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.
- Conditions
- Treatment of Benign Prostatic Hyperplasia (BPH)Alternative and Complementary Medicine - Herbal remediesRenal and Urogenital - Other renal and urogenital disorders
- Registration Number
- ACTRN12615001242516
- Lead Sponsor
- Amanda Rao
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 100
* 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
* 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of day time and night time urination<br>Day time and night time urination to be recorded at Baseline (Week 1 Day 1) until trial completion (Week 12 Day 7) using a Daily Diary.[Day time and night time urination to be recorded at Baseline (Week 1 Day 1) until trial completion (Week 12 Day 7) using a Daily Diary.];BPH symptoms<br>BPH symptoms to be assessed using the International Prostate Symptom Score (IPSS) QOL questionnaire at Baseline, Week 4, Week 8 and trial completion (Week 12).[BPH symptoms to be assessed using the International Prostate Symptom Score (IPSS) QOL questionnaire at Baseline, Week 4, Week 8 and trial completion (Week 12).]
- Secondary Outcome Measures
Name Time Method Male sexual health related to lower urinary tract symptoms<br>Male sexual health to be assessed using the Male Sexual Health Questionnaire (MSHQ) at Baseline, Week 4, Week 8, and trial completion (Week 12).[Male sexual health to be assessed using the Male Sexual Health Questionnaire (MSHQ) at Baseline, Week 4, Week 8, and trial completion (Week 12).];Sleep quality<br>Sleep quality to be assessed using the Pittsburgh Sleep Quality Index questionnaire at Baseline and trial completion (Week 12).[Sleep quality to be assessed using the Pittsburgh Sleep Quality Index questionnaire at Baseline and trial completion (Week 12).];DHT[Levels to be assessed via blood test at Baseline and trial completion (Week 12).];SHBG[Levels to be assessed via blood test at Baseline and trial completion (Week 12).];Serum testosterone[Levels to be assessed via blood test at Baseline and trial completion (Week 12).];PSA levels[Levels to be assessed via blood test at Baseline and trial completion (Week 12).]