Therapeutic Study of Prostatitis With Elevated PSA

NCT05732441 | Unknown

• 1 other identifier: 2022-0354
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 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. 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

Outcome Measures

Primary Outcomes (2)

• Serum PSA

  4 weeks

• International prostate symptom score

  4 weeks

Study Arms (2)

Conventional treatment group

NO INTERVENTION

Routine treatment protocol are used base on clinical guidelines

Conventional treatment group combined with Huange capsule

EXPERIMENTAL

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

Drug: Huange capsule

Interventions

Huange capsule 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.

Conventional treatment group combined with Huange capsule

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

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

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Prostatitis

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1.Conventional treatment group 2. Conventional treatment group combined with Huange capsule

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 17, 2023
• Study Start: August 1, 2022
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 17, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)