle name Last name Aoyama
Organization	Medical Corporation Seiyukai
Division name	Aoyama Clinic
Zip code	460-0008
Address	3-7-13 Sakae, Naka-ku, Nagoya Cosmo Sakae Building 3F / 6F
TEL	0522536220
Email	aoyama.kampo@gmail.com

Public contact
Name of contact person	1st name Shigeo Middle name Last name Aoyama
Organization	Medical Corporation Seiyukai
Division name	Aoyama Clinic
Zip code	460-0008
Address	3-7-13 Sakae, Naka-ku, Nagoya Cosmo Sakae Building 3F / 6F
TEL	0522536220
Homepage URL
Email	aoyama.kampo@gmail.com

Sponsor
Institute	Aoyama Clinic, Medical Corporation Seiyukai
Institute
Department

Funding Source
Organization	Aoyama Clinic, Medical Corporation Seiyukai
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	oyama Clinic, Medical Corporation Seiyukai
Address	3-7-13 Sakae, Naka-ku, Nagoya Cosmo Sakae Building 3F / 6F
Tel	0522536220
Email	aoyama.kampo@gmail.com

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	2021 Year 09 Month 01 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	Open public recruiting
Date of protocol fixation	2019 Year 04 Month 01 Day
Date of IRB	2021 Year 02 Month 03 Day
Anticipated trial start date	2019 Year 04 Month 01 Day
Last follow-up date	2022 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	2021 Year 09 Month 01 Day
Last modified on	2021 Year 09 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051718