Therapeutic Study of Prostatitis With Elevated PSA

Prostatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05732441
• Other study ID #: 2022-0354
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostatitis
• PSA

Intervention

Drug:
• Huange 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.

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum PSA		4 weeks
Primary	International prostate symptom score		4 weeks