None listed
Conditions
Interventions
Intervention1: VISPO: 500 mg capsule containing 200 mg of VISPO, twice a day ( morning and evening) orally for 84 days
Control Intervention1: SPO
: 500 mg capsule containing 200 mg of SPO, twice a day
Sponsors
Vidya Herbs Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: At screening, subject has a 1 IPSS > 7 2 AMS score >= 27 3 ADAM questionnaire items 1 or 7 or any other questions as positive 4 Must be willing and able to give informed consent and comply with the study procedures
Exclusion criteria
Exclusion criteria: 1 Has a history of prostate cancer or carcinoma of the prostate or, 2 Subjects with known history of serum PSA concentration > 4 ng/ml must have prostate cancer ruled out to the satisfaction of the investigator. 3 Has a residual void volume > 250 mL 4 History of Neurogenic bladder dysfunction, Has bladder neck contracture or urethral stricture,Has acute or chronic prostatitis or urinary tract infection, Serious medical co-morbidity, Haematuria diabetes; any prior surgery which could induce dysuria, Use of any other herbal medications for treatment of BPH, associated symptoms and Erectile Dysfunction in past 1 month,Diuretics or drugs with antiandrogenic or alpha-receptor properties in the preceding 3 months. 5 Subjects allergic to herbal products or any component of the study product 6 Known HIV or Hepatitis B positive or any other immuno-compromised state 7 Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 8 Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the following parameter from baseline to end of treatment 1.Post-voidal residual volume of urine 2.IPSS score 3. ADAM questionnaire score 4.AMS score Timepoint: Day 0, Day 42, Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in 1.Uroflowmetry parameters 2.Biomarkers 3.Safety Parameters 4.Quality of Life ScoreTimepoint: Day 0, Day 84 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt.Ltd
Outcome results
None listed