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Efficacy and Safety of Chinese Medicine Nanbei Decoction Combined With Androgen Blockade in The Treatment of Advanced Prostate Cancer: a Randomized, Double-Blind, Placebo-Controlled Clinical Study

Phase 1
Recruiting
Conditions
Advanced Prostate Cancer
Registration Number
ITMCTR2000004034
Lead Sponsor
Department of Urology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Male
Target Recruitment
Not specified
Inclusion Criteria

(1) It is in accordance with the diagnostic standard of Western medicine for advanced prostate cancer.
(2) It is in accordance with the TCM diagnostic standard of Qi and yin deficiency syndrome.
(3) In the stage of maximal androgen blockade treatment;
(4) Sign informed consent.

Exclusion Criteria

(1) Hepatitis A, hepatitis B, hepatitis C and other infectious diseases;
(2) Abdominal ultrasound showed obstructive disease, abdominal CT showed liver metastasis;
(3) Liver function is not complete;
(4) Severe cardiovascular and cerebrovascular diseases, renal insufficiency and mental history;
(5) Primary malignant tumor, except prostate cancer.
(6) In recent 3 months, he has taken other drugs (including traditional Chinese Medicine) in addition to anti male treatment.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Quality of life FACT-P score;PSA response time;Evaluation of tumor focus;
Secondary Outcome Measures
NameTimeMethod
TCM syndrome score;Incidence of anti male reaction;Incidence of castration resistance;
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