A clinical trial on the efficacy and safety of concentrated black tomato pulp for the treatment of benign prostatic hyperplasia

Concentrated black tomato pulp consumption for the treatment of benign prostatic hyperplasia: A randomized, open-label, placebo- and tamsulosin-controlled clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800014750

Enrollment

Unknown

Registered

2018-02-02

Start date

2018-03-01

Completion date

Unknown

Last updated

2018-02-05

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

Conditions

benign prostatic hyperplasia

Interventions

Group A:Concentrated black tomato pulp 70 g, orally take three times a day for three months

Group B:Placebo 70 g, orally take three times a day for three months

Group C:Tamsulosin (Harnal) 0.2mg, orally take once daily for three months

Eligibility

Sex/Gender

Male

Age

50 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. men aged = 50 years; 2. with International Prostatic Symptom Score (IPSS) total symptom score of 8 or higher; 3. maximum urinary flow rate (Qmax) of 4 - 15 mL/s with a voided volume of = 100 mL; 4. prostate volume (assessed by transrectal ultrasonography/TRUS) of 20 - 40 mL; 5. postvoid residual urine volume of < 100 mL.

Exclusion criteria

Exclusion criteria: 1. patients with concomitant urological diseases, such as bladder cancer, neurogenic bladder, bladder neck sclerosis, urethral stricture, severe vesical diverticulum, urinary tract infection and so on; 2. diagnosed or suspected prostate cancer; 3. previous prostate surgery or invasive BPH treatments; 4. history of acute urinary retention within 3 months prior to this study; 5. history of severe cardiovascular disorders or pulmonary diseases, orthostatic hypotension, severe hepatic or renal dysfunction, insulin-dependent diabetes; 6. patients with senile dementia or other neurological or mental disorders; 7. known hypersensitivity to a1-blockers or tomato products; 8. patients taking concomitant medications that might alter voiding patterns.

Design outcomes

Primary

Measure	Time frame
International Prostatic Symptom Score (IPSS) total symptom score and quality-of-life (QoL) score;Maximum urinary flow rate (Qmax);	—

Secondary

Measure	Time frame
Serum prostate specific antigen (PSA) level;Prostate volume (assessed by transrectal ultrasonography/TRUS);Postvoid residual urine volume;	—

Countries

China

Contacts

Public ContactZhiping Wang

Institute of Urology, Lanzhou University Second Hospital

erywzp@lzu.edu.cn+86 0931-8942120

Outcome results

None listed

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