UMIN-CTR Clinical Trial

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
Last 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
Email	higuchi@osaka-med.ac.jp

Public contact
1st 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
Email	in2097@osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024516