Functional Heartburn
Conditions
Interventions
Rikkunshito(7.5 g/t.i.d) for 8 weeks
Sponsors
Nippon Medical School Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed with FH according to the Rome IV criteria 2) Patients with indigestion(ARD>=1) 3) FSSG is>=8 4)Patients who are resistant to even more than 2 weeks administration of P-CAB. 5) Type of visit: Outpatient 6) Age: Aged 20 and over 7) Patients for whom oral administration was possible 8) Patients who provided written informed consent regarding study participation.
Exclusion criteria
Exclusion criteria: 1)Patients diagnosed with Eosinophilic esophagitis(EoE) 2)Patients diagnosed with Esophageal Motility disorders by High-Resolution manometry. 3)Patients who had 50% or more of Symptom Index by 24-hour Esophageal Impedance and PH monitoring. 4)Patients diagnosed with Reflux esophagitis(RE)(Los Angeles classification,>=Grade A)by upper endoscopy. 5)History of upper GI resection 6)Confirmed presence of ulcer (excluding scars) or malignant tumor in the upper GI. 7)Suspected organic hepatic/biliary/pancreatic disorders such as gallstone, hepatitis, and pancreatitis 8)History of allergic reactions to Kampo medicines. 9)Patients who were administered KAMPO medicine 4 weeks before entry. 10)Receiving or scheduled to receive an agent that is being developed. 11)Presence of serious complications (liver, kidney, heart, or blood disease or metabolic disease). 12)Pregnant or lactating women or those who are planning to conceive during the study period. 13)Considered ineligible to participate by principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency scale for the symptoms of GERD (FSSG) , (Total.reflux symptom (RS)and acid-related dysmotility symptoms (ARD)) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Quality of Life in Reflux and Dyspepsia : QOLRAD-J (Total , Emotional distress, Sleep disturbance, Vitality,Food/drink problems and Physical/social functioning) 2) Hospital Anxiety and Depression Scale : HADS (Total, Anxiety, Depression) 3) Overall Treatment Efficacy : OTE | — |
Countries
Japan
Contacts
Public ContactNoriyuki Kawami
Nippon Medical School Graduate School of Medicine Department of gastroenterology
Outcome results
None listed