Skip to content

Effect of ninjin'yoeito on the skeletal muscle mass in gastric cancer patients: a multicenter randomized controlled trial

Effect of ninjin'yoeito on the skeletal muscle mass in gastric cancer patients: a multicenter randomized controlled trial - Effect of ninjin'yoeito on the skeletal muscle mass in gastric cancer patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000041840
Enrollment
52
Registered
2020-10-01
Start date
2020-09-18
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

No medication Kracie Ninjin&#39
yoeito Extract Granules, 7.5g per day

Sponsors

Department of Surgery, Nara Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed clinical stage I-III gastric cancer 2) At least one of the following symptoms: decreased strength after illness, fatigue/malaise, anorexia, night sweats, cold limbs or anemia 3) Age of 20 years or older 4) Eastern Cooperative Oncology Group performance status of 0-2 5) Sufficient oral intake 6) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients scheduled to preoperative chemotherapy and/or radiotherapy 2) Any Japanese herbal medicine within 4 weeks before the commencement of the study 3) Allergy to Japanese herbal medicine 4) Severe comorbidities, such as liver disease, renal disease, heart disease, lung disease, hematologic disease and metabolic disease 5) Electrolyte abnormalities 6) Cardiac pacemaker 7) Severe mental disorder 8) Pregnancy 9) Patient who is judged to be unsuitable for inclusion in the study by the investigators

Design outcomes

Primary

MeasureTime frame
Change of the ratio of skeletal muscle mass to body weight

Secondary

MeasureTime frame
(1) Change of body composition (2) Change of nutritional parameters (3) Adverse events and postoperative complications

Countries

Japan

Contacts

Public ContactSohei Matsumoto

Nara Medical University Surgery

msohei@naramed-u.ac.jp0744-29-8863

Outcome results

None listed

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