search
Back to results

Therapeutic Study of Prostatitis With Elevated PSA

Primary Purpose

Prostatitis, PSA

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Huange capsule
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventional treatment group

Conventional treatment group combined with Huange capsule

Arm Description

Routine treatment protocol are used base on clinical guidelines

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

Outcomes

Primary Outcome Measures

Serum PSA
International prostate symptom score

Secondary Outcome Measures

Full Information

First Posted
February 8, 2023
Last Updated
February 8, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
search

1. Study Identification

Unique Protocol Identification Number
NCT05732441
Brief Title
Therapeutic Study of Prostatitis With Elevated PSA
Official Title
A Randomized Controlled Clinical Trial of a Plant Drug (HuangE Capsule) in the Treatment of Patients With Elevated Psa Prostatitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatitis, PSA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1.Conventional treatment group 2. Conventional treatment group combined with Huange capsule
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional treatment group
Arm Type
No Intervention
Arm Description
Routine treatment protocol are used base on clinical guidelines
Arm Title
Conventional treatment group combined with Huange capsule
Arm Type
Experimental
Arm Description
Based on the clinical guidelines, the routine treatment was used in addition to Huange Capsule.
Intervention Type
Drug
Intervention Name(s)
Huange capsule
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serum PSA
Time Frame
4 weeks
Title
International prostate symptom score
Time Frame
4 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Therapeutic Study of Prostatitis With Elevated PSA

We'll reach out to this number within 24 hrs