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Effect of Saw Palmtto extract in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS): a multicenter, randomized, double-blind, placebo-controlled trial

Effect of Saw Palmtto extract in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS): a multicenter, randomized, double-blind, placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16010196
Enrollment
Unknown
Registered
2016-12-21
Start date
2017-01-01
Completion date
Unknown
Last updated
2020-02-25

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

Conditions

chronic prostatitis/chronic pelvic pain syndrome

Interventions

Sponsors

Peking university First Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Male 18-50 years old; 2. The participants had pelvic area pain or discomfort at least 3 months prior to admission; 3. The NIH-CPSI total scores >10,and pain scores =4; 4. Men with clinically and laboratory diagnosed CP/CPPS; 5. The participants will have sexual desire to live at least in the last 3 months; 6. Signed informed consent; 7. Participants could understand the requirements of this trial.

Exclusion criteria

Exclusion criteria: 1. Urinary tract infection or urine culture positive, clinical diagnosis of urethritis (including urethral mouth secretions, the culture was positive), acute epididymitis patients, patients with suspected prostate cancer; 2. Patients with genital herpes diagnosed or treated within 12 months before admission; 3. Patients with diseases could affect micturition, such as neurogenic bladder dysfunction or urethral stricture; 4. Patients who have history of operation or traumatic, which affect the evaluation of efficacy of the drug; 5. Patients with severe cardiovascular disease, s sexually transmitted diseases (including gonorrhea, chlamydia, mycoplasma or Trichomonas, but does not include any HIV/AIDS), malignant tumor, peptic ulcer, hemorrhage disease; 6. Patients are taking antibiotics, non steroidal anti-inflammatory drugs, alpha receptor blockers, bioflavonoids, Chinese patent medicines and plant drugs for prostatitis; 7. Patients are taking drugs affect function of bladder outlet and sexual; 8. Patients with insufficiency of liver or kidney, AST or ALT more than 1.5 times the upper limit of normal, creatinine more than the upper limit of normal and with clinical significance; 9. Have history of allergic reactions of alcohol ,study drug or similar drugs; 10. Patients with mental diseases, acrasia, alcohol dependence and drug abuse; 11. In three months participated in any other clinical trials, or have birth preparation; 12. Researchers recorgnized anyone who is not suitable to participate in this clinical study of patients.

Design outcomes

Primary

MeasureTime frame
NIH-CPSI;IIEF-5;

Countries

China

Contacts

Public ContactKai Zhang

Peking University First Hospital

kaizhangpku@163.com+86 010-83575100

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 24, 2026