Chronic ProstatitisPhase 4NCT05890235

Efficacy and Safety of Ningmitai Capsule in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome

A Phase 4 study testing Ningmitai Capsule and Tamsulosin Hydrochloride in people with Chronic Prostatitis, run by Xintian Pharmaceutical at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

1. Clinical trial title：Efficacy and safety of Ningmitai capsule in patients with Chronic Prostatitis/Chronic Pelvic Pain Syndrome：A prospective, randomized, positive drug-controlled, multicenter clinical study 2. Version number/date：1.0 /2018-6-24 3. Principal investigator：Zhang Xiansheng 4. Read more about this study

Who is it for?: Ages 18 to 60 years, men only
Conditions the study is for: Chronic Prostatitis
What is being tested?: Ningmitai Capsule and Tamsulosin Hydrochloride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 323 participants
Where: 1 siteChina
Study dates: 16 Nov 2018to 10 Jul 2022
Phase: Phase 4
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 60 years
Men only
No healthy volunteers
Adult

Who may be able to join

Aged 18-60 years old male patients;
Patients with long-term, repeated pelvic discomfort or pain (NIH-CPSI pain score 4), lasting more than 3 months, may be accompanied by varying degrees of voiding symptoms and sexual dysfunction.
Clinical diagnosis: type III prostatitis.

Who cannot join

Use of any antibiotics and 1 receptor blockers in the past two weeks;
Suffering from seminal vesiculitis, epididymitis, varicocele and prostate, bladder, urethra and other tumors and other diseases affecting bladder function;
Have received TURP, TUIP, internal cystotomy, transurethral hyperthermia/radiofrequency ablation/balloon dilatation, open prostatectomy, or any other prostate surgery and treatment, such as cryotherapy or hyperthermia;
Patients with severe cardiovascular and cerebrovascular, liver, kidney and hematopoietic system diseases and mental illness;
Known to be allergic to Ningmitai capsule or some of its components;
Involuntary, unable to cooperate with the completion of the study.

Trial locations and contacts

1 site in 1 country.

China1 site

The first affiliated hospital of Anhui medical university
Hefei, Anhui

Other trials in China

About this study

Official title: Efficacy and Safety of Ningmitai Capsule in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome：A Prospective, Randomized, Positive Drug-controlled, Multicenter Clinical Study

Clinical trial title：Efficacy and safety of Ningmitai capsule in patients with Chronic Prostatitis/Chronic Pelvic Pain Syndrome：A prospective, randomized, positive drug-controlled, multicenter clinical study
Version number/date：1.0 /2018-6-24
Principal investigator：Zhang Xiansheng
Main research units：The first affiliated hospital of Anhui medical university clinical medical research ethics committee
Clinical trial start and end dates：2018-10-1-2022-12-31
Objective: To observe whether Ningmitai capsule(NMT) alone or combined with Tamsulosin for 8 weeks is more effective than Tamsulosin in improving symptoms of CP/CPPS .
Study type:Interventional study
Total sample size:300
Inclusion criteria: ① Age: male patients aged 18-60 years; ② Long-term and repeated pelvic discomfort or pain (NIH-CPSI pain score ≥ 4 points), lasting more than 3 months, may be accompanied by different degrees of urination symptoms and sexual dysfunction; ③ Diagnosed as type III prostatitis. Exclusion criteria:

Use any antibiotics and α1 receptor blockers in the past two weeks; ② Suffering from seminal vesiculitis, epididymitis, varicocele, tumors in prostate, bladder and urethra and other diseases affecting bladder function;
Have received transurethral resection of the prostate(TURP), transurethral incision of the prostate (TUIP), bladder neck incision, transurethral hyperthermia/radiofrequency ablation/balloon dilatation, open prostatectomy, or any other prostate surgery and treatment, such as cryotherapy;
Patients with severe cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic diseases and psychosis; ⑤ Patients who are allergic to NMT or some of its components; ⑥ Patients who are involuntarily unable to cooperate with the completion of the test.

Interventions:
NMT group Oral Ningmitai capsule, 0.38 g/capsule, tid, 4 capsules each time, after meals, for 8 weeks.

