The efficacy of Rikkunshito on indigestion in the patients with Functional Heartburn

JRCT ID: jRCTs031180206

Registered date:07/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Functional Heartburn
• Date of first enrollment: 29/11/2017
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Oral administration of Rikkunshito 2.5g given on 3 times a day before meals.

Outcome(s)

• Primary Outcome: Total score of frequency scale for the symptoms of GERD (FSSG), acid-related dysmotility symptoms(ARD) and reflux symptom(RS)
• Secondary Outcome: QOLRAD-J(Quality of Life in Reflux and Syapepsia) sore,HADS score, OTE(overall Treatment Efficacy)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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) Patients for whom oral administration was possible
(7) Patients who provided written informed consent regarding study participation

Exclude 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

Related Information

• Primary Sponsor: Iwakiri Katsuhiko
• Secondary Sponsor: TSUMURA & CO,TSUMURA & CO
• Secondary ID(s): UMIN000029668