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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostatitis; PSA
• Intervention / Treatment: Drug: Huange capsule

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional treatment group; Routine treatment protocol are used base on clinical guidelines
Experimental: Conventional treatment group combined with Huange capsule; Based on the clinical guidelines, the routine treatment was used in addition to Huange Capsule.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum PSA	4 weeks
International prostate symptom score	4 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Anticipated): October 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Prostatic Diseases; Prostatitis
• Other Study ID Numbers: 2022-0354

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No