Unique ID issued by UMIN | UMIN000006881 |
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Receipt number | R000008128 |
Scientific Title | Double-blind, randomized, placebo-controlled trial to examine the efficacy and the safety of Rikkunshito for PPI resistant Functional Dyspepsia |
Date of disclosure of the study information | 2011/12/26 |
Last modified on | 2014/05/09 13:07:08 |
Double-blind, randomized, placebo-controlled trial to examine the efficacy and the safety of Rikkunshito for PPI resistant Functional Dyspepsia
Double-blind, randomized, placebo-controlled trial to examine the efficacy and the safety of Rikkunshito for PPI resistant Functional Dyspepsia
Double-blind, randomized, placebo-controlled trial to examine the efficacy and the safety of Rikkunshito for PPI resistant Functional Dyspepsia
Double-blind, randomized, placebo-controlled trial to examine the efficacy and the safety of Rikkunshito for PPI resistant Functional Dyspepsia
Japan |
Functional Dyspepsia
Medicine in general | Gastroenterology | Surgery in general |
Others
NO
To examine the efficacy and safety of Rikkunshito in PPI resisitant Functional Dyspepsia by double-blind, randomized, placebo-controlled trial
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Improvement rate of Global Patient Assessment(GPA) at 8 weeks after initial treatment
Rate of Gastrointestinal Symptom Rating Scale(GSRS) after treatment
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 aged 20 or older
4.regardless of sex
5.regardless of admission to hospital
6.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
120
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, Shinjuku-ku, Tokyo, 160-8582, Japan
03-5363-3914
hsuzuki@a6.keio.jp
1st name | |
Middle name | |
Last name | Naoki Tomotsugu |
Keio University School of Medicine
Center for Clinical Research
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
03-5363-3288
mami142143@gmail.com
Office of Rikkunshito Study
Minister of Health, Labour and Welfare
NO
2011 | Year | 12 | Month | 26 | Day |
Unpublished
Terminated
2011 | Year | 12 | Month | 12 | Day |
2012 | Year | 03 | Month | 01 | Day |
2012 | Year | 09 | Month | 30 | Day |
2012 | Year | 09 | Month | 30 | Day |
2012 | Year | 09 | Month | 30 | Day |
2012 | Year | 09 | Month | 30 | Day |
2011 | Year | 12 | Month | 13 | Day |
2014 | Year | 05 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008128
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