A double-blind, randomised, placebo-controlled study to evaluate the effect of an orally-dosed herbal extract, Testofen, for the treatment of Benign Prostatic Hyperplasia (BPH) symptoms in otherwise healthy males.

A prospective, double-blind, randomised, placebo-controlled study to evaluate the efficacy of a complementary medicine formulation, to treat symptoms of Benign Prostatic Hyperplasia (BPH) in otherwise healthy male adults.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615001242516

Enrollment

Registered

2015-11-12

Start date

2016-09-22

Completion date

2017-11-20

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

This is a double-blind, randomised, placebo-controlled study to evaluate the effect of a herbal extract. The aim is to investigatge if the formulation treats benign prostatic hyperplasia (BPH) symptoms in otherwise healthy males.

Interventions

The treatment is an ARTG listed (Aust L 187768) commercially available capsule-form herbal medicine containing 300mg Trigonella foenum-graecum (Fenugreek) seed extract. The daily dose is 2 capsules per day (total 600mg) taken with the evening meal for a period of 3 months. Active ingredient: Trigonella foenum-graecum extract 300mg equivalent to dry seed 9.9g Excipient ingredients: Maltodextrin All participants are provided with a bottle of the product (active or placebo) and a daily urinary frequency diary. The International Prostate Symptom Score (IPSS) QOL questionnaire and the Male Sexual Health Questionnaire (MSHQ) will be administered at Baseline, Week 4, Week 8 and at trial completion (Week 12). The Pittsburgh Sleep Quality Index will be administered at Baseline and trial completion (Week 12). The following blood tests will also be performed to assess the affect of the product on Dihydrotesterone (DHT), Sex Hormone Binding Globulin (SHBG), serum testosterone and Prostate Specific Antigen (PSA) levels. Adherence to the intervention will be monitored by drug tablet return.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

Male

Age

45 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Male aged between 45-80 years * Medically diagnosed with BPH * Minimum score of 8 in the IPSS * Capable of providing informed consent * Able to attend the required clinics

Exclusion criteria

* Known hypersensitivity to herbal drugs/nutritional supplement/ foods * Have used a drug/natural therapy for BPH or other urological symptoms within the last 30 days? * Have had urogenital surgery within the last 6 months? * Have had bladder biopsy and/or cystoscopy and biopsy within the past 30 days? * Have been diagnosed with chronic persistent local pathology (e.g. interstitial cystitis, bladder stones)? Receiving/ prescribed Coumadin (Warfarin) or other anticoagulation therapy * Diagnosed genital anatomical deformities, uncontrolled diabetes mellitus, and history of spinal cord injury, uncontrolled psychiatric disorder, and/or abnormal secondary sexual characteristics * Diagnosed prostatic cancer or benign hypertrophy; if suspected by the investigator, refer for medical assessment * Current or history of chronic alcohol and/or drug abuse

Outcome results