UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045337 |
|---|---|
| Receipt number | R000051718 |
| Scientific Title | effect of administered astragalus radix for the purpose of glycation improvement |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2021/09/01 13:34:46 |
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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
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
aoyama.kampo@gmail.com
Sponsor or person
Institute
Aoyama Clinic, Medical Corporation Seiyukai
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051718
