Therapeutic Study of Prostatitis With Elevated PSA

NCT ID: NCT05732441

Last Updated: 2023-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2024-12-31

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.

Conditions

Prostatitis; PSA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conventional treatment group

Routine treatment protocol are used base on clinical guidelines

Group Type: NO_INTERVENTION

No interventions assigned to this group

Conventional treatment group combined with Huange capsule

Based on the clinical guidelines, the routine treatment was used in addition to Huange Capsule.

Group Type: EXPERIMENTAL

Huange capsule

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2022-0354

Identifier Type: -

Identifier Source: org_study_id