Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms
Conditions
Interventions
Intervention1: Fenugreek extract: Dose: 500mg
Dosage form: Capsules
Route of administration: Orally
Frequency: One capsule orally in the morning before breakfast
Duration:84 days
Control Interv
Sponsors
Daehan chemtech co., Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male greater than or equal to 40 to less than or equal to 70 years of age. 2. Testosterone range between 3.0-5.0 ng/mL. 3. At screening, subject has a IPSS greater than or equal to 8 and less than or equal to 19 AMS score greater than or equal 27 to less than or equal to 50 4. Must be willing and able to give informed consent and comply with the study procedures.
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of prostate cancer or carcinoma of the prostate or subjects with known history of serum PSA concentration greater than 4 ng/ml (must have prostate cancer ruled out to the satisfaction of the investigators). 2. Subjects with a residual void volume of greater than 150 mL. 3. Subjects with maximum urine flow rate of less than 5 mL/sec. 4. Subjects with uncontrolled hypertension (SBP greater than 160 mmHg or DBP greater than 100 mmHg). 5. Subjects with uncontrolled diabetes (fasting blood sugar level greater than 130 mg/dL). 6. Subjects who report consuming alcoholic beverages or active nicotine consumption (smoking cigarettes, vaping / ecigarettes, chewing tobacco, snuff, etc.) within the last 30 days as evidenced by self reporting. 7. Subjects with BMI greater than or equal to 35kg/m2. 8. Subjects who are currently receiving treatment for severe cardiovascular, immune, respiratory, gastrointestinal / liver and biliary tract, kidney and urinary, nervous, 9. Subjects with history of neurogenic bladder dysfunction or bladder cancer. 10. Subjects with acute or chronic prostatitis, urinary tract infection, hematuria, diabetes or any other chronic illness, which in the opinion of the investigator would warrant exclusion from the study or prevent the subject from completing the study. 11. Subjects with bladder neck contracture or urethral stricture. 12. Subjects with any serious medical comorbidity. 13. Subjects with history of any prior surgery which could induce dysuria. 14. Subjects using any other herbal medications for treatment of BPH and/or and associated symptoms. 15. Subjects with erectile dysfunction in the past 1 month. 16. Subjects with history of alcoholism or drug abuse. 17. Subjects who are on 5alpha reductase inhibitors, alpha blockers, anticholinergics, antidiuretic hormones, antimuscarinics, or any other herbal medications (including health functional foods) for treatment of BPH and associated symptoms within 12 weeks of visit 1. 18. Subjects who are on testosterone replacement therapy (TRT) including testosterone undecanoate, testosterone enanthate, testosterone cypionate, testosterone ester, phoshodiestearase 5 (PDE 5) inhibitors, LH RH analogs, statins, fibrates, niacin, steroid, fish oil, colistin, fiber based laxatives, phytosterol margarines, anti diabetic agents, antiplatelet agents, thyroxine, diuretics, beta-blockers, any other anti-androgenic agents, treatment for erectile dysfunction (ED), or any other herbal medications (including health functional foods) for treatment of male menopause and associated symptoms within 12 weeks of visit 1. 19. Subjects who are allergic to herbal products or any component(s) of the study products. 20. Subjects who are known to be HIV or hepatitis B positive or known to have any other immune compromised state. 21. Subjects who are currently participating or having participated in any other clinical trial during the past 3 months prior to the beginning of this study. 22. Any additional condition(s) that in the opinion of the investigators would warrant exclusion from the study or prevent the subject from completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the following parameters from baseline to end of treatment 1.Post-void residual volume of urine 2.IPSS score 3.Uroflowmetry parameters: Maximum urine flow rate Average urine flow rate Time to maximum flow rate Delay time (hesitancy) Timepoint: 1.Post-void residual volume of urine --- Day 0 and Day 84 2.IPSS score - Day 0,Day 42 and Day 84 3.Uroflowmetry parameters Day 0 and Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the following parameters from baseline to end of treatment 1. ADAM questionnaire score 2. AMS score 3. Quality of life score 4. Laboratory parameters Prostate specific antigen (PSA) 17 beta-hydroxysteroid dehydrogenase (17 beta HSD) 3 beta-hydroxysteroid dehydrogenase (3 beta HSD) 5 alpha-reductase Testosterone & free testosterone Serum creatinine Blood urea nitrogen CBC AST & ALT Urine analysis Basic hematology & biochemistry parameters 5. Safety (incidence of adverse events) assessment Timepoint: 1. ADAM questionnaire score-- Day 0,Day 42 & Day 84 2. AMS score - Day 0,Day 42 & Day 84 3. Quality of life score - Day 0,Day 42 & Day 84 4. Laboratory parameters & urine analysis: Day 0 & day 84 | — |
Countries
India
Contacts
Public ContactDrVijendra R
Bangalore Clinical Services
Outcome results
None listed