Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202304488683045 Date of Approval: 20/04/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of phytotherapy (Uriphytol) versus Tamsulosin in management of benign prostatic obstruction at KCMC: A 6-months Randomized Clinical Trial
Official scientific title Effectiveness of phytotherapy (Uriphytol) versus Tamsulosin in management of benign prostatic obstruction at KCMC: A 6-months Randomized Clinical Trial
Brief summary describing the background and objectives of the trial Lower Urinary tract symptoms due to BPO have increasingly been recognized among the aging men. 30-40% of men in their 4th decade of life have been reported to have BPO, and the prevalence of 70-80% have been reported in those aged more than 80 years (Madersbacher and Culig, 2019). In Tanzania, one of the studies in Dodoma reported the prevalence of BPH to be 60%, although there is paucity of literature in most developing countries, East Africa inclusive (Mwashambwa et al., 2015) In the past two decades, there have been increased uses of phytotherapeutic agents in treating LUTS caused by BPO; mainly investigated agents are Serenoa repens, (American dwarf palm i.e. saw palmetto) and Pygeum africanum (from the bark of the African plum tree), (Navarrete, 2012) According to WHO report on traditional medicine usage, about 80% of the African population relies on traditional herbal medicine mixtures to meet their health care needs. Tanzania’s reported usage of Traditional medicine was 60%.However, the extent to which patients with symptomatic BPH use locally produced traditional medicine is not known neither its effectiveness in relieving the symptoms. This RCT aims to investigate the effectiveness of phytotherapeutic drug, Uriphytol capsules(made at iPhytos Company Ltd. Tanzania) as compared to Pharmacological agents in managing BPH with the following objectives; -To compare the therapeutic effect of phytotherapy (uriphytol) and tamsulosin in relieving the LUTS consistent with BPO among patients managed at KCMC -To examine the change in PVR volume among patients with BPO managed with Phytotherapy (uriphytol) as compared to Tamsulosin at KCMC. -To compare the change in erectile function scores among patients with BPO treated by phytotherapy (uriphytol) and tamsulosin at KCMC.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial URIPHYTOL CAPSULES: PHYTOTHERAPY FOR SYMPTOMATIC BPH
Anticipated trial start date 25/09/2023
Actual trial start date 29/09/2023
Anticipated date of last follow up 30/09/2024
Actual Last follow-up date 04/10/2024
Anticipated target sample size (number of participants) 88
Actual target sample size (number of participants) 82
Recruitment status Closed to recruitment,follow-up continuing
Publication URL zerracheyo@gmail.com
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group URIPHYTOL CAPSULES Uriphytol capsules will be taken orally, 500mg 8 hourly 1 month Patients will be receiving the monthly dose of Uriphytol capsules and being re-filled with the medication after every month. The follow up will be done in a 3-monthly basis in which parameters that answer the objective of the study will be assessed: the Change in severity of symptoms using an International Prostate Symptoms score and Quality of life score questionnaire, the change in Post void Residual volume by the use of a Transabdominal Ultrasound (KUB-ultrasound), the change in prostate volume using a Transabdominal Ultrasound (KUB-ultrasound) and lastly, the immediate side effects experienced by the participants during the use of medication including the symptoms and signs reported by the patient, any change in serum PSA values and any change in sexual function using the IIEF-15 questionnaire 44
Control Group TAMSULOSIN AND COMBINED TAMSULOSIN AND FINASTERIDE STANDARD MEDICAL THERAPY GROUP 1. 0.4MG ONCE DAILY FOR TAMSULOSIN MONOTHERAPY 2. 5MG ONCE DAILY FOR FINASTERIDE WHEN A COMBINATION THERAPY IS INDICATED ALL THE DRUGS WILL E TAKEN FOR 1 MONTH Patients will be prescribed with Tmasulosin medications which will be used in a monthly basis or a combined treatment of Tamsulosin and Finasteride when indicated, and use them in a monthly basis. Same parameters as in the interventing group will be assessed after every 3 month period in which, the Change in IPSS, PVR, Prostate volume and immediate side effects including changes in serum PSA levels and IIEF-15 score will be determined throughout the whole time of the study (12 months) 44 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. -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 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 100 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/02/2023 Kilimanjaro Christian Medical University College Research Ethics and Review Committee
Ethics Committee Address
Street address City Postal code Country
KCMU College Moshi 2240 Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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. 3 months, 6 months, 9 months and 12 months, WITH TWO END-POINTS ANALYSIS AT 6 AND 12 MONTHS
Secondary Outcome 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). 3, 6, 9 and 12 months respectively, with TWO END-POINTS ANALYSIS AT 6 AND 12 MONTHS
Secondary Outcome 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. 3, 6, 9 and 12 months respectively, with TWO END-POINTS ANALYSIS
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
UROLOGY DEPARTMENT KILIMANJARO CHRISTIAN MEDICAL ENTRE P.O.BOX 3010 MOSHI Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
SELF P.O.BOX 3010 MOSHI Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor IPHYTOS COMPANY LIMITED P.O.BOX 15014 ARUSHA Tanzania Commercial Sector/Industry
Primary Sponsor KILIMANJARO CHRISTIAN MEDICAL CENTRE P.O.BOX 3010 MOSHI United Republic of Tanzania Hospital
COLLABORATORS
Name Street address City Postal code Country
KILIMANJARO CHRISTIAN MEDICAL CENTRE P.O.BOX 3010 MOSHI Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ZERRA ISRAEL CHEYO zerracheyo@gmail.com +255746464533 P.O.BOX 3010
City Postal code Country Position/Affiliation
MOSHI Tanzania A RESIDENT IN UROLOGY
Role Name Email Phone Street address
Scientific Enquiries Orgeness Jasper Mbwambo orgeness@live.com +255713863733 P.O.BOX 2240
City Postal code Country Position/Affiliation
MOSHI Tanzania A LECTURER IN UROLOGY
Role Name Email Phone Street address
Public Enquiries DANIEL MADULU SHADRACK dmshadrack@gmail.com +255752943392 P.O.BOX 15014
City Postal code Country Position/Affiliation
ARUSHA Tanzania CHIEF EXECUTIVE OFFICER OF IPHYTOS COMPANY LTD AND LECTURER AT NELSON MANDELA AFRICAN INSTITUTE OF SCIENCE AND TECHNOLOGY
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 1. Individual participant data that underlie the results reported in this article, after de-identification (this includes text, tables, figures, and appendices) will be made available 2. Anyone who wishes to access the data for any purpose will gain access through some criteria Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, there will be No end date To gain access, data requestors will need to sign a data access agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://pactr.samrc.ac.za Yes 23/08/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 23/08/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information