UMIN-CTR Clinical Trial

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
Email	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
Email	heiwado@nr.catv.ne.jp

Sponsor
Institute	Showa University
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032938