A double-blind, randomised, placebo-controlled study to evaluate the effect of an orally-dosed herbal extract, Ageratum conyzoides, for the treatment of benign prostatic (BPH) symptoms in otherwise healthy males.
- Conditions
- Benign Prostatic HypertrophyAlternative and Complementary Medicine - Herbal remediesRenal and Urogenital - Other renal and urogenital disorders
- Registration Number
- ACTRN12614001074684
- Lead Sponsor
- Integrated Health Group Pty. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 100
Inclusion Criteria
Male aged between 45-80
Medically diagnosed with BPH
Minimum score of 8 in the IPSS
Written informed consent from the subject
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 coumandin (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 Day-time and night time urinary frequency - Assessed using a 1 week Patient Daily Diary.[Baseline, month 1, month 2 and month 3];Symptoms of BPH - Assessed by the IPSS (International Prostate Symptom Score) <br><br>[Baseline, month 1, month 2 and month 3]
- Secondary Outcome Measures
Name Time Method Sleep quality - Assessed by the Pittsburgh Sleep Questionnaire <br><br>[Baseline, month 1, month 2 and month 3];Hormones - Sex hormone binding globulin (SHBG) and Serum testosterone levels - assessed by blood test[Baseline and week 12]