UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028858 |
|---|---|
| Receipt number | R000032938 |
| Scientific Title | A study to analyze antioxidant capacity of SEINETSUYAKU in Kampo using saliva |
| Date of disclosure of the study information | 2017/08/29 |
| Last modified on | 2020/02/29 10:29:00 |
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Basic information
Public title
A study to analyze antioxidant capacity of SEINETSUYAKU in Kampo using saliva
Acronym
A study to analyze antioxidant capacity of SEINETSUYAKU in Kampo using saliva
Scientific Title
A study to analyze antioxidant capacity of SEINETSUYAKU in Kampo using saliva
Scientific Title:Acronym
A study to analyze antioxidant capacity of SEINETSUYAKU in Kampo using saliva
Region
| Japan |
Condition
Condition
High value of oxidative stress
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the antioxidant capacity of Kampo medicine when ingested into the living body, analyzing the antioxidant capacity of saliva after rinsing the mouth with Kampo medicine decoctions such as SEINETSUYAKU(heat-clearing medicine).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oxidation-reduction Potential(ORP)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
Test agent1: Decoction of Ouren 3g.Dosage regimen: Collect saliva after rinsing the mouth for 1 minute with decoction(40ml). (single dose).In addition, 34 kinds of herbal medicine and 35 mixtures of herbal medicine are used as test agents.*26 kinds of herbal medicine(3g each):Ougon,Oubaku,Sanshishi,Sekkou,Chimo,Daiou,Saiko,Jiou,Kinginka,Koubei,Kanzou,Ninjin,Ryokucha.Kankyo,Shokyo,Taiso,Hange,Rengyo,Inchinko,Ryutan,Hakka,Soyo,Tanzin,Shyakuyaku,Botanpi,Boui.*8 kinds of herbal medicine:Ouren1.5g,Ouren1g,Ougon2.5g,Hange5g,Kankyo2.5g,Kanzo2.5g,Taiso2.5g,Ninjin2.5g.*15 mixtures of herbal medicine(gross weight of mixture: 3g each):Mixture of Ouren,Ougon,Oubaku,Sanshishi.Mixture of Ouren,Ougon,Oubaku.Mixture of Ouren,Ougon,Sanshishi.Mixture of Ouren,Oubaku,Sanshishi.Mixture of Ougon,Oubaku,Sanshishi.Mixture of Sekkou,Chimo,Koubei,Kanzou,Ninjin.Mixture of Sekkou,Chimo.Mixture of Sekkou decoction and Chimo decoction.Mixture of Ouren,Ougon.Mixture of Ouren,Oubaku.Mixture of Ouren, Sanshishi.Mixture of Ougon,Oubaku.Mixture of Ougon,,Sanshishi.Mixture of Oubaku,Sanshishi.Mixture of Ouren,Ougon,Hange,Kankyo,Kanzo,Taiso,Ninjin.*20 mixtures of herbal medicine(Prescription dose): Hangeshyashinto(Mixture of Ouren1g,Ougon2.5g,Hange5g,Kankyo2.5g,Kanzo2.5g,Taiso2.5g,Ninjin2.5g).Ourengedokuto(Mixture of Ouren1.5g,Ougon3g,Oubaku3g,Sanshishi3g).Mixture of Ouren,Ougon,Oubaku.Mixture of Ouren,Ougon, Sanshishi.Mixture of Ouren, Oubaku,Sanshishi.Mixture of Ougon,Oubaku,Sanshishi.Mixture of Ouren,Ougon.Mixture of Ouren, Oubaku.Mixture of Ouren,Sanshishi.Mixture of Ougon,Oubaku.Mixture of Ougon, Sanshishi.Mixture of Oubaku,Sanshishi.Precipitate part of the decoction (Mixture of Ouren,Ougong,Oubaku,Sanshishi).Supernatant part of the decoction (Mixture of Ouren,Ougon,Oubaku,Sanshishi). Ourengedokuto(Prescription 1/2dose),(Prescription 1/3dose), (Prescription 1/4dose). Hangeshyashinto(Prescription 1/2dose),(Prescription 1/3dose),(Prescription 1/4dose).
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. Healthy adult
2. Subjects who agree to participate in this study with a written informed consent.
Key exclusion criteria
1. Person with serious underlying disease
2. Pregnant
3. Person currently or continuously taking Kampo medicine.
4.Person with history of adverse effects from taking Kampo medicine.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Iwai |
Organization
School of Pharmacy, Showa University
Division name
Department of Healthcare and Regulatory Science
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8215
s-iwai@pharm.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Nishijima |
Organization
School of Pharmacy, Showa University
Division name
Department of Healthcare and Regulatory Science
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8215
Homepage URL
heiwado@nr.catv.ne.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Heiwado Pharmacy
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
Address
Tel
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
| 2017 | Year | 08 | Month | 29 | 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
| 2017 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2021 | 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
| 2017 | Year | 08 | Month | 28 | Day |
Last modified on
| 2020 | Year | 02 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032938
