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Therapeutic Study of Prostatitis With Elevated PSA

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05732441
Enrollment
60
Registered
2023-02-17
Start date
2022-08-01
Completion date
2024-12-31
Last updated
2023-02-17

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

Conditions

Prostatitis, PSA

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.

Interventions

DRUGHuange capsule

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.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

1.Conventional treatment group 2. Conventional treatment group combined with Huange capsule

Eligibility

Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Serum PSA4 weeks
International prostate symptom score4 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026