UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049104 |
|---|---|
| Receipt number | R000055942 |
| Scientific Title | Effect of hangeshashinto on diarrhea associated with chemotherapy |
| Date of disclosure of the study information | 2022/10/07 |
| Last modified on | 2022/11/23 14:11:54 |
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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
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
ra33xb86@gmail.com
Sponsor or person
Institute
Akita City Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055942
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
