UMIN-CTR Clinical Trial

Basic information
Public title	Effect of hangeshashinto on diarrhea associated with chemotherapy
Acronym	Effect of hangeshashinto on diarrhea associated with chemotherapy
Scientific Title	Effect of hangeshashinto on diarrhea associated with chemotherapy
Scientific Title:Acronym	Effect of hangeshashinto on diarrhea associated with chemotherapy
Region	Japan

Condition
Condition	Malignant neoplasms
Classification by specialty	Medicine in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of hangeshashinto on chemotherapy induced diarrhea
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Common Terminology Criteria for Adverse Events: grade 3 and 4 diarrhea
Key secondary outcomes	Common Terminology Criteria for Adverse Events: grade 0 and 2 diarrhea

Base
Study type	Others,meta-analysis etc

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Randomized controlled trials that: Patients: Cancer patients receiving chemotherapy Interventions: Patients using hangeshashinto Comparison: Patients not using hangeshashinto Outcomes: diarrhea
Key exclusion criteria	Wrong study design(non-randomized controlled trial) No assessment of diarrhea
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Takeru Middle name Last name Takahashi
Organization	Akita City Hospital
Division name	Department of Pharmacy
Zip code	0180933
Address	4-30 Matsuoka-machi,Kawamoto, Akita-city, Akita 018-0933 Japan
TEL	018-823-4171
Email	ra33xb86@gmail.com

Public contact
Name of contact person	1st name Takeru Middle name Last name Takahashi
Organization	Akita City Hospital
Division name	Department of Pharmacy
Zip code	0180933
Address	4-30 Matsuoka-machi,Kawamoto, Akita-city, Akita 018-0933 Japan
TEL	018-823-4171
Homepage URL
Email	ra33xb86@gmail.com

Sponsor
Institute	Akita City Hospital
Institute
Department

Funding Source
Organization	None
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	Akita City Hospital
Address	4-30 Matsuoka-machi,Kawamoto, Akita-city, Akita 018-0933 Japan
Tel	018-823-4171
Email	ra33xb86@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	2022 Year 10 Month 07 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	Completed
Date of protocol fixation	2022 Year 10 Month 01 Day
Date of IRB	2022 Year 10 Month 01 Day
Anticipated trial start date	2022 Year 10 Month 11 Day
Last follow-up date	2022 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Search strategy: We will conduct a systematic review and meta-analysis in accordance with the PRISMA statement. We will search databases (MEDLINE, ichusi, CENTRAL, Clinical Trials.gov). Study selection, data extraction, and risk of bias assessment: The retrieved literature will be de-duplicated and two reviewers will independently screen, extract data, and assess the risk of bias in the included articles. Disagreements are resolved by discussion or third-party judgment. The Risk of Bias Tool is used to determine the risk of bias. Meta-analysis and summary of findings: Meta-analysis will be performed using Review Manager (RevMan). Assess the quality of evidence for each outcome using the GRADE(The Grading of Recommendations, Assessment, Development, and Evaluation) approach. Primary outcomes: Grade 3 and 4 diarrhea Secondary outcomes: Grade 0-2 diarrhea

Management information
Registered date	2022 Year 10 Month 03 Day
Last modified on	2022 Year 11 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055942