Health Condition 1: N40- Benign prostatic hyperplasia
Conditions
Interventions
Intervention1: JACKPROTM: Oral administration of single dose of JACKPROTM capsules everyday for 84 days
Control Intervention1: Placebo: Oral administration of single dose of Placebo capsules everyday
Sponsors
Vidya Herbs Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.At screening, subject has IPSS score greater than 7,AMS score greater than 27 and ADAM questionnaire items 1 or 7 or any 3 other questions as positive 2.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 Subjects with known history of serum PSA concentration greater than 4 ng/ml must have prostate cancer ruled out to the satisfaction of the investigator. 2.Has a residual void volume greater than 250 mL 3.History of Neurogenic bladder dysfunction or bladder neck contracture or urethral stricture r acute or chronic prostatitis or urinary tract infection or Serious medical co-morbidity including Haematuria diabetes,any prior surgery which could induce dysuria, Use of any other herbal medications for treatment of BPH,or associated symptoms and Erectile Dysfunction in past 1 month or Diuretics or drugs with antiandrogenic or alpha-receptor properties in the preceding 3 months 4.Subjects allergic to herbal products or any component of the study product 5.Known HIV or Hepatitis B positive or any other immuno-compromised state 6.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 7.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 |
|---|---|
| Mean Change in Post-voidal residual volume of urine and change in Questionnaire based assessmentsTimepoint: Day 0, Day 42, Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in Quality of Life QuestionnaireTimepoint: Day 0, Day 42, Day 84;Mean change in the male hormonal markersTimepoint: Day 0, Day 84;Mean change in uroflowmetry parametersTimepoint: Day 0, Day 84 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed