Double-blind Trial with Rikkunshito versus Placebo on Efficacy and Safety in Patients with Functional Dyspepsia :Multi-center Study

Not Applicable

• Conditions: Functional Dyspepsia

• Registration Number: JPRN-UMIN000012808
• Lead Sponsor: DREAM study group

Brief Summary

In this study, 128 patients were included in the safety analysis set and 125 were included in the full analysis set (FAS). As for demographic characteristics in the FAS, there were more women (89 patients) than men (36 patients); mean age was 50.4; mean BMI was 21.2 kg/m2; 82 patients had duration of FD >1 year. Regarding a subtype of FD, 49 patients had a PDS subtype, 42 had an EPS, and 34 had overlapping PDS-EPS. A total of 114 patients had no overlapping with IBS. In the analysis of the score distribution of 7 categories in OTE at the final data (i.e., the latest evaluable time point of the all patients including discontinued patients) in the FAS, a primary endpoint of this study, the patients in Rikkunshito group ranged between score 1 and 4, those in Rikkunshito placebo group (including those worsened) ranged between score 1 and 5, and statistically significant differences were observed (p=0.038). In the secondary endpoints, changes from baseline at the final data were statistically significant differences between groups in a total scores of Modified FSSG, GOS score, subscores of Postprandial Fullness/Early satiety and Bloating in PAGI-SYM, as well as overall score and Anxiety subscore of HAD. No statistical differences were observed in either PCS or MCS score of SF-8. In the safety analysis set, the incidence of AEs was 10.8% (7/65 patients) in Rikkunshito group and 11.1% (7/63) in Rikkunshito placebo group. The most common AEs reported by SOC were Gastrointestinal disorders in the both groups (4 patients in Rikkunshito group, 3 in Rikkunshito placebo group). The incidence of ADRs was 4.6% (constipation, diarrhoea, and faeces soft, 1 patient each) in Rikkunshito group and 1.6% (rush, 1 patient) in Rikkunshito placebo group. SAEs were reported from 2 patients in Rikkunshito placebo group (cervix carcinoma, rush). No death occurred in this study.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-31
• Study Completion: 2016-03-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

Not provided

Exclusion Criteria

1.Confirmed ulcer (excluding scars) or malignant tumor in the upper GI. 2.Suspected organic lesions in the hepato-biliary-pancreatic regions such as cholelithiasis, hepatitis, pancreatitis. 3.History of upper GI resection. 4.Serious complications (liver, kidney, heart, or blood disease or metabolic disease). 5.Less than a year since testing positive for H. pylori or have undergone asuccessful eradication therapy. 6.Use of prohibited medications. 7.Neuropsychiatric disorders. 8.Use of or planned use of another investigational drug. 9.Unable to take drugs orally. 10.History of allergic reactions to Kampo medicines. 11.Pregnant or lactating women or those who are planning to conceive during the study period. 12.Deemed ineligible by principal investigator or sub-investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified