Therapeutic Study of Prostatitis With Elevated PSA

Study Overview
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Brief Summary
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This clinical study was mainly aimed at exploring the efficacy of herbal medicine (Huange Capsule) in the treatment of patients with prostatitis with elevated PSA. The main questions it aims to answer are: To evaluate the influence and exact curative effect of huange capsule on serum PSA level of patients with PSA-elevated prostatitis, to improve the specificity of PSA and reduce unnecessary puncture biopsy. To provide evidence-based evidence for clinical efficacy evaluation Subjects will be randomized to a routine regimen with or without the use of Huangge capsules. To evaluate whether the efficacy of the conventional treatment combined with Huange capsule group was superior to that of the conventional medication group.

Official Title
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A Randomized Controlled Clinical Trial of a Plant Drug (HuangE Capsule) in the Treatment of Patients With Elevated Psa Prostatitis

Conditions
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Prostatitis, PSA

Intervention / Treatment
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* Drug: Huange capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Compliant with the diagnostic criteria of both Chinese and western medicine for prostatitis; Serum PSA increases, ranging from 4 ng/mL to 10 ng/mL; Male, aged between 18 and 80 years old: B-ultrasound and imaging examination fail to consider the front row cancer; I have not taken any Chinese or western medicine for the treatment of prostatitis in the past two weeks; Those who have signed the informed consent form. Exclusion Criteria: Patients with frequent micturition caused by combined sexually transmitted diseases and urinary tract infection; oliguria or anuria caused by urinary calculi, prostate cancer, and acute and chronic renal failure; Dysuria caused by neurogenic bladder collapse, bladder neck collapse fibrosis, and urethral stricture; the residual urine volume > 150ml: Losers of invasive treatment of benign prostatic obstruction; Patients with pelvic surgery or injury history that affected the local internal organs, muscles, nerves and other functional states; B-ultrasound shows obvious bladder diverticulum or upper urinary tract obstruction caused by BPH, with impaired renal function; Patients with severe primary diseases such as cardiovascular and cerebrovascular diseases, liver and hematopoietic system, refractory diabetes mellitus, or diabetic neuropathy and psychosis; Patients with serum t-PSA>10ng/ml.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1.Conventional treatment group 2. Conventional treatment group combined with Huange capsule
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional treatment group<br>Routine treatment protocol are used base on clinical guidelines | |
| Experimental: Conventional treatment group combined with Huange capsule<br>Based on the clinical guidelines, the routine treatment was used in addition to Huange Capsule. | Drug: Huange capsule<br>* Huange Capsule was orally administered (Zhejiang Kangenbe Pharmaceutical Co., Ltd., specification: 0.4g×60 tablets/bottle, GuoYaoZhunZi Z20110006). Administration method: 1.6g each time, three times a day, 40min after breakfast, lunch and dinner. The treatment course was four weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum PSA |  | 4 weeks | 
| International prostate symptom score |  | 4 weeks |