Sample size:100 2. Tamsulosin group Tamsulosin Hydrochloride Sustained-release Capsules were orally administered at 0.2 mg/capsule, once daily, 1 capsule each time, for 8 weeks.

Sample size:100 3.Combination group Oral Ningmitai capsule, 0.38 g/capsule, tid, 4 capsules each time, after meals, for 8 weeks.Tamsulosin Hydrochloride Sustained-release Capsules were orally administered at 0.2 mg/capsule, once daily, 1 capsule each time, for 8 weeks.

Sample size:100

Read the detailed description

Clinical trial title：Efficacy and safety of Ningmitai capsule in patients with Chronic Prostatitis/Chronic Pelvic Pain Syndrome：A prospective, randomized, positive drug-controlled, multicenter clinical study
Version number/date：1.0 /2018-6-24
Principal investigator：Zhang Xiansheng
Main research units：The first affiliated hospital of Anhui medical university clinical medical research ethics committee
Clinical trial start and end dates：2018-10-1-2022-12-31
Objective: To observe whether Ningmitai capsule(NMT) alone or combined with Tamsulosin for 8 weeks is more effective than Tamsulosin in improving symptoms of CP/CPPS .
Study type:Interventional study
Total sample size:300
Interventions:
NMT group Oral Ningmitai capsule, 0.38 g/capsule, tid, 4 capsules each time, after meals, for 8 weeks.

Sample size:100 2. Tamsulosin group Tamsulosin Hydrochloride Sustained-release Capsules were orally administered at 0.2 mg/capsule, once daily, 1 capsule each time, for 8 weeks.

Sample size:100

10、Treatment cycle：8 weeks. the trial treatment began on the day of randomization.

11、Visiting nodes：① before treatment (-2 weeks to 0 days), ②4 weeks of treatment (28 ± 10 days), ③ 8 weeks of treatment (56 ± 14 days).

12、Countries of recruitment and research settings: Country:China Province:Anhui Institution(hospital):The first affiliated hospital of Anhui medical university Level of the institution:Tertiary A

13、Recruiting status:Completed Participant age:18 years Participant age:60 years Gender: Male

14、Randomization Procedure:In this study, the research center was used as the stratification factoror random assignment. Subjects were randomly assigned (1:1:1) to Tamsulosin group, NMT group and combination group according to the random allocation table (subject random code) simulated by SAS 9.2 software. Subjects' random numbers cannot be reused by other subjects, whether they are using the study drug or not, or the study is terminated for any reason.

15、Sign the informed consent: Yes

16、Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:In this study, case report form (CRF) was used to collect and manage research data. The sponsor or designated person is responsible for data management of the study, including data quality control. The workflow of data management includes data entry, data verification and query, medical coding, data audit, database locking, data export and transmission, data and data management file archiving, etc.

Conditions: Chronic Prostatitis
Being tested: Ningmitai Capsule, Tamsulosin Hydrochloride

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ningmitai CapsuleDrug
Also called Ningmitai
Ningmitai Capsule (Ningmitai®) is Traditional Chinese Medicine which has already used in treatment of urinary system disease (eg. CPPS, BPH) in China for more than twenty years. The instruction of Ningmitai Capsule is 0.38g/capsule, 4 capsule/time, tid.
Tamsulosin HydrochlorideDrug
Also called Tamsulosin
Tamsulosin is α1A-adrenergic receptor which has used in treatment of BPH for few years. The instruction of Tamsulosin Capsule is 1 tablet at a time, 1 time a day.

Study groups in NCT05890235
Study group	Role	What they receive
Ningmitai Capsule group	Experimental	Patients take Ningmitai capsule, 0.38 g/capsule, tid, 4 capsules each time, after meals, for 8 weeks. Receives: Drug: Ningmitai Capsule
Tamsulosin Hydrochloride Sustained-release Capsules group	Active comparator	Patients take Tamsulosin Hydrochloride Sustained-release Capsules ,0.2 mg/capsule, once daily, 1 capsule each time, for 8 weeks. Receives: Drug: Tamsulosin Hydrochloride
Combined group	Active comparator	Patients take Ningmitai capsule, 0.38 g/capsule, tid, 4 capsules each time, after meals, for 8 weeks and Tamsulosin Hydrochloride Sustained-release Capsules ,0.2 mg/capsule, once daily, 1 capsule each time, for 8 weeks. Receives: Drug: Ningmitai Capsule; Drug: Tamsulosin Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

