Safety and efficacy of Kamikihito for the treatment of anxiety and insomnia in castration resistant prostate cancer patients

Safety and efficacy of Kamikihito for the treatment of anxiety and insomnia in castration resistant prostate cancer patients - KAMIKIHITO study for castration resistant prostate cancer patients

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022547

Enrollment

Registered

2016-06-02

Start date

2016-06-02

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

Anxiety insomnia and fatigue induced by hormone therapy

Interventions

Administration of kamikihito

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Castration resistant prostate cancer patients under hormone therapy with anxiety and insomnia.

Exclusion criteria

Exclusion criteria: 1)Heart disease 2)Severely lung disease 3)Cranial nerve disease with unconsciousness 4)Liver disease more than grade 2 5) Severely drug hypersensitivity 6)Kampo administration within 2 weeks 7) Not appropriate for the study at the physician's assessment

Design outcomes

Primary

Measure	Time frame
Effect of kamikihito on anxiety and insomnia at pre, 4 weeks, 8 weeks and 12 weeks by questionnaire.	—

Secondary

Measure	Time frame
Effect of kamikihito on fatugue at pre, 4 weeks, 8 weeks and 12 weeks by questionnaire and objective evaluation.	—

Countries

Japan

Contacts

Public ContactSatoshi Tamada

Osaka City University Urology

s-tamada@med.osaka-cu.ac.jp06-6645-3857

Outcome results

None listed

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