UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003954
Receipt No. R000004763
Scientific Title Double-blind, randomized, placebo-controlled trial to examine the efficacy and the safety of Rikkunshito for Functional Dyspepsia
Date of disclosure of the study information 2010/07/27
Last modified on 2014/05/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
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
Condition Functional Dyspepsia
Classification by specialty
Medicine in general Gastroenterology Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Office of Rikkunshito study
Institute
Department

Funding Source
Organization Minister of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

Result
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

Progress
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
Other related information

Management information
Registered date
2010 Year 07 Month 27 Day
Last modified on
2014 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004763

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.