| CTRI Number |
CTRI/2021/12/038621 [Registered on: 14/12/2021] Trial Registered Prospectively |
| Last Modified On: |
08/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the safety and efficacy of VISPO in healthy subjects. |
|
Scientific Title of Study
|
A double blind, placebo controlled, parallel group, prospective clinical study to evaluate the urodynamic parameters and tolerability of a standardized saw palmetto oil, VISPO in healthy subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrJayashree Sseeri |
| Designation |
Principal Investigator |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
Department of Community Medicine,BGS Global Institute of Medical Sciences #67, BGS health and Education city, Uttarahalli road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9482164779 |
| Fax |
|
| Email |
drjayashree.ct@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research, #9, 1st floor, Mythri Legacy, Chelekere main road, Kalyan nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research, #9, 1st floor, Mythri Legacy, Chelekere main road, Kalyan nagar
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vidya Herbs Pvt Ltd,Vidya Building, N3-3,24th main road, 1st Phase, JP Nagar Bengaluru, Karnataka - 560078,India |
|
|
Primary Sponsor
|
| Name |
Vidya Herbs Pvt Ltd |
| Address |
Vidya Building,N3-3,24th main road, 1st Phase, JP Nagar Bengaluru, Karnataka - 560078,India |
| Type of Sponsor |
Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients] |
|
|
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 Jayashree S Seeri |
BGS Global Institute of Medical sciences |
Department of community medicine, BGS Global Institute of Medical Sciences #67, BGS health and Education city, Uttarahalli road, Kengeri
Bangalore
KARNATAKA |
9482164779
drjayashree.ct@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BGS Global Institute of Medical Scineces Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
With Normal Biochemical and Hematological Parameters |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Oral administration of single dose of Placebo capsules everyday for 84 days |
| Intervention |
VISPO |
Oral administration of single dose of VISPO capsules everyday for 84 days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1.Subjects with normal BMI of 18.5-24.9 kg/m2
2.Subjects who have no evidence of any underlying disease
3.Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), oral or long acting injected contraceptives] from at least 2 months prior to study entry and through the duration of the study; or postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject); with a negative urine pregnancy test.
4.Must be willing and able to give informed consent and comply with the study procedures
|
|
| ExclusionCriteria |
| Details |
1.Subjects suffering from any chronic health conditions (e.g. diabetes, hypertension, chronic renal failure, heart, thyroid and liver disease) requiring medical treatment
2.History of Chronic metabolic disease.Psychiatric illness,Drug abuse, smoking, abuse/addiction to alcohol,Eating disorder such as bulimia or binge eating,Endocrine abnormalities including stable thyroid disease,Cardiovascular surgery / History of any major surgery
3.Subjects allergic to herbal products
4.Known HIV or Hepatitis B positive or any other immuno-compromised state
5.Diagnosis of any other clinically significant medical condition which in opinion of investigator may jeopardize subject’s safety and preclude trial participation.
6.Currently participating or having participated in another clinical trial during the last 1 month 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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Uroflowmetry parameters and laboratory parameters |
Day 0, Day 42, Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| overall safety assessment |
Day 0, Day 42, Day 84 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
18/12/2021 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
This is a double blind, placebo controlled, parallel group,
two-arm, prospective clinical study. Healthy subjects meeting all inclusion and
no exclusion criteria, after signing a written informed consent will be
enrolled in the study.After passing the eligibility criteria, subjects will be
randomized into 2 treatment arms to receive VISPO or placebo in
1:1 ratio.The subject will arrive at the study site in a fasting state
and blood samples will be collected for laboratory assessment . Post blood sample collection, subjects will undergo uroflowmetry assessments. The study will be conducted in 3 visits over a period of 84 days
|