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Efficacy of perioperative Ninjin-yoei-to administration for skeletal muscle mass and weight loss after gastrectomy for gastric cancer: a randomised open-label trial

Efficacy of perioperative Ninjin-yoei-to administration for skeletal muscle mass and weight loss after gastrectomy for gastric cancer: a randomised open-label trial - Efficacy of perioperative Ninjin-yoei-to administration for skeletal muscle mass and weight loss after gastrectomy for gastric cancer: a randomised open-label trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000041167
Enrollment
40
Registered
2020-08-01
Start date
2020-08-01
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

The arm of Ninjin-yoei-to. Take 2.5 g of Ninjin-yoei-to before each meal or between meals. The oral period will be from 2 weeks before surgery to 24 weeks after surgery. Do not take Ninjin-yoei-to.

Sponsors

Showa University Fujigaoka Hospital Department of Gastroenterological and General Surgery
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who are admitted to outpatient department of gastroenterology or general surgery at Showa University Fujigaoka Hospital 2) Patients with histologically confirmed gastric cancer 3) Patients with clinical progress I to III who meet the indication for gastrectomy according to the 5th edition of the Guideline for Gastric Cancer Treatment 4)Patients who are 20 years or older and have PS0 or 1 at the time of obtaining consent 5)Patients who gave their informed consent to participate in this trial

Exclusion criteria

Exclusion criteria: 1) Patients with residual gastric cancer 2) Patients with gastrointestinal obstruction due to tumor 3) Patients who received preoperative chemotherapy or radiation therapy for gastric cancer 4) Patients who perform simultaneous resection of other organs other than gallbladder 5) Patients with infectious diseases that require systemic treatment 6) Patients who have comorbidies, or who are taking oral medication that interferes with the determination of efficacy in measuring the number of white blood cells and lymphocytes. 7) Patients with serious liver/renal disorders or cardiopulmonary diseases that may affect the safety evaluation of drugs 8) Patients who have been given Chinese herbal medicines 4 weeks before the start of the study 9)Patients who have a history of allergy to herbal medicine 10) Patients who are judged to be ineligible by the research doctor

Design outcomes

Primary

MeasureTime frame
Change rate of skeletal muscle mass and body weight 1, 3 and 6 months after gastrectomy

Secondary

MeasureTime frame
Perioperative systemic inflammation markers, body composition analysis, grip strength, postoperative complications, surgery-related death

Countries

Japan

Contacts

Public Contacttsuneyuki uchida

Showa University Fujigaoka Hospital Department of Gastroenterological and General Surgery

t_uchida@med.showa-u.ac.jp045-971-1151

Outcome results

None listed

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