| CTRI Number |
CTRI/2021/04/033122 [Registered on: 26/04/2021] Trial Registered Prospectively |
| Last Modified On: |
24/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
effect of alpha blockers in benign prostatic hyperplasia |
|
Scientific Title of Study
|
A prospective study to evaluate the efficacy and adverse effects of alpha blockers in the management of benign prostatic hyperplasia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR I C VIGNESH RAJA |
| Designation |
POST GRADUATE |
| Affiliation |
DHANALAKSHMI SRINIVASAN MEDICAL COLLEGE AND HOSPITAL |
| Address |
DHANALAKSHMI SRINIVASAN MEDICAL COLLEGE AND HOSPITAL PERAMBALUR
Perambalur
TAMIL NADU
621212
India |
| Phone |
9443080854 |
| Fax |
|
| Email |
vigneshraja36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR M SARAVANA KUMAR |
| Designation |
PROFESSOR HOD |
| Affiliation |
DHANALAKSHMI SRINIVASAN MEDICAL COLLEGE AND HOSPITAL |
| Address |
DHANALAKSHMI SRINIVASAN MEDICAL COLLEGE AND HOSPITAL PERAMBALUR
Perambalur
TAMIL NADU
621212
India |
| Phone |
9443080854 |
| Fax |
|
| Email |
sharavankumar1923@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR I C VIGNESH RAJA |
| Designation |
POST GRADUATE |
| Affiliation |
DHANALAKSHMI SRINIVASAN MEDICAL COLLEGE AND HOSPITAL |
| Address |
DHANALAKSHMI SRINIVASAN MEDICAL COLLEGE AND HOSPITAL PERAMBALUR
Perambalur
TAMIL NADU
621212
India |
| Phone |
9443080854 |
| Fax |
|
| Email |
vigneshraja36@gmail.com |
|
|
Source of Monetary or Material Support
|
| DHANALAKSHMI SRINIVASAN MEDICAL COLLEGE HOSPITAL |
|
|
Primary Sponsor
|
| Name |
DR I C VIGNESH RAJA |
| Address |
DHANALAKSHMI SRINIVASAN MEDICAL COLLEGE HOSPITAL PERAMBALUR |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR I C VIGNESH RAJA |
DHANALAKSHMI SRINIVASAN MEDICAL COLLEGE HOSPITAL |
DHANALAKSHMI SRINIVASAN MEDICAL COLLEGE HOSPITAL PERAMBALUR
Perambalur
TAMIL NADU |
9443080854
vigneshraja36@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Human Study |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Silodosin |
8mg once daily orally for 8 weeks |
| Intervention |
Tamsulosin |
0.4 mg once daily orally for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
Benign prostatic hyperplasia with international prostatic symptom score above 7
Patient on silodosin
Patient on tamsulosin
willing to give informed consent
|
|
| ExclusionCriteria |
| Details |
Prostate carcinoma
Patients with concomitant HIV, HBV or HCV
Renal failure
Liver disease
Patient planned for cataract surgery.
Psychiatry patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in IPSS |
4th week
8th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| adverse drug reactions |
4th week
8th week |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/05/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In aging males lower urinary tract symptoms (LUTS) are a common problem and the most common cause for LUTS in elderly men is benign prostatic hyperplasia.Benign prostatic hyperplasia (BPH) is defined as a non malignant enlargement of the prostate associated with aging. In this condition the overgrowth of prostate tissue pushes against the urethra and the bladder, blocking the flow of urine. Clinical manifestations include obstruction in urine flow, discomfort and pain during urination.Prevalence of BPH is more between 50 to 70 yrs male and it accounts nearly 8% of men aged between 45 - 50 years and when men cross 80 years of age the prevalence rate is almost 80%.The treatment depends on the severity of symptoms. Management approaches range from observation only, to medical therapy, to minimally invasive, endoscopic or open surgery. Medical therapy works by reducing dynamic and static components. Alpha1a adrenergic receptor inhibition with selective (tamsulosin, silodosin, terazosin, alfuzosin) or non-selective (prazosin) drugs treat the dynamic component of benign prostatic hyperplasia. Among themSelective alpha 1 adrenergic antagonist are the first line drugs in the medical management of BPH.Tamsulosin blocks alpha 1 receptors in smooth muscles both in bladder neck and prostate which leads to relaxation and subsequently less resistance to urinary flow. Silodosin is a newer drug and it is a selective antagonist of post synaptic alpha 1 adrenoreceptors, which are located in human prostate, bladder base, bladder neck and prostatic urethra. Blockade of these alpha 1 adrenoreceptors can cause smooth muscles in the tissues to relax, resulting in an improvement in urine flow and reduction in BPH symptoms.The current study aimed to determine the effectiveness and adverse effects of silodosin with comparison of tamsulosin in symptomatic BPH |