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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
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000042853
Enrollment
200
Registered
2021-03-01
Start date
2021-03-01
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

Lung cancer

Interventions

Three packets of 3.0g (9.0g)of Ninjin&#39
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. Patients do not take Ninjin&#39
yoeito.

Sponsors

Tokyo Medical and Dental University
Lead Sponsor

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

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

Secondary

MeasureTime 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.—

Countries

Japan

Contacts

Public ContactHironori Ishibashi

Tokyo Medical and Dental University Department of Thoracic Surgery, Graduate school of Medical and Dental Sciences

hishiba.thsr@tmd.ac.jp03-5803-4072

Outcome results

None listed

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