UMIN-CTR Clinical Trial

Public title

Double-blind, randomized, placebo-controlled trial to examine the efficacy and the safety of Rikkunshito for Functional Dyspepsia

Acronym

Double-blind, randomized, placebo-controlled trial to examine the efficacy and the safety of Rikkunshito for Functional Dyspepsia

Scientific Title

Double-blind, randomized, placebo-controlled trial to examine the efficacy and the safety of Rikkunshito for Functional Dyspepsia

Scientific Title:Acronym

Double-blind, randomized, placebo-controlled trial to examine the efficacy and the safety of Rikkunshito for Functional Dyspepsia

Region

Japan

Condition

Functional Dyspepsia

Classification by specialty

Medicine in general	Gastroenterology	Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the efficacy and safety of Rikkunshito in Functional Dyspepsia by double-blind, randomized, placebo-controlled trial

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Improvement rate of global patient assessment at 8 weeks after initial treatment

Key secondary outcomes

1.Rate of Gastrointestinal Symptom Rating Scale(GSRS) after treatment
2.Improvement rate of dyspeptic symptoms by symptomatic scale

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

traditional Chinese medicine

Interventions/Control_2

placebo

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 with functional dyspepsia diagnosed according to the Rome three classification
2. Patients with dyspeptic symptom by symptomatic scale 3 points or more, for over four days, for two weeks before registration
3.Patients have average 4 points or more by abdominal pain domain or dyspepsia domain of GSRS, or patients have 5 points or more, at one more items of abdominal pain domain or dyspepsia domain of GSRS
4.Patients aged 20 or older
5.regardless of sex
6.regardless of admission to hospital
7.Patients whose written informed consent has been obtained

Key exclusion criteria

1. Patient with Organic disease such as reflux esophagitis (> grade A) and erosive gastritis.
2. Patients with past history of upper gastrointestinal surgery
3. Patients with past history of gastrectomy
4.Patients with an obvious cause of symptom
5. NSAIDs or low-dose aspirin -related dyspepsia
6. Patients with organic disease in the brain or with psychological disorders
7. Patients with alcoholics or with drug dependence
8. Severe endocrine disease including hyperthyroidism
9. Severe diseases in heart, liver and kidney. Severe infectious or hemotological diseases
10. Drug allegy for Rikkunshito
11.Expectant mother, mother with breast-feeding, or females who wish to become pregnant
12.Patient with H.pylori eradication within 6 months
13.Patients who take gastric secretion inhibitor, prokinetic agent, gastric antacid, anticholineric drug, cholinergic agent, tranquilizer, anxiolytic agent drug, antidepressive drug within 1 week
14. Patients with suspected IBS
15. other not applicable person recognized by a doctor

Target sample size

430

Name of lead principal investigator

1st name
Middle name
Last name	Hidekazu Suzuki, M.D., Ph.D.

Organization

Keio University School of Medicine

Division name

Division of Gastroenterology and Hepatology, Department of Internal Medicine

Zip code

Address

35 Shinanomachi, Shinjyuku-ku, Tokyo, 160-8582, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Naoki Tomotsugu, Ph.D.

Organization

Keio University School of Medicine

Division name

Center for Clinical Research

Zip code

Address

35 Shinanomachi, Shinjyuku-ku, Tokyo, 160-8582, Japan

TEL

03-5363-3288

Homepage URL

Email

Institute

Office of Rikkunshito study

Institute

Department

Personal name

Organization

Minister of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

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

Date of disclosure of the study information

2010

Year

07

Month

27

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://onlinelibrary.wiley.com/doi/10.1111/nmo.12348/full

Number of participants that the trial has enrolled

Results

BACKGROUND:
Rikkunshito, a standardized Japanese herbal medicine, is thought to accelerate gastric emptying and relieve dyspepsia, although no large-scale, randomized, placebo-controlled trials of rikkunshito have been conducted. This study aimed to determine the efficacy and safety of rikkunshito for treating functional dyspepsia (FD).

METHODS:
FD patients received 2.5 g rikkunshito or placebo three times a day for 8 weeks in this multicenter, randomized, placebo-controlled, parallel-group trial. The primary end point was the proportion of responders at 8 weeks after starting test drug, determined by global patient assessment (GPA). The improvement in four major dyspepsia symptoms severity scale was also evaluated. In addition, plasma ghrelin levels were investigated before and after treatment.

KEY RESULTS:
Two hundred forty-seven patients were randomly assigned. In the eighth week, the rikkunshito group had more GPA responders (33.6%) than the placebo (23.8%), although this did not reach statistical significance (p = 0.09). Epigastric pain was significantly improved (p = 0.04) and postprandial fullness tended to improve (p = 0.06) in the rikkunshito group at week 8. Rikkunshito was relatively more effective among Helicobacter pylori-infected participants (rikkunshito: 40.0% vs placebo: 20.5%, p = 0.07), and seemed less effective among H. pylori-uninfected participants (rikkunshito: 29.3% vs placebo: 25.6%, p = 0.72). Among H. pylori-positive individuals, acyl ghrelin levels were improved just in rikkunshito group. There were no severe adverse events in both groups.

CONCLUSIONS & INFERENCES:
Administration of rikkunshito for 8 weeks reduced dyspepsia, particularly symptoms of epigastric pain and postprandial fullness. (UMIN Clinical Trials Registry, Number UMIN000003954).

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

Completed

Date of protocol fixation

2010

Year

11

Month

15

Day

Date of IRB

Anticipated trial start date

2011

Year

02

Month

01

Day

Last follow-up date

2013

Year

04

Month

30

Day

Date of closure to data entry

2013

Year

05

Month

31

Day

Date trial data considered complete

2013

Year

06

Month

30

Day

Date analysis concluded

2013

Year

07

Month

31

Day

Other related information

Registered date

2010

Year

07

Month

27

Day

Last modified on

2014

Year

05

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004763