Urological and Genital Diseases
Conditions
Interventions
URIPHYTOL CAPSULES
TAMSULOSIN AND COMBINED TAMSULOSIN AND FINASTERIDE STANDARD MEDICAL THERAPY GROUP
Sponsors
IPHYTOS COMPANY LIMITED
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: All patients aging 40 years and above, presenting for the first time in Urology clinic, KCMC with LUTS consistent with benign features on DRE, with any IPSS; PSA density< 0.15 ng/ml per ml of prostate tissue and have not been on other forms of treatment for BPH who will agree to participate and being followed up, will be included in the study.
Exclusion criteria
Exclusion criteria: -Patients who presents with severe LUTS (IPSS>19) with absolute criteria for surgical intervention like Renal insufficiency, recurrent gross hematuria due to prostate enlargement, recurrent urine retention, bladder stones and bladder diverticula secondary to prostate enlargement as a cause of bladder outlet obstruction -Patients with presence of concomitant benign prostate enlargement and uncontrolled Diabetes mellitus, Congestive cardiac disease, renal failures, urethral stricture disease, cystitis. -Patients who will be lost to follow up after recruitment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Effectiveness of the phytotherapeutic agent in comparison with the medical therapy will be primarily determined by assessing the relief in the Lower urinary tract symptoms among patients in both treatment arms after 3,6,9 and 12 months of treatment respectively. This will be measured by a standard tool of assessment, The International prostate symptoms score, in which a minimum of 3-point change from the baseline will be considered as a good response to treatment (Barry et al., 1995). This has been considered as a clinical relevant efficacy because IPSS is a gold standard tool for determining severity of symptoms due to BPH and as per multiple clinical trials; the score change has been reported. | — |
Secondary
| Measure | Time frame |
|---|---|
| The supportive outcome measures on investigating the effectiveness of phytotherapy as compared with medical therapy will be as follows: • Post-void residual volume; in which a volume of less than or equal to 100 cm³ is considered as non-significant. Therefore, in this study, a decrease of PVR volume from baseline to non-significant ranges will be considered as a good response to therapy. • Prostate volume; A decrease in prostate volume by 15-30 cm³ from the baseline after 6 months of therapy will be considered as a good response to therapy, as multiple trials have shown a significant decrease in prostate volume after 6 months (Blandy’s Urology, 2019). ;Other Outcome measures,Other outcome variables that will be assessed in this study are the adverse effects that will be reported by patients after a period of 3, 6, 9 and 12 months respectively including, ejaculation disorders, symptoms related to alpha receptor blockage like gastro-intestinal disorder, rhinitis, fatigue, asthenia, headache, dizziness, and postural hypotension, and any other adverse effects. These will be determined using guided closed ended questions and open ended questions to obtain the unusual AEs. These will reflect on the safety of the phytotherapeutic agents. This study will also determine any change that will occur in International Index of Erectile function of the patients who are sexually active from their baseline values. | — |
Countries
Tanzania
Contacts
Public ContactDANIEL MADULU SHADRACK
CHIEF EXECUTIVE OFFICER OF IPHYTOS COMPANY LTD AND LECTURER AT NELSON MANDELA AFRICAN INSTITUTE OF SCIENCE AND TECHNOLOGY
Outcome results
None listed