UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The exploratory study for the efficacy and the safety of Rikkunshito on symptoms of indigestion in the patients with Functional Heartburn
Title of the study (Brief title)	The efficacy of Rikkunshito on indigestion in the patients with Functional Heartburn
Region	Japan

Condition
Condition	Functional Heartburn
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and the safety of Rikkunshito on symptoms of indigestion in the patients with Functional Heartburn.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Frequency scale for the symptoms of GERD (FSSG) , (Total.reflux symptom (RS)and acid-related dysmotility symptoms (ARD))
Key secondary outcomes	1) Quality of Life in Reflux and Dyspepsia : QOLRAD-J (Total , Emotional distress, Sleep disturbance, Vitality,Food/drink problems and Physical/social functioning) 2) Hospital Anxiety and Depression Scale : HADS (Total, Anxiety, Depression) 3) Overall Treatment Efficacy : OTE

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Rikkunshito(7.5 g/t.i.d) for 8 weeks
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients diagnosed with FH according to the Rome IV criteria 2) Patients with indigestion(ARD>=1) 3) FSSG is>=8 4)Patients who are resistant to even more than 2 weeks administration of P-CAB. 5) Type of visit: Outpatient 6) Age: Aged 20 and over 7) Patients for whom oral administration was possible 8) Patients who provided written informed consent regarding study participation.
Key exclusion criteria	1)Patients diagnosed with Eosinophilic esophagitis(EoE) 2)Patients diagnosed with Esophageal Motility disorders by High-Resolution manometry. 3)Patients who had 50% or more of Symptom Index by 24-hour Esophageal Impedance and PH monitoring. 4)Patients diagnosed with Reflux esophagitis(RE)(Los Angeles classification,>=Grade A)by upper endoscopy. 5)History of upper GI resection 6)Confirmed presence of ulcer (excluding scars) or malignant tumor in the upper GI. 7)Suspected organic hepatic/biliary/pancreatic disorders such as gallstone, hepatitis, and pancreatitis 8)History of allergic reactions to Kampo medicines. 9)Patients who were administered KAMPO medicine 4 weeks before entry. 10)Receiving or scheduled to receive an agent that is being developed. 11)Presence of serious complications (liver, kidney, heart, or blood disease or metabolic disease). 12)Pregnant or lactating women or those who are planning to conceive during the study period. 13)Considered ineligible to participate by principal investigator or sub-investigator.
Target sample size	20

Research contact person
Name of lead principal investigator	Katsuhiko Iwakiri
Organization	Nippon Medical School Graduate School of Medicine
Division name	Department of gastroenterology
Address	1-1-5, Sendagi, Bunkyo-ku,Tokyo,
TEL	03-3822-2131
Email	k-iwa@nms.ac.jp

Public contact
Name of contact person	Noriyuki Kawami
Organization	Nippon Medical School Graduate School of Medicine
Division name	Department of gastroenterology
Address	1-1-5, Sendagi, Bunkyo-ku,Tokyo,
TEL	03-3822-2131
Homepage URL
Email	s5038@nms.ac.jp

Sponsor
Institute	Nippon Medical School Graduate School of Medicine
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)

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	日本医科大学付属病院

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 24 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 09 Month 15 Day
Anticipated trial start date	2017 Year 10 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 10 Month 23 Day
Last modified on	2017 Year 10 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033880