ProstatitisNCT05732441
Therapeutic Study of Prostatitis With Elevated PSA
A study testing Huange capsule in people with Prostatitis and PSA, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostatitis, PSA
- What is being tested?
- Huange capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310000
About this study
Official title: 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:
- 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.
- Conditions
- Prostatitis, PSA
- Being tested
- Huange capsule
- Medical subject headings
- Prostatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huange capsuleDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Huange capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum PSA
Measured: 4 weeks
International prostate symptom score
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 Aug 2022
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProstatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1.Conventional treatment group 2. Conventional treatment group combined with Huange capsule
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732441
- Sponsor's protocol ID
- 2022-0354
- Status last verified
- Jul 2022
- First submitted
- 8 Feb 2023
- Last updated
- 17 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial of a Plant Drug (HuangE Capsule) in the Treatment of Patients With Elevated Psa Prostatitis
- ClinicalTrials.gov ID
- NCT05732441
- Acronym / sponsor ID
- 2022-0354
- Conditions
- Prostatitis, PSA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 1.Conventional treatment group 2. Conventional treatment group combined with Huange capsule
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment group | No intervention | –Routine treatment protocol are used base on clinical guidelines |
| Conventional treatment group combined with Huange capsule | Experimental | Drug: Huange capsuleBased on the clinical guidelines, the routine treatment was used in addition to Huange Capsule. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Huange capsuleHuange 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. | Drug | Conventional treatment group combined with Huange capsule |
Primary outcome
Serum PSA
Time frame: 4 weeks
International prostate symptom score
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Huange capsule in people with Prostatitis and PSA, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum PSA (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.