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An evidence-based evaluation of Jianpi Yishen prescription in the intervention of cancer-induced fatigue in hormone-sensitive prostate cancer patients after androgen deprivation

An evidence-based evaluation of Jianpi Yishen prescription in the intervention of cancer-induced fatigue in hormone-sensitive prostate cancer patients after androgen deprivation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000564
Enrollment
Unknown
Registered
2024-10-15
Start date
2024-11-10
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Cancer fatigue after androgen deprivation in prostate cancer

Interventions

Treatment group:Jianpi Yishenfang granules
Control group:Jianpi Yishen prescription placebo

Sponsors

Xiyuan Hospital China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
45 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Men aged 45 years and above and under 80 years; (2) Pathological or clinically confirmed HSPC; (3) During the ADT treatment period; 1) The stage of prostate cancer is T2 T3N0M0 T3N0M1 T3N1M0 T3N1M1 and above. 2) Testosterone reaches castration level below 50mg/ml. (4) Have CRF symptoms; (5) TCM syndrome differentiation is spleen and kidney deficiency syndrome; (6) No Chinese or Western drugs used to treat CRF have been used in the past two weeks; (7) Sign informed consent and take the test voluntarily.

Exclusion criteria

Exclusion criteria: (1) Combined with mental abnormality or cognitive dysfunction; (2) Patients who have allergies to the study drug or other recent drugs that may interfere with the study results; (3) serious diseases and dysfunction of major organs such as liver kidney and heart; (4) Malignant tumors of other tissues and organs; (5) Patients within 6 weeks after surgery; (6) Patients who are receiving radiation therapy or within 2 months after the end of radiation therapy; (7) Patients who are receiving chemotherapy or within 2 months after the end of chemotherapy; (8) Other clinical trials within the past 3 months.

Design outcomes

Primary

MeasureTime frame
Piper Fatigue Scale score;CRF core indicator set;

Secondary

MeasureTime frame
TCM syndrome integral;IL-6;T lymphocyte subsets (CD4+/CD8+ CD8+ CD4+ CD3+);psa;AMS;NK;FACT-F;T;PTN;

Countries

china

Contacts

Public Contactgao zhan

Xiyuan Hospital China Academy of Chinese Medical Sciences

gaozhanmd@vip.163.com13910871852

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026