The exploratory study for the efficacy and safety of rikkunshito on gastrointestinal symptoms in the patients who underwent gastrectomy

The exploratory study for the efficacy and safety of rikkunshito on gastrointestinal symptoms in the patients who underwent gastrectomy - The efficacy and safety of rikkunshito on gastrointestinal symptoms after gastrectomy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010873

Enrollment

Registered

2013-06-07

Start date

2013-06-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer patient who underwent gastrectomy

Interventions

Oral administration of rikkunshito (2.5g t.i.d) before meals for 162 days

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who underwent LAPPG or LADG 2) Reconstructive surgery: no object 3) Staging of gastric cancer is IA (UICC TNM classification) 4) Patients with anorexia, early satiation, or postprandial fullness 7 days after surgery 5) Age: &#8805; 20 6) Gender: no object 7) Outpatient or inpatient: no object 8) Agreement to sign an informed consent

Exclusion criteria

Exclusion criteria: 1) Patients who have nutritional disorder before surgery 2) Patients who have another active malignancy 3) Patients with severe complications(ASA >=3 or PS>=2) 4) Patients with gastrointestinal bleeding, mechanical ileus, gastrointestinal perforation 5) Patients with mental disorder considered inappropriate by the study doctor 6) Patients with adjuvant chemotherapy after surgery 7) Patients receiving KAMPO medicine 8) Patients who has history of hypersensitivity to Kampo medicine 9) Patients who are pregnant, considering pregnancy or lactation 10) Patients considered inappropriate by the study investigator

Design outcomes

Primary

Measure	Time frame
1) QOL score (ES3/EGQ, GSRS, SF-12) 2) body weight 3) body mass index 4) nutritional factor (Alb, Pre-Alb, TP, T-Cho, WBC, Lym)	—

Secondary

Measure	Time frame
1)AST,ALT, GGTP,ALP,T-Bil, RBC, Hb, Hct, CRP, Na, K, creatinine, BUN 2)adverse events 3)side effects	—

Countries

Japan

Contacts

Public ContactNaoki Hiki

The Cancer Institute Hospital of JFCR Gastroenterological Surgery

03-3520-0111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026