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Status unknownNCT05732441Updated Feb 17, 2023

Therapeutic Study of Prostatitis With Elevated PSA

An interventional study of Huange capsule in Prostatitis and PSA, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-17.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Aug 2022, registered Feb 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Male
01

Study 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.
02

Conditions studied

  • Prostatitis
  • PSA

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03

In context

Prostatitis

88 studies on the registry are indexed under Prostatitis; 11 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 73 interventional studies indexed under Prostatitis.

Browse Prostatitis studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.

Browse Second Affiliated Hospital, School of Medicine, Zhejiang University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form.

Exclusion criteria

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, diabetes mellitus, or diabetic neuropathy and psychosis;
  9. Patients with serum t-PSA>10ng/ml.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • 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

Interventions

  • DrugHuange 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.

06

What researchers measure

Primary outcomes

  1. Serum PSA

    Time frame: 4 weeks

  2. International prostate symptom score

    Time frame: 4 weeks

07

Study locations

1 site
  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
    Hangzhou, Zhejiang 310000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2022 (actual). Primary completion is estimated for Oct 2024, 26 months after the start.

Of 21 interventional studies with no phase under Prostatitis, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 25. This study's planned 26 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 8, 2023
First posted
Feb 17, 2023
StartActual
Aug 1, 2022
Primary completionEst.
Oct 31, 2024
CompletionEst.
Dec 31, 2024
Last update
Feb 17, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05732441
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Feb 17, 2023
Start date
Aug 1, 2022
Primary completion
Oct 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Feb 17, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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