Clinical Study of Jianpi Yishen Decoction on Intervention of Metabolic Complications of Androgen Deprivation in HSPC Patients
- Conditions
- Metabolic Complications of Androgen Deprivation
- Registration Number
- ITMCTR2200006460
- Lead Sponsor
- Xiyuan Hospital, Chinese Academy of traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- Not specified
(1) Men aged 45 and over and under 80.
(2) HSPC was diagnosed pathologically or clinically.
(3) During ADT treatment.
1) Prostate cancer stage is t3n0mo, t3n0m1, t3nimo, t3nimi and above.
2) Testosterone reached the castration level below 50mg/ml.
3) The patient has clinical symptoms of androgen deficiency syndrome: AMS scale score: = 27 points.
(4) Serum creatinine = 1.5 × ULN (upper limit of normal range), or calculated creatinine clearance rate of 60ml/min.
(5) Liver function serum bilirubin = 1.5 × ULN (except subjects with documented Gilbert syndrome), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) = 2.5 × ULN.
(6) The life expectancy is at least 6 months.
(7) Subjects whose spouses are women of childbearing age must agree to use double protective contraceptives during the study period and within half a year after the last administration, and must not donate sperm.
(8) The subjects (or their legal representatives) sign the informed consent form, indicating that they have understood the purpose of the study and the required procedures, and are willing to participate in the study.
(1) With serious primary cardiovascular disease, liver disease, kidney disease, hematological disease, lung disease, or serious diseases that affect their survival, such as AIDS, the researchers believe that they should not be selected. Alt, AST and bun of liver function exceed 50% of the upper limit of normal value, and Cr of renal function exceeds the upper limit of normal value, which will not be selected.
(2) Active or symptomatic viral hepatitis or chronic liver disease. Consistent infection with human immunodeficiency virus (HIV) and / or hepatitis B virus (detected as positive for hepatitis B surface antigen [hbsag] / or quantitative positive for hepatitis B virus dna[hbv-dna]) or hepatitis C virus (detected as positive for anti hepatitis C virus [hcv] antibody) and / or quantitative positive for hepatitis C virus rna[hcv-rna], and other malignant tumors with a recurrence probability of = 30% in the next 24 months.
(3) According to the judgment of the researcher, there are problems that are inconsistent with the best interests of the subjects participating in the study (such as affecting the happiness of the subjects) or that may hinder, restrict or interfere with the relevant evaluation of the research plan. Note: the researcher should ensure that the subjects meet all the inclusion criteria during the screening period.
(4) Those who do not meet the inclusion criteria, do not use drugs according to the regulations, and cannot judge the curative effect, or incomplete data affect the judgment of curative effect.
(5) Legally disabled patients (blind, deaf, dumb, intellectual disorders), psychotic patients.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AMS scale score;
- Secondary Outcome Measures
Name Time Method Abdominal circumference;PSA;Short fatigue scale score;Fasting blood glucose;blood pressure;body mass index;Epic-26 scale score;Gonadal six levels;blood fat;