Therapeutic Study of Prostatitis With Elevated PSA

Not Applicable

Active, not recruiting

• Conditions: Prostatitis; PSA
• Interventions: Drug: Huange capsule

• Registration Number: NCT05732441
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-07
• Study Start: 2022-08-01
• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-08
• Last Update Submitted: 2023-02-08
• Study First Posted: 2023-02-17
• Last Update Posted: 2023-02-17
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional treatment group combined with Huange capsule	Huange capsule	Based on the clinical guidelines, the routine treatment was used in addition to Huange Capsule.

Primary Outcome Measures

Name	Time	Method
Serum PSA	4 weeks
International prostate symptom score	4 weeks

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China; 🇨🇳 Hangzhou, Zhejiang, China