UMIN-CTR Clinical Trial

Public title

The exploratory study for the efficacy and the safety of Rikkunshito on symptoms of indigestion in the patients with Functional Heartburn

Acronym

The efficacy of Rikkunshito on indigestion in the patients with Functional Heartburn

Scientific Title

The exploratory study for the efficacy and the safety of Rikkunshito on symptoms of indigestion in the patients with Functional Heartburn

Scientific Title:Acronym

The efficacy of Rikkunshito on indigestion in the patients with Functional Heartburn

Region

Japan

Condition

Functional Heartburn

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Katsuhiko Iwakiri

Organization

Nippon Medical School Graduate School of Medicine

Division name

Department of gastroenterology

Zip code

Address

1-1-5, Sendagi, Bunkyo-ku,Tokyo,

TEL

03-3822-2131

Email

k-iwa@nms.ac.jp

Name of contact person

1st name
Middle name
Last name	Noriyuki Kawami

Organization

Nippon Medical School Graduate School of Medicine

Division name

Department of gastroenterology

Zip code

Address

1-1-5, Sendagi, Bunkyo-ku,Tokyo,

TEL

03-3822-2131

Homepage URL

Email

s5038@nms.ac.jp

Institute

Nippon Medical School Graduate School of Medicine

Institute

Department

Personal name

Organization

TSUMURA and CO.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

日本医科大学付属病院

Date of disclosure of the study information

2017

Year

10

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2017

Year

09

Month

15

Day

Date of IRB

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

Other related information

Registered date

2017

Year

10

Month

23

Day

Last modified on

2017

Year

10

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033880