UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021251 |
|---|---|
| Receipt number | R000024516 |
| Scientific Title | The exploratory study for the efficacy and the safety of Hangeshashinto on symptoms of heartburn /belch in the patients with gastroesophageal reflux disease (GERD) |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2019/03/22 17:13:48 |
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Basic information
Public title
The exploratory study for the efficacy and the safety of Hangeshashinto on symptoms of heartburn /belch in the patients with gastroesophageal reflux disease (GERD)
Acronym
The efficacy of Hangeshasinto on heartburn/belch in the patients with GERD
Scientific Title
The exploratory study for the efficacy and the safety of Hangeshashinto on symptoms of heartburn /belch in the patients with gastroesophageal reflux disease (GERD)
Scientific Title:Acronym
The efficacy of Hangeshasinto on heartburn/belch in the patients with GERD
Region
| Japan |
Condition
Condition
GERD
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and the safety of Hangeshashinto on symptoms of heartburn and belch in PPI refractory GERD patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)reflux symptom(RS),
acid-related dysmotility symptoms(ARD)
and total score of frequency scale for
the symptoms of GERD (FSSG)
(afer treatment 4 weeks)
2)each score of FSSG (12items)
(after treatment 4 weeeks)
Key secondary outcomes
1)GI-related QOL:
5 subscale (abdominal pain,reflux syndrome,diarrhea syndrome, indigestion syndrome and constipation syndrome)and total scores of the Gastrointestinal Symptom Rating Scale(GSRS)
2)the improvement rate:
the rate of GERD patients with total FSSG score<8 after treatment
3)Subgroup analysis by the subject's background factor
(age,gender,BMI,etc.)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Hangeshashinto(7.5 g/t.i.d) and Rabeprazole (10 mg/day) for 4 weeks
Interventions/Control_2
Rabeprazole (20 mg/day) for 4 weeks
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) Patients who were diagnosed with GERD(There is a possibility of reflux esophagitis)
2) Patients with heartburn or burp
3) Patients who had received the treatment with PPI for 4 weeks or more
4) Patients who had 8 or more of FSSG score before the registration
5) No criteria on sex.
6) Type of visit:Outpatient
7) Age: Aged 20 and over
8) Patients for whom oral administration was possible
9) Patients who provided written informed consent regarding study participation.
Key exclusion criteria
1) History of upper GI resection
2) Confirmed presence of ulcer (excluding scars) or malignant tumor in the upper GI.
3) Non-erosive reflux disease (Los Angeles classification, Grade N)
4) suspected organic hepatic/biliary/pancreatic disorders such as gallstone, hepatitis, and pancreatitis
5) History of allergic reactions to Kampo medicines
6)Patients who is taking P-CAB.
7) Patients who were administered KAMPO medicine 4 weeks before entry.
8) receiving or scheduled to receive an agent that is being developed
9) presence of serious complications (liver, kidney, heart, or blood disease or metabolic disease).
10) Pregnant or lactating women or those who are planning to conceive during the study period.
11) considered ineligible to participate by principal investigator or sub-investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhide Higuchi |
Organization
Osaka Medical College
Division name
2nd Department of Internal Medicine
Zip code
Address
2-7 Daigaku-cho, Takatsuki-City, Osaka
TEL
072-683-1221
higuchi@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihisa Takeuchi |
Organization
Osaka Medical College
Division name
2nd Department of Internal Medicine
Zip code
Address
2-7 Daigaku-cho, Takatsuki-City, Osaka
TEL
072-683-1221
Homepage URL
in2097@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
TSUMURA and CO.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
大阪医科大学病院（大阪府）、むらのクリニック（大阪府）、森田内科・胃腸内科（大阪府）、摂津診療所（大阪府）、もりた内科・胃腸内科（大阪府）、藤田胃腸科病院（大阪府）、浜本クリニック（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 01 | 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
| 2016 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 03 | Month | 22 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 29 | Day |
Last modified on
| 2019 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024516
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