Clinical observation of concentrated extract of black tomato on patients with erectile dysfunction

A randomized, open-label, placebo- and Fu fang xuan ju capsule-controlled clinical trial of black tomato concentrate extract for the treatment of erectile dysfunction

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800015028

Enrollment

Unknown

Registered

2018-03-01

Start date

2018-03-05

Completion date

Unknown

Last updated

2018-03-05

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

Conditions

Erectile dysfunction

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:Compound Xuan Ju Jiao Nang (0.42g / tablets), 1.26g Tid, taking a total of 3 months

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: (1) 20-60 years old male; (2) ED history of at least 3 months, IIEF-5 scale score = 21 points; (3) the general health of the body, a stable heterosexual partner more than 3 months; (4) Conditional guaranteed at least once a week of sex life; (5) ED was not treated by other means including PDE5-i within the first 4 weeks of grouping; (6) After the treatment period to ensure that every visit 3-5 days before abstinence; (7) The patient volunteered to participate in the trial and signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) ED due to hormonal, neurological or psychogenic factors; (2) have cognitive disorders and abnormal psychiatric symptoms; (3) any previous surgery that affected erectile function such as radical prostatectomy, pelvic surgery, or radical prostatectomy; (4) pelvic radiotherapy postoperative; (5) have confirmed penile hemangiomas; (6) any unstable medicine, spinal cord injury, abnormal anatomy of the penis; (7) penile artery or cavernous artery obstruction; (8) recovering from cancer in the past year; (9) Hypertension Poor blood pressure control (systolic blood pressure after treatment = 160mmHg and diastolic blood pressure = 100mmHg who); (10) poor control of diabetes (after treatment, fasting blood glucose levels> 7.0mmol / L were); (11) liver and kidney dysfunction; (12) other patients with poor control of disease; (13) the use of anti-androgen, androgen drugs; (14) who have participated in other clinical trials in the past 3 months; (15) Patients who other researchers think are not suitable for this trial.

Design outcomes

Primary

Measure	Time frame
Intemational Index of Erectile Function 5.IIEF-5;Erection Hardness Score;GAQ;SEP-2,3;	—

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