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A pilot study to plan a protocol for the clinical trial evaluating the efficacy of Rikkunshito for patients after total gastrectomy

A pilot study to plan a protocol for the clinical trial evaluating the efficacy of Rikkunshito for patients after total gastrectomy - A pilot study to evaluate the efficacy of Rikkunshito for patients after total gastrectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024364
Enrollment
10
Registered
2016-11-01
Start date
2017-04-01
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

Interventions

Oral administration of Rikkunshito 7.5g per day for 84 days from post operative day three. No oral administration of Rikkunshito perioperatively.

Sponsors

Jichi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Histological proven adenocarcinoma of stomach 2. cT1-T4a and no distant metastasis 3. R0 resection with total gastrectomy 4. Age 20-80 years 5. Eastern Cooperative Oncology Group performance status 0-1 6. Normal function of organ systems 7. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Synchronous or metachronous cancer 2. Reduced oral intake 3. Past gastrointestinal surgery 4. Preoperative chemotherapy 5. Administration of Rikkunshito ingredients before surgery 6. Unstable angina or myocardial infarction within six months 7. Pulmonary disease treated with continuous oxygen 8. Hemorrhagic tendency 9. Diabetes mellitus 10. Systemic treatment with corticosteroids 11. Pregnancy, breast-feeding, or contemplating pregnancy. 12. Mental disorder that affects informed consent or study protocol

Design outcomes

Primary

MeasureTime frame
Weight loss at three months after surgery

Secondary

MeasureTime frame
Medication compliance of Rikkunshito Adverse events associated with Rikkunshito Quality of life score Plasma glucagon-like peptide-1

Countries

Japan

Contacts

Public ContactYoshinori Hosoya

Jichi Medical University Hospital Department of Surgery

hosoyo@jichi.ac.jp0285-58-7371

Outcome results

None listed

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