| CTRI Number |
CTRI/2022/10/046400 [Registered on: 12/10/2022] Trial Registered Prospectively |
| Last Modified On: |
27/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Prostate24 in prostate enlargement |
|
Scientific Title of Study
|
An open-labelled, prospective clinical study to evaluate effect of Prostate24 in benign prostatic hyperplasia male human patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tapan Shah |
| Designation |
Consultant Physician |
| Affiliation |
Sangini hospital |
| Address |
First floor and 708, Satellite, Ahmedabad
first floor and 708, Satellite, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
9825739241 |
| Fax |
|
| Email |
drtapansah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shital Sharadkumar Panchal |
| Designation |
Associate Professor |
| Affiliation |
Institute of Pharmacy Nirma University |
| Address |
SG HIGHWAY, CHHARODI, AHMEDABAD
SG HIGHWAY, CHHARODI, AHMEDABAD
Ahmadabad
GUJARAT
382481
India |
| Phone |
9687626589 |
| Fax |
|
| Email |
shital.panchal@nirmauni.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Shital Sharadkumar Panchal |
| Designation |
Associate Professor |
| Affiliation |
Institute of Pharmacy Nirma University |
| Address |
SG HIGHWAY, CHHARODI, AHMEDABAD
SG HIGHWAY, CHHARODI, AHMEDABAD
Ahmadabad
GUJARAT
382481
India |
| Phone |
9687626589 |
| Fax |
|
| Email |
shital.panchal@nirmauni.ac.in |
|
|
Source of Monetary or Material Support
|
| Probiotic Smart LLC, 302 Cedar Falls Road, Menomonie, WI 54751, USA |
|
|
Primary Sponsor
|
| Name |
Institute of Pharmacy Nirma University |
| Address |
Institute of Pharmacy, Nirma University
SG HIGHWAY, CHHARODI, AHMEDABAD |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Probiotic Smart LLC |
302 Cedar Falls Road, Menomonie, WI 54751, USA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tapan Shah |
Sangini hospital |
First floor and 708, Clinical Research Department, Satellite, Ahmedabad
Ahmadabad
GUJARAT |
09825739241
drtapanshah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sangini Hospital Ethic Committee |
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 |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Prostate24 |
Prostate24, 400 mg capsule (oral), twice a day for 60 days |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
i. Age above 45 years
ii. Male participants diagnosed with BPH
iii. Participant must not have taken any drug/ vitamin/ mineral/ dietary or herbal supplements for BPH 1 month prior to enrolment in the study and agrees to not use any new vitamins and/or minerals and/or dietary and/or herbal supplements until after study completion.
iv. Participant must be able, willing and likely to fully comply with study procedures and restrictions.
v. Participant willing to sign the informed consent
|
|
| ExclusionCriteria |
| Details |
i. Evidence of renal disease (S. Creatinine > 1.5mg/ml)
ii. Evidence of liver disease (AST/ALT >3 times of normal)
iii. History of alcohol intake and smoking.
iv. Participation in any other clinical trial with in the last 30 days
v. History of intake of diuretics, Finasteride like drugs or dietary supplements for the treatment of BPH
vi. History of intolerance or hypersensitivity to any of the content of the study drug
vii. Any condition which in the opinion of the PI that is significant and can make the subject unsuitable for study or can place it under additional risk, such as intolerance, allergy to study drug, etc
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean percent changes in the overall signs and symptoms of BPH after the treatment with Prostate24 from baseline to 60 days. These will include,
• Physical examination and DRE
• PSA
• CRP
• Sr. Creatinine
|
0, 30, 60 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the adverse drug reactions of Prostate24 |
0, 30, 60 day |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
17/10/2022 |
| 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
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
|
PROTOCOL NUMBER
|
IPNU/002/22
|
|
PROTOCOL TITLE
|
An Open-Labelled, Prospective Clinical Study to
Evaluate Effect of Prostate24 In Benign Prostatic Hyperplasia Male Human
Patients.
|
|
AIM
|
The aim of the proposed study is to evaluate effect
of Prostate24, a nutraceutical formulation on BPH patients.
|
|
OBJECTIVES
|
Primary Objective: To evaluate mean changes in the
overall signs and symptoms of BPH after the treatment with Prostate24 from
baseline to 60 days.
Secondary Objective: To assess the safety of
Prostate24 based upon basic vital signs.
|
|
NUMBER OF PATIENTS
|
15
|
|
STUDY MEDICATION
|
Prostate24; each contains curcuminoids and zinc
complex (150mg) and proprietary blend of Pygeum africanum, Say palmetto
and Nelumbo nucifera (250mg).
|
|
DOSE AND METHOD OF ADMINISTRATION
|
Prostate24 [400mg] Capsule twice a day orally.
|
|
STUDY DURATION
|
Total expected duration of study will be for 60
days.
|
|
TOTAL BLOOD LOSS
|
Total blood loss in this study will not be more than
30 ml.
|
|