Therapeutic Study of Prostatitis With Elevated PSA | NCT05732441

Studies
Therapeutic Study of Prostatitis With Elevated PSA

NCT05732441

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

Feb 17, 2023Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Prostatitis
PSA

Interventions

Huange capsule

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2022Actual

Primary Completion Date

Oct 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Feb 8, 2023

First Submission Date that Met QC Criteria

Feb 8, 2023

First Posted Date

Feb 17, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2023

Last Update Posted Date

Feb 17, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

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

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China		Hangzhou	Zhejiang	310000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases