UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Kampo formula on oxidative stress
Title of the study (Brief title)	Kampo and oxidative stress
Region	Japan

Condition
Condition	Patients who receives Kampo formula treatments
Classification by specialty	Medicine in general Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, we evaluate the effect of Kampo, Japanese traditional herbal medicine, on oxidative stress using state-of-the-art technology using patients samples ex vivo, and analyze the relationship with the pathophysiological status.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Oxidative stress marker (MULTIS)
Key secondary outcomes	Oxidative stress and inflammation markers: iStrap, IL-6, TNF-a, adiponectin, CRP

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. Patient diagnosed as "Sho (pattern)" to the corresponding Kampo formula. 2. Patient newly treated with the corresponding Kampo formula for more than 12 weeks. 3. Patients who showed consent to this research. Kampo: Go-sha-jinki-Gan, Hachimi-jio-Gan, Saiko-ka-ryukotsu-borei-To, Oren-gedoku-To, Keishi-bukuryo-Gan, Toki-shakuyaku-San, Saiko-keishi-kankyo-To, Kami-kihi-To.
Key exclusion criteria	1. Those who can not obtain consent to participate in research. 2. Those who can not express self-will 3. Those judged to be inappropriate by the researchers or research sharing doctor 4. Those who already medicated with Kampo formulation(s) constantly, and change(s) or addition(s) of new Kampo formulation(s) are made within the two weeks before the start of this investigation.
Target sample size	80

Research contact person
Name of lead principal investigator	Aki Hirayama
Organization	Tsukuba University of Technology
Division name	Center for Integrative Medicine
Address	4-12-7 Kasuga, Tsukuba, Japan
TEL	0298589590
Email	aki-hira@k.tsukuba-tech.ac.jp

Public contact
Name of contact person	Aki Hirayama
Organization	Tsukuba University of Technology
Division name	Center for Integrative Medicine
Address	4-12-7 Kasuga, Tsukuba, Japan
TEL	0298589590
Homepage URL
Email	aki-hira@k.tsukuba-tech.ac.jp

Sponsor
Institute	Center for Integrative Medicine Tsukuba University of Technology
Institute
Department

Funding Source
Organization	Tsukuba University of Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

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	筑波技術大学東西医学統合医療センター

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 12 Month 28 Day
Anticipated trial start date	2019 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Observation Oxidative stress markers; (MULTIS, iStrap, 8-OHdG, IL-6, adiponectin), Clinical information (history, clinical examination results).

Management information
Registered date	2019 Year 01 Month 15 Day
Last modified on	2019 Year 01 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040324