Unique ID issued by UMIN | UMIN000003954 |
---|---|
Receipt number | 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 13:04:54 |
Double-blind, randomized, placebo-controlled trial to examine the efficacy and the safety of Rikkunshito for Functional Dyspepsia
Double-blind, randomized, placebo-controlled trial to examine the efficacy and the safety of Rikkunshito for Functional Dyspepsia
Double-blind, randomized, placebo-controlled trial to examine the efficacy and the safety of Rikkunshito for Functional Dyspepsia
Double-blind, randomized, placebo-controlled trial to examine the efficacy and the safety of Rikkunshito for Functional Dyspepsia
Japan |
Functional Dyspepsia
Medicine in general | Gastroenterology | Gastrointestinal surgery |
Others
NO
To examine the efficacy and safety of Rikkunshito in Functional Dyspepsia by double-blind, randomized, placebo-controlled trial
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Improvement rate of global patient assessment at 8 weeks after initial treatment
1.Rate of Gastrointestinal Symptom Rating Scale(GSRS) after treatment
2.Improvement rate of dyspeptic symptoms by symptomatic scale
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Medicine |
traditional Chinese medicine
placebo
20 | years-old | <= |
Not applicable |
Male and Female
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
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
430
1st name | |
Middle name | |
Last name | Hidekazu Suzuki, M.D., Ph.D. |
Keio University School of Medicine
Division of Gastroenterology and Hepatology, Department of Internal Medicine
35 Shinanomachi, Shinjyuku-ku, Tokyo, 160-8582, Japan
1st name | |
Middle name | |
Last name | Naoki Tomotsugu, Ph.D. |
Keio University School of Medicine
Center for Clinical Research
35 Shinanomachi, Shinjyuku-ku, Tokyo, 160-8582, Japan
03-5363-3288
Office of Rikkunshito study
Minister of Health, Labour and Welfare
Japan
NO
2010 | Year | 07 | Month | 27 | Day |
Published
http://onlinelibrary.wiley.com/doi/10.1111/nmo.12348/full
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).
Completed
2010 | Year | 11 | Month | 15 | Day |
2011 | Year | 02 | Month | 01 | Day |
2013 | Year | 04 | Month | 30 | Day |
2013 | Year | 05 | Month | 31 | Day |
2013 | Year | 06 | Month | 30 | Day |
2013 | Year | 07 | Month | 31 | Day |
2010 | Year | 07 | Month | 27 | Day |
2014 | Year | 05 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004763