UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050727 |
|---|---|
| Receipt number | R000057794 |
| Scientific Title | Exploratory study on effects of Tochu (Eucommia ulmoides) leaf extract components on vascular and inflammatory indices in chronic kidney disease. |
| Date of disclosure of the study information | 2023/03/30 |
| Last modified on | 2024/09/29 09:33:21 |
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Basic information
Public title
Exploratory study on effects of Tochu (Eucommia ulmoides) leaf extract components on vascular and inflammatory indices in chronic kidney disease.
Acronym
Exploratory study on effects of Tochu (Eucommia ulmoides) leaf extract components on vascular and inflammatory indices in chronic kidney disease.
Scientific Title
Exploratory study on effects of Tochu (Eucommia ulmoides) leaf extract components on vascular and inflammatory indices in chronic kidney disease.
Scientific Title:Acronym
Exploratory study on effects of Tochu (Eucommia ulmoides) leaf extract components on vascular and inflammatory indices in chronic kidney disease.
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore effects of oral supplement (product name: Tochu gen Gx) containing Tochu tea extracts, taken at recommended dose for 10 (8-12) weeks, on vascular and inflammatory indices in chronic kidney disease (CKD) patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Circulating endothelial progenitor cell numbers by flowcytometry at the start and at the end of Tochu tea supplement administration for 10 (8-12) weeks.
Key secondary outcomes
Circulating monocyte subset ratios (flowcytometry) , serum adiponectin, high-sensetivity CRP, oxidized LDL, oxidative stress (ROM) and anti-oxidative (BAP) indices, at the start and at the end of Tochu tea supplement administration for 10 (8-12) weeks.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Tochu tea supplement (product name: Tochu gen GX) at recommended dose of 9 tablets per day is administered for 10 (8-12) weeks. Blood samples at the start and at the end of administration are used for outcome measurements including those by flowcytometry.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Chronic kidney disease patients at stages G1 to G3a (eGFR >45 mL/min/1.73m2) and/or proteinuria of more than 0.15g/gCr (or albuminuria of more than 30mg/gCr).
2. Males and females 20 years or more of age.
3. Those from whom consent to study participation was obtained with use of informed conset document.
Key exclusion criteria
1. Those with malignant disease.
2. Those with dementia or impaired cognitive function.
3. Those with serious comorbid conditions who were judged not suited for participation by physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Satonaka |
Organization
Dokkyo Medical University
Division name
Department of Nephrology and Hypertension
Zip code
321-0293
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi-ken, JAPAN
TEL
0282-86-1111
satonakah@nifty.com
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Satonaka |
Organization
Dokkyo Medical University
Division name
Department of Nephrology and Hypertension
Zip code
321-0293
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi-ken, JAPAN
TEL
0282-86-1111
Homepage URL
satonakah@nifty.com
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Japanaese Society of Eucommia
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
Clinical Research Review Committee, Dokkyo Medical University Hospital
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi-ken, JAPAN
Tel
+81-282-86-1111
r-kenkyu@dokkyomed.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 08 | 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
| 2023 | Year | 03 | Month | 30 | Day |
Last modified on
| 2024 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057794
