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Randomized Controlled, Double-Blind, Double-Simulated Study on Qianlie Tongluo Decoction in the Treatment of Type III Chronic Nonbacterial Prostatitis with Damp-Heat Stasis Syndrome

Randomized Controlled, Double-Blind, Double-Simulated Study on Qianlie Tongluo Decoction in the Treatment of Type III Chronic Nonbacterial Prostatitis with Damp-Heat Stasis Syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001714
Enrollment
Unknown
Registered
2026-07-09
Start date
2026-07-13
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Type III Prostatitis

Interventions

Treatment group:Oral administration of 1 placebo capsule once daily before bedtime
2 sachets of Qianlie Tongluo formula-free granules twice daily, infused with 200 mL warm boiled water
Control group::Oral administration of 1 Tamsulosin Hydrochloride Capsule once daily before bedtime
2 sachets of placebo herbal granules twice daily, infused with 200 mL warm boiled water

Sponsors

Dongzhimen Hospital, Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: (1) Male patients meeting the Western medicine diagnostic criteria for type III prostatitis; (2) NIH-CPSI score > 10 points; (3) Patients conforming to the syndrome differentiation standard of damp-heat stagnation and blood stasis syndrome; (4) Patients with relevant symptoms consistent with diagnostic criteria lasting for more than 3 months; (5) Aged from 18 to 50 years old (inclusive); (6) No antibiotics or treatments for chronic prostatitis administered within 2 weeks before enrollment; (7) No other medications taken by patients within two weeks prior to enrollment; (8) Patients fully informed of the trial conditions and voluntarily signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients complicated with prostatic tumors, neurogenic bladder dysfunction, urethral malformation or stricture, and severe neurosis. (2) Patients with urinary tract infection or urethritis. (3) For patients presenting mainly with local pain, other diseases involving lower abdomen, perineum, lumbosacral region and other parts shall be excluded, such as ureteral or vesical calculi, inguinal hernia, pubic osteitis, varicocele, epididymitis, colorectal diseases, lumbodorsal fasciitis, etc. (4) Patients complicated with severe primary diseases of cardiovascular and cerebrovascular systems, liver, kidney and hematopoietic system. (5) Subjects participating in other clinical drug trials concurrently or taking drugs with similar therapeutic effects to the trial medication. (6) Patients who use Chinese and Western medicines, health products, or herbal decoctions containing prescribed medicinal slices with therapeutic effects on this disease during the trial period. (7) Patients with fertility requirements.

Design outcomes

Primary

MeasureTime frame
National Institutes of Health Chronic Prostatitis Symptom Index;

Secondary

MeasureTime frame
International Index of Erectile Function-5;Generalized Anxiety Disorder-7;Patient Health Questionnaire-9;Traditional Chinese Medicine Syndrome Score Scale;Routine semen analysis;

Countries

China

Contacts

Public ContactLi Haisong

Dongzhimen Hospital, Beijing University of Chinese Medicine

lihs369@sina.com13601221399

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026