| CTRI Number |
CTRI/2022/11/047730 [Registered on: 28/11/2022] Trial Registered Prospectively |
| Last Modified On: |
25/11/2022 |
| 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 Efficacy and Safety of RSF0020G for the management of cognitive functions in Healthy human volunteers. |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Study to Evaluate the Efficacy and Safety of RSF0020G on management of cognitive functions 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 |
Dr Harshith CS |
| Designation |
Assistant Professor |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
No.67, BGS Health and Education City,Uttarahalli Road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9482164779 |
| Fax |
|
| Email |
drharshithcs.research@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bioservices Pvt. Ltd |
| Address |
Department of Clinical Research #9,Mythri Legacy, 202 1st Floor,Chelekere Kalyan Nagar (PO)
Bangalore
KARNATAKA
560043
India |
| Phone |
09845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bioservices Pvt. Ltd |
| Address |
Department of Clinical Research #9,Mythri Legacy, 202 1st Floor,Chelekere Kalyan Nagar (PO)
Bangalore
KARNATAKA
560043
India |
| Phone |
09845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Akay Natural Ingredients Pvt. Ltd.
Malaidamthuruthu P. O
Ernakulam, Cochin 683561
Kerala, India
|
|
|
Primary Sponsor
|
| Name |
Akay Natural Ingredients Pvt. Ltd. |
| Address |
Malaidamthuruthu P. O
Ernakulam, Cochin 683561
Kerala, 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 Harshith CS |
BGS Global Institute of Medical Sciences |
Room No:3,4th Floor, Department of General Medicine No.67, BGS Health and Education City,Uttarahalli Road, Kengeri
Bangalore
KARNATAKA |
09482164779
drharshithcs.research@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 250mg capsule every night for 84 days |
| Intervention |
RSF0020G |
Oral administration of single dose of RSF00220G 250 mg capsule every night for 84 days
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with normal cognitive function.
2.Subjects with a MMSE Score ≥ 23.
3.Diabetes, hypertension and other medical condition patients should be on stable medication. for last 3 months
4.Non-smokers
5.Able to communicate verbally, able to write and speak English and comfortable with using computer.
6.Must be willing and able to give informed consent and comply with the study procedures.
|
|
| ExclusionCriteria |
| Details |
1.Subjects with history of chronic diseases
2.Subjects who maybe allergic to any of the natural constituents of the Investigational Product.
3.Known HIV or Hepatitis B positive or any other immuno-compromised state.
4.Subjects on any other medical or clinical investigation or on any nutrition supplements and dietary regime.
5.Subjects visually or mentally handicapped or having difficulty to communicate
6.History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
7.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in cognitive function evaluated by Neuropsychological assessment |
Day 0, Day 42, Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Biomarkers |
Day 0, 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)
|
05/12/2022 |
| 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="0"
Months="6"
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
|
This is a randomized (1:1), double-blind, placebo-controlled, parallel group clinical study. Healthy subjects aged 35-60 years with normal cognition assessed by Mini-Mental State Examination (MMSE) and meeting all inclusion and no exclusion criteria will sign a written informed consent and will be enrolled in the study. After passing the eligibility criteria, subjects will be randomized into 2 treatment arms to receive RSF0020G or placebo in 50:50 ratio. The subject will arrive at the study site in a fasted state and blood samples will be collected for laboratory assessments. Post blood sample collection, the subjects will undergo various assessments to evaluate their cognitive functions. The subjects will visit the site on 4 different occasions during the 12-week study duration. |