Efficacy of oral Ninjin'yoeito for improvement of fatigability and nutritional status in the perioperative period of primary lung cancer

A randomized, open-label, parallel-group study of the efficacy of oral Ninjin'yoeito in improving fatigability and nutritional status in the perioperative period of primary lung cancer - Efficacy of oral Ninjin'yoeito for improvement of fatigability and nutritional status in the perioperative period of primary lung cancer

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1031210136

Enrollment

332

Registered

2021-06-09

Start date

2021-10-01

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

Primary lung cancer primary lung cance, non-small cell lung cancer, small cell lung cancer

Interventions

1. Three packets of 3.0g (9.0g)of Ninjin'yoeito per day should be taken before or between meals. The dosage should be taken from 2 weeks before to 24 weeks after surgery for primary lung cancer. 2. Pa

C072867

Ninjin'yoeito

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged 65 years or older who will undergo anatomical lung resection and systematic lymph node dissection for primary lung cancer at our department. 2. Patients who have given written consent for this study. 3. Patients with primary lung cancer in stages 0, I, II and III.

Exclusion criteria

Exclusion criteria: 1. The patient does not give consent to participate in the study. 2.The patient has a history of allergy to Ninjin'yoeito or its components. 3. The patient has severe anorexia, nausea, or vomiting, which is a cautious administration of the study drug. 4. The patient with severe hepatic or renal dysfunction.

Design outcomes

Primary

Measure	Time frame
Chalder Fatigue Scale before administration of Ninjin'yoeito, a month after surgery, and 6 months after surgery.	—

Secondary

Measure	Time frame
Cancer Fatigue Scale, Kihon Checklist (KCL), and Controlling nutrition status (COUNT)and Prognostic nutritional index(PNI) before administration of Ninjin'yoeito, a month after surgery, and 6 months after surgery.	—

Contacts

Public ContactHironori Ishibashi

Institute of Science Tokyo

hishiba.thsr@tmd.ac.jp+81-3-5803-4072

Outcome results

None listed

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