UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051607 |
|---|---|
| Receipt number | R000058885 |
| Scientific Title | To examine the symptom improvement advantage of FD patients and the significance of autonomic function measurements. |
| Date of disclosure of the study information | 2023/07/14 |
| Last modified on | 2023/07/13 23:13:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study on the significance of reset training in patients with functional dyspepsia and verification of the involvement of the autonomic nervous system.
Acronym
A study on the significance of reset training in patients with functional dyspepsia and verification of the involvement of the autonomic nervous system.
Scientific Title
To examine the symptom improvement advantage of FD patients and the significance of autonomic function measurements.
Scientific Title:Acronym
To examine the symptom improvement advantage of FD patients and the significance of autonomic function measurements.
Region
| Japan |
Condition
Condition
Patients with functional dyspepsia (FD)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the symptom improvement advantage of FD patients using a cognitive behavioral therapy program (CBT) and the significance of autonomic function measures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Symptom Improvement Rate (Overall Response (OR)) with Reset Training
2.Rate of improvement of gastric discomfort symptoms (VAS)
Key secondary outcomes
1.Reset Training Success Rate of Drug Reduction (with concomitant drug therapy)
2.Relationship between symptom severity and autonomic function
3.Relationship between subjective and objective assessment of autonomic function
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Reset Training (cognitive behavioral therapy program)
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients seen in our clinic who have been diagnosed with functional dyspepsia (FD)
2.Persons who have been fully informed of the purpose and content of the study, have the capacity to consent, and have voluntarily volunteered to participate based on a thorough understanding of the study, and who have given their consent to participate in the study in writing.
Key exclusion criteria
1.Persons who are judged by the investigator to be unsuitable for this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Shimizu |
Organization
Medical Corporation Tsumugiai-kai Shin Itabashi Clinic
Division name
Medical Corporation Tsumugiai-kai Shin Itabashi Clinic
Zip code
173-0004
Address
4-4-4, Itabashi, Itabashi-ku, Tokyo
TEL
03-5248-5715
koichishimizu@tbz.t-com.ne.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Shimizu |
Organization
Medical Corporation Tsumugiai-kai Shin Itabashi Clinic
Division name
Medical Corporation Tsumugiai-kai Shin Itabashi Clinic
Zip code
173-0004
Address
4-4-4, Itabashi, Itabashi-ku, Tokyo
TEL
03-5248-5715
Homepage URL
koichishimizu@tbz.t-com.ne.jp
Sponsor or person
Institute
Medical Corporation Tsumugiai-kai Shin Itabashi Clinic
Institute
Department
Personal name
Funding Source
Organization
Medical Corporation Tsumugiai-kai Shin Itabashi Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Yurinokai Hospital Clinical Trial Review Committee
Address
11-186 Yurigahara, Kita-ku, Sapporo-shi, Hokkaido
Tel
011-771-1501
info@yurinokai.jp
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
| 2023 | Year | 07 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 07 | 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
| 2023 | Year | 07 | Month | 13 | Day |
Last modified on
| 2023 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058885
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
