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Therapeutic Effects of Ninjin'yoeito on Fatigue During Treatment for Advanced Prostate Cancer

Therapeutic Effects of Ninjin'yoeito on Fatigue During Treatment for Advanced Prostate Cancer - Therapeutic Effects of Ninjin'yoeito on Fatigue During Treatment for Advanced Prostate Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000058265
Enrollment
50
Registered
2025-06-25
Start date
2023-04-13
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue during treatment for advanced prostate cancer

Interventions

None listed

Sponsors

Dr. Kazuyoshi Nakamura, Department of Urology, Kimitsu Chuo Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Patients must be diagnosed with advanced prostate cancer, use novel antiandrogenic agents or chemotherapy, and have fatigue/tiredness as side effects. Specifically, patients with a score of 1 or more in each of the FACIT-F categories of feeling tired and feeling fatigue will be targeted for participation in this study. After receiving a thorough explanation of their participation in this study, and with their full understanding and free and voluntary consent, the research subjects will receive 3 g of Ninjin'yoeito before each meal for 4 weeks as the scheduled oral treatment. Patients

Exclusion criteria

Exclusion criteria: Patients who are allergic to Kampo medicine Patients who are already taking Kampo medicine internally Other patients who are deemed inappropriate as research subjects by the principal investigator or subinvestigator

Design outcomes

Primary

MeasureTime frame
Observe the value of the score of the questionnaire FACIT-F and its change before and after (after 1 month) the administration of Ninjin'yoeito Observe changes in d-ROMs test and BAP test values before and after (after 1 month) administration of Ninjin'yoeito

Secondary

MeasureTime frame
Laboratory tests: items measured in daily practice (WBC, RBC, Hb, Hct, Plt, GOT, GPT, T-Bil, TP, ALB, BUN, CRE, CRP, Na, K, Ca, PSA, urine sugar, urine protein, urine occult blood, urine ketone bodies, urine red blood cells, urine white blood cells) Adverse events (onset date, outcome, date of)

Countries

Japan

Contacts

Public ContactKAZUYOSHI NAKAMURA

Kimitsu Chuo Hospital urology

oarsmansoul2000@yahoo.co.jp0438361071

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026