The National Institutes of Health chronic prostatitis symptom index total score
the change of NIH-CPSI total score from baseline to 8 weeks. National Institutions of Health Chronic Prostatitis Symptom Index（NIH-CPSI，0~43 points） consists of three subscales. The first part is pain symptoms, which consists of questions 1~4 (0~21 points), and evaluates the location, frequency and severity of pain. The second part is urination symptoms, which consists of questions 5~6 (0 ~ 10 points), and evaluates the severity of incomplete urination and frequent urination; The third part is to evaluate the impact on the quality of life, which consists of questions 7~9 (0~12 points).The higher the score, the more serious the symptoms of chronic prostatitis.
Measured: Treatment for 8 weeks

Secondary outcomes (3)

NIH-CPSI total score, pain score, urinary score and quality of life score
The changes of NIH-CPSI total score, pain score, urinary score and quality of life score from baseline to 4 weeks; National Institutions of Health Chronic Prostatitis Symptom Index（NIH-CPSI，0~43 points） consists of three subscales. The first part is pain symptoms, which consists of questions 1~4 (0~21 points), and evaluates the location, frequency and severity of pain. The second part is urination symptoms, which consists of questions 5~6 (0 ~ 10 points), and evaluates the severity of incomplete urination and frequent urination; The third part is to evaluate the impact on the quality of life, which consists of questions 7~9 (0~12 points).The higher the score, the more serious the symptoms of chronic prostatitis.
Measured: Treatment for 4 weeks
NIH-CPSI total score, pain score, urinary score and quality of life score
The changes of NIH-CPSI pain score, urinary score and quality of life score from baseline to 8 weeks; National Institutions of Health Chronic Prostatitis Symptom Index（NIH-CPSI，0~43 points） consists of three subscales. The first part is pain symptoms, which consists of questions 1~4 (0~21 points), and evaluates the location, frequency and severity of pain. The second part is urination symptoms, which consists of questions 5~6 (0 ~ 10 points), and evaluates the severity of incomplete urination and frequent urination; The third part is to evaluate the impact on the quality of life, which consists of questions 7~9 (0~12 points).The higher the score, the more serious the symptoms of chronic prostatitis.
Measured: Treatment for 8 weeks
Response rate
The response rate is defined as a decrease of at least 25% in the NIH-CPSI total score and pain score, respectively
Measured: Treatment for 4 & 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Nov 201810 Jul 2022

First posted6 Jun 2023
Study start16 Nov 2018
Primary completion10 Jul 2022
Study completion10 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 323 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05890235
Sponsor's protocol ID: NMT18016S
Status last verified: May 2023
First submitted: 23 May 2023
Last updated: 6 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Gao J, Zhang Y, Du J, Liu Q, Cheng Y, Yang W, Wang D, Wang W, Zheng L, Wang D, Wu L, Jiang X, Men Q, Liang C, Zhang X. Ningmitai capsule in patients with chronic prostatitis/chronic pelvic pain syndrome: a multicenter, prospective, randomized, parallel, positive-controlled study. Front Pharmacol. 2025 Dec 3;16:1667819. doi: 10.3389/fphar.2025.1667819. eCollection 2025.
PubMed 41415574

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Prostatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Ningmitai Capsule in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome：A Prospective, Randomized, Positive Drug-controlled, Multicenter Clinical Study
ClinicalTrials.gov ID: NCT05890235
Acronym / sponsor ID: NMT18016S
Conditions: Chronic Prostatitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 323 participants (actual)
Lead sponsor: Xintian PharmaceuticalIndustry (pharma, biotech, devices)
Study start: 16 Nov 2018 (actual)
Primary completion: 10 Jul 2022 (actual)
Study completion: 10 Jul 2022 (actual)
First posted: 6 Jun 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.

Clinical trial title：Efficacy and safety of Ningmitai capsule in patients with Chronic Prostatitis/Chronic Pelvic Pain Syndrome：A prospective, randomized, positive drug-controlled, multicenter clinical study
Version number/date：1.0 /2018-6-24
Principal investigator：Zhang Xiansheng
Main research units：The first affiliated hospital of Anhui medical university clinical medical research ethics committee
Clinical trial start and end dates：2018-10-1-2022-12-31
Objective: To observe whether Ningmitai capsule(NMT) alone or combined with Tamsulosin for 8 weeks is more effective than Tamsulosin in improving symptoms of CP/CPPS .
Study type:Interventional study
Total sample size:300
Inclusion criteria: ① Age: male patients aged 18-60 years; ② Long-term and repeated pelvic discomfort or pain (NIH-CPSI pain score ≥ 4 points), lasting more than 3 months, may be accompanied by different degrees of urination symptoms and sexual dysfunction; ③ Diagnosed as type III prostatitis. Exclusion criteria:

Use any antibiotics and α1 receptor blockers in the past two weeks; ② Suffering from seminal vesiculitis, epididymitis, varicocele, tumors in prostate, bladder and urethra and other diseases affecting bladder function;
Have received transurethral resection of the prostate(TURP), transurethral incision of the prostate (TUIP), bladder neck incision, transurethral hyperthermia/radiofrequency ablation/balloon dilatation, open prostatectomy, or any other prostate surgery and treatment, such as cryotherapy;
Patients with severe cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic diseases and psychosis; ⑤ Patients who are allergic to NMT or some of its components; ⑥ Patients who are involuntarily unable to cooperate with the completion of the test.

Interventions:
NMT group Oral Ningmitai capsule, 0.38 g/capsule, tid, 4 capsules each time, after meals, for 8 weeks.

Sample size:100 2. Tamsulosin group Tamsulosin Hydrochloride Sustained-release Capsules were orally administered at 0.2 mg/capsule, once daily, 1 capsule each time, for 8 weeks.

Sample size:100

Detailed description

Clinical trial title：Efficacy and safety of Ningmitai capsule in patients with Chronic Prostatitis/Chronic Pelvic Pain Syndrome：A prospective, randomized, positive drug-controlled, multicenter clinical study
Version number/date：1.0 /2018-6-24
Principal investigator：Zhang Xiansheng
Main research units：The first affiliated hospital of Anhui medical university clinical medical research ethics committee
Clinical trial start and end dates：2018-10-1-2022-12-31
Objective: To observe whether Ningmitai capsule(NMT) alone or combined with Tamsulosin for 8 weeks is more effective than Tamsulosin in improving symptoms of CP/CPPS .
Study type:Interventional study
Total sample size:300
Interventions:
NMT group Oral Ningmitai capsule, 0.38 g/capsule, tid, 4 capsules each time, after meals, for 8 weeks.

Sample size:100 2. Tamsulosin group Tamsulosin Hydrochloride Sustained-release Capsules were orally administered at 0.2 mg/capsule, once daily, 1 capsule each time, for 8 weeks.

Sample size:100

10、Treatment cycle：8 weeks. the trial treatment began on the day of randomization.

11、Visiting nodes：① before treatment (-2 weeks to 0 days), ②4 weeks of treatment (28 ± 10 days), ③ 8 weeks of treatment (56 ± 14 days).

12、Countries of recruitment and research settings: Country:China Province:Anhui Institution(hospital):The first affiliated hospital of Anhui medical university Level of the institution:Tertiary A

13、Recruiting status:Completed Participant age:18 years Participant age:60 years Gender: Male

15、Sign the informed consent: Yes

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Ningmitai Capsule group	Experimental	Drug: Ningmitai CapsulePatients take Ningmitai capsule, 0.38 g/capsule, tid, 4 capsules each time, after meals, for 8 weeks.
Tamsulosin Hydrochloride Sustained-release Capsules group	Active comparator	Drug: Tamsulosin HydrochloridePatients take Tamsulosin Hydrochloride Sustained-release Capsules ,0.2 mg/capsule, once daily, 1 capsule each time, for 8 weeks.
Combined group	Active comparator	Drug: Ningmitai Capsule, Drug: Tamsulosin HydrochloridePatients take Ningmitai capsule, 0.38 g/capsule, tid, 4 capsules each time, after meals, for 8 weeks and Tamsulosin Hydrochloride Sustained-release Capsules ,0.2 mg/capsule, once daily, 1 capsule each time, for 8 weeks.

Who may qualify

Ages: 18 to 60 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Aged 18-60 years old male patients;
Patients with long-term, repeated pelvic discomfort or pain (NIH-CPSI pain score 4), lasting more than 3 months, may be accompanied by varying degrees of voiding symptoms and sexual dysfunction.
Clinical diagnosis: type III prostatitis.

Key exclusion criteria (6 listed)

Use of any antibiotics and 1 receptor blockers in the past two weeks;
Suffering from seminal vesiculitis, epididymitis, varicocele and prostate, bladder, urethra and other tumors and other diseases affecting bladder function;
Have received TURP, TUIP, internal cystotomy, transurethral hyperthermia/radiofrequency ablation/balloon dilatation, open prostatectomy, or any other prostate surgery and treatment, such as cryotherapy or hyperthermia;
Patients with severe cardiovascular and cerebrovascular, liver, kidney and hematopoietic system diseases and mental illness;
Known to be allergic to Ningmitai capsule or some of its components;

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
Ningmitai CapsuleAlso: NingmitaiNingmitai Capsule (Ningmitai®) is Traditional Chinese Medicine which has already used in treatment of urinary system disease (eg. CPPS, BPH) in China for more than twenty years. The instruction of Ningmitai Capsule is 0.38g/capsule, 4 capsule/time, tid.	Drug	Combined group, Ningmitai Capsule group
Tamsulosin HydrochlorideAlso: TamsulosinTamsulosin is α1A-adrenergic receptor which has used in treatment of BPH for few years. The instruction of Tamsulosin Capsule is 1 tablet at a time, 1 time a day.	Drug	Combined group, Tamsulosin Hydrochloride Sustained-release Capsules group

Primary outcome

The National Institutes of Health chronic prostatitis symptom index total score
Time frame: Treatment for 8 weeks
the change of NIH-CPSI total score from baseline to 8 weeks. National Institutions of Health Chronic Prostatitis Symptom Index（NIH-CPSI，0~43 points） consists of three subscales. The first part is pain symptoms, which consists of questions 1~4 (0~21 points), and evaluates the location, frequency and severity of pain. The second part is urination symptoms, which consists of questions 5~6 (0 ~ 10 points), and evaluates the severity of incomplete urination and frequent urination; The third part is to evaluate the impact on the quality of life, which consists of questions 7~9 (0~12 points).The higher the score, the more serious the symptoms of chronic prostatitis.

3 secondary outcomes

NIH-CPSI total score, pain score, urinary score and quality of life score
Time frame: Treatment for 4 weeks
NIH-CPSI total score, pain score, urinary score and quality of life score
Time frame: Treatment for 8 weeks
Response rate
Time frame: Treatment for 4 & 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
Derived from this study: PubMed 41415574Gao J, Zhang Y, Du J, Liu Q, Cheng Y, Yang W, Wang D, Wang W, Zheng L, Wang D, Wu L, Jiang X, Men Q, Liang C, Zhang X. Ningmitai capsule in patients with chronic prostatitis/chronic pelvic pain syndrome: a multicenter, prospective, randomized, parallel, positive-controlled study. Front Pharmacol. 2025 Dec 3;16:1667819. doi: 10.3389/fphar.2025.1667819. eCollection 2025.
Individual participant dataSharing planned: No

Related trials for Chronic Prostatitis

Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Enrolling by invitation
Pulsed Electromagnetic Versus Hydrotherapy on Chronic Pelvic Pain
Chronic Pelvic Pain Syndrome
Recruiting
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
Erectile Dysfunction Due to Arterial Insufficiency, Erectile Dysfunction
RecruitingObservational study
Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
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Recruiting
Oxiblume:CoQ10 (Ralivia) Therapy for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
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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.

Zhongguo Chen, MD study chair

employee

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ningmitai Capsule and Tamsulosin Hydrochloride in people with Chronic Prostatitis, run by Xintian Pharmaceutical 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 6 Jun 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The National Institutes of Health chronic prostatitis symptom index total score (time frame: Treatment for 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05890235, which also lists 1 linked publication.

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 6 Jun 2023.