Phase 4
Completed N=125
The Efficacy and Safety Study of Rikkunshito in Patients With Functional Dyspepsia
Source: ClinicalTrials.gov NCT02037776 ↗Enrolled (actual)
125
Serious AEs
1.6%
Results posted
Jul 2017
Primary outcomePrimary: Patient's Evaluation of Symptomatic Improvement by Overall Treatment Efficacy (OTE) — 1; 5; 13; 18 Participants — p=0.038
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to assess the efficacy and safety of Rikkunshito compared to placebo in Japanese subjects with Functional Dyspepsia (FD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient's Evaluation of Symptomatic Improvement by Overall Treatment Efficacy (OTE) |
1; 5; 13; 18; 25; 26 | 0.038 sig |
| SECONDARY Change From Baseline in Modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (GERD) (Modified FSSG) |
-4.99; -7.18; -1.69; -2.62; -3.29; -4.58 | 0.027 sig |
| SECONDARY Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) |
-0.30; -0.47; -0.23; -0.25; -0.15; -0.33 | 0.051 |
| SECONDARY Change From Baseline in Global Overall Symptom (GOS) |
-4.03; -6.39 | 0.034 sig |
| SECONDARY Change From Baseline in Short-form Health Survey-8 (SF-8) |
2.68; 3.87; 0.24; 1.81 | 0.270 |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression Scale (HAD) |
-0.34; -2.11; -0.05; -0.92; -0.30; -1.19 | 0.036 sig |
Eligibility Criteria
Inclusion Criteria
- -Patients diagnosed with FD according to the ROME III criteria i) Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to obtaining informed consent ii) Have not received upper endoscopy within the last 6 months prior to enrollment and do not have evidence of structural/organic disease iii) Must have one or more of the following symptoms:
- Bothersome postprandial fullness
- Early satiation
- Epigastric pain
- Epigastric burning
- At least one of the FD-related symptoms on the Global Overall Symptom (GOS) scale (bothersome postprandial fullness, early satiation, epigastric pain, epigastric burning) is ≥4, whereas heartburn is ≤3.
- Total score of depression-related symptoms on Hospital Anxiety and Depression Score (HAD) is ≤10.
- Type of visit: Outpatient
- Provides voluntary informed consent after receiving adequate explanation and demonstrates thorough understanding of the nature of the study.
Exclusion Criteria
- Confirmed ulcer (excluding scars) or malignant tumor in the upper GI
- Suspected organic lesions in the hepato-biliary-pancreatic regions such as cholelithiasis, hepatitis, pancreatitis
- History of upper GI resection
- Serious complications (liver, kidney, heart, or blood disease or metabolic disease)
- Less than a year since testing positive for H. pylori or have undergone a successful eradication therapy
- Use of prohibited medications
- Neuropsychiatric disorders
- Use of or planned use of any investigational drugs
- Unable to take drugs orally
- History of allergic reactions to Kampo medicines
- Pregnant or lactating women or those who are planning to conceive during the study period
- Deemed ineligible by principal investigator or sub-investigator
Data sourced from ClinicalTrials.gov (NCT02037776). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.