Clinical trial NCT05732441: Therapeutic Study of Prostatitis With Elevated PSA
Official title: A Randomized Controlled Clinical Trial of a Plant Drug (HuangE Capsule) in the Treatment of Patients With Elevated Psa Prostatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostatitis
PSA
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1.Conventional treatment group 2. Conventional treatment group combined with Huange capsule
Primary purpose: TREATMENT

Brief summary: 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:

1. 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.
2. 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.


Eligibility criteria: Inclusion Criteria:

1. Compliant with the diagnostic criteria of both Chinese and western medicine for prostatitis;
2. Serum PSA increases, ranging from 4 ng/mL to 10 ng/mL;
3. Male, aged between 18 and 80 years old:
4. B-ultrasound and imaging examination fail to consider the front row cancer;
5. I have not taken any Chinese or western medicine for the treatment of prostatitis in the past two weeks;
6. Those who have signed the informed consent form.

Exclusion Criteria:

1. Patients with frequent micturition caused by combined sexually transmitted diseases and urinary tract infection;
2. oliguria or anuria caused by urinary calculi, prostate cancer, and acute and chronic renal failure;
3. Dysuria caused by neurogenic bladder collapse, bladder neck collapse fibrosis, and urethral stricture;
4. the residual urine volume \> 150ml:
5. Losers of invasive treatment of benign prostatic obstruction;
6. Patients with pelvic surgery or injury history that affected the local internal organs, muscles, nerves and other functional states;
7. B-ultrasound shows obvious bladder diverticulum or upper urinary tract obstruction caused by BPH, with impaired renal function;
8. Patients with severe primary diseases such as cardiovascular and cerebrovascular diseases, liver and hematopoietic system, refractory diabetes mellitus, or diabetic neuropathy and psychosis;
9. Patients with serum t-PSA\>10ng/ml.

Primary outcomes:
measure: Serum PSA
timeFrame: 4 weeks
measure: International prostate symptom score
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
References: