Randomized double-blind parallel controlled non inferiority test multicenter phase III clinical trial comparing the efficacy and safety of the new and original prescriptions of Qianlie Tongyu Capsules in the treatment of chronic non bacterial prostatitis type IIIA (blood stasis block with damp heat retention syndrome)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2025000174

Enrollment

Unknown

Registered

2025-01-25

Start date

2024-11-15

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Non Bacterial Prostatitis Type IIIA (Blood Stasis Block with Damp Heat Accumulation Syndrome)

Interventions

Positive control group:The original prescription of Qianlie Tongyu Capsules (including pangolin), taken after meals, 5 capsules/time, 3 times/day, with a treatment period of 1 cycle (28 days)

Test group:New prescription for Qianlie Tongyu Capsules (excluding pangolin) taken after meals 5 capsules/time 3 times/day with a treatment period of 1 cycle (28 days)

Eligibility

Sex/Gender

Male

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1) Male aged 18-50 years old (including boundaries); 2) Meets the diagnostic criteria for type IIIA chronic non bacterial prostatitis in Western medicine; 3) Meets the diagnostic criteria of traditional Chinese medicine for blood stasis obstruction and damp heat retention syndrome; 4) Individuals with symptoms of chronic prostatitis for more than 3 months; 5) The subjects voluntarily participate provide informed consent and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1Allergy to =2 substances or trial drug components. 2Acute/specific prostatitis. 3Unresolved diseases: seminal vesiculitis hematospermia epididymitis prostate issues. 4Prostate cancer/surgery history. 5Unresolved diseases: urethral bladder kidney urinary stone issues. 6Prior prostate/urethral/vas deferens puncture treatment. 7Severe organ system diseases. 8Mental/neurological issues can't complete trial. 9Elevated ALT/creatinine levels. 10Recent prostatitis treatment. 11Recent other clinical trial participation. 12Deemed unsuitable by researchers.

Design outcomes

Primary

Measure	Time frame
Difference in NIH-CPSI scores before and after treatment (on the 28th day of administration);	—

Secondary

Measure	Time frame
Clinical symptoms and efficacy of prostate digital examination and prostate fluid examination (before treatment and on the 28th day of administration);Difference in NIH-CPSI scores before and after treatment (on the 14th day of administration);Prostate massage fluid white blood cell (EPS-WBC) difference (before treatment, on the 28th day of administration);Traditional Chinese Medicine Syndrome Efficacy (before treatment, on the 14th and 28th day of administration);The main single symptom efficacy of traditional Chinese medicine (before treatment, on the 14th and 28th day of administration);	—

Measure

Time frame

Clinical symptoms and efficacy of prostate digital examination and prostate fluid examination (before treatment and on the 28th day of administration);Difference in NIH-CPSI scores before and after treatment (on the 14th day of administration);Prostate massage fluid white blood cell (EPS-WBC) difference (before treatment, on the 28th day of administration);Traditional Chinese Medicine Syndrome Efficacy (before treatment, on the 14th and 28th day of administration);The main single symptom efficacy of traditional Chinese medicine (before treatment, on the 14th and 28th day of administration);

—

Countries

China

Contacts

Public ContactQin Guozheng

Yunnan Provincial Traditional Chinese Medicine Hospital

qin60@tom.com13308808556

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026