The effect of Epilobium angustifolium L. supplement on prostate health
- Conditions
- Mild/moderate benign prostatic hypertrophy (BPH)Urological and Genital DiseasesHyperplasia of prostate
- Registration Number
- ISRCTN18705154
- Lead Sponsor
- EPO Srl
- Brief Summary
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33765581/ (added 13/08/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 128
1. Aged over 45
2. No clinically significant deviation in laboratory tests
3. History of mild BPH for at least 1 year
4. Pharmacologically treated but not controlled BPH
5. IPSS score = 8 and = 19 (moderate symptoms)
6. Prostate volume = 25cc and = 70cc
7. PVR between 30 ml and 200 ml
8. PSA = 4 ng/ml
1. Acute or chronic disease that could interfere with the study or dangerous for the participant
2. Use of any of the following concomitant drugs: immunosuppressants, anticoagulants, a-blockers, 5a-reductase inhibitors, antipsychotics, chemotherapy drugs, drugs for dementia, male hormone replacement therapy and drugs for overactive bladder, atonic and/or neurogenic bladder
3. Bladder neck contracture
4. Acute prostatitis; bladder calculosis: urinary tract infection more than once in the last 12 months
5. Prostate or bladder cancer; history of pelvic trauma or surgery; clinically significant kidney or hepatic insufficiency
6. Microscopic hematuria that was not evaluated by a urologist and not attributed to BPH
7. Any condition that might interfere with the subject's ability to give informed consent, to comply with study instructions, to provide an objective evaluation of his or her symptoms, or that might confuse the interpretation of study results
8. Those considered unsuitable for the participation by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method