| CTRI Number |
CTRI/2024/02/062286 [Registered on: 05/02/2024] Trial Registered Prospectively |
| Last Modified On: |
29/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Safety and efficacy of herbal supplement (LN22203) in improving cognition, e-gaming performance, mood states in e-sports players. |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled clinical study to evaluate
influence of LN22203 supplementation on memory, e-sports performance and mood states
of young adults. |
| Trial Acronym |
NO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ARC/BH/LN22203/23 version 02 03-Aug-2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr CH Amulya |
| Designation |
Principal Investigator |
| Affiliation |
Aditya Multi Speciality Hospital |
| Address |
Department of Neurology, Room No-001, first Floor
13-3-52,4th Line,Gunturuvari thota,kothapet
Guntur
ANDHRA PRADESH
522001
India |
| Phone |
8500454689 |
| Fax |
8632220395 |
| Email |
researchaditya26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr CH Arun Kumar |
| Designation |
Clinical Research Head |
| Affiliation |
Aditya Research Center |
| Address |
Department of clinical research, Room No-003, first Floor
Aditya Multi Speciality Hospital,13-3-52,4th Line,Gunturuvari thota,kothapet
Guntur
ANDHRA PRADESH
522001
India |
| Phone |
08074710310 |
| Fax |
8632220395 |
| Email |
arunchadalavada@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms S Kalyani |
| Designation |
Manager |
| Affiliation |
Aditya Research Center |
| Address |
Department of clinical research,Room No-003, Ground Floor
Aditya Multi Speciality Hospital,13-3-52,4th Line,Gunturuvari thota,kothapet
Guntur
ANDHRA PRADESH
522001
India |
| Phone |
7416650815 |
| Fax |
8632220395 |
| Email |
kalyani.kkm294@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aditya Research Center
13-3-52, 4th Line, Gunturuvari thota,
Kothapet, Guntur, A.P - 522001,
India |
|
|
Primary Sponsor
|
| Name |
Aditya Research Center |
| Address |
13-3-52,
4th Line, Gunturuvari thota, Kothapet,
Guntur, A.P - 522001, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 CH Amulya |
ADITYA MULTYSPECIALITY HOSPITAL |
Department of Neurology, Neurology Division, Room No-001, first Floor 13-3-52, 4th Line, Gunturuvari thota, kothapet
Guntur, ANDHRA PRADESH 522001, India
Guntur
ANDHRA PRADESH |
9642238666
researchaditya26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMMITEE ADITYA MULTYSPECIALITY HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Brain Health |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LN22203 |
500 mg per day ,One capsule in the morning after breakfast for 30 days |
| Comparator Agent |
Placebo |
one capsule daily in the morning after breakfast for 30 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy male and female e-gamers (18 to 30 years of age with BMI range of 18 to 29 Kg per m2) who plays video games for 5 or more hours per week for 6 months prior to screening.
2.Adequate visual and auditory acuity to allow neuropsychological testing.
3.Subjects agreed to participate in 20 min e- Sports familiarization session at each visit.
4.Female subjects of childbearing potential must be using a medically acceptable form of birth control.
5.Subject agrees not to start any new supplements including Vitamins (Such as Folate, B12, B6 containing multivitamins) and herbal supplements during the course of the study.
6.Willing and able to sign informed consent and complete all tests and procedures as listed in the protocol.
7.Has not taken any type of medicine or herbal supplements in the past 3 months related to improve cognition or related functions.
8.Free from bipolar disorder and terminal illnesses such as cancer.
9.ECG without clinically significant abnormalities.
10.Subject should be a literate.
11.Results of screening are within normal range or considered not clinically significant by the Principal Investigator.
12. General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimers disease cannot be made by the site physician at the time of the screening visit.
|
|
| ExclusionCriteria |
| Details |
1.Subjects have a history of cognitive dysfunction.
2.Subject have known cardiovascular, metabolic and,or other diseases under the treatment (birth control is allowed).
3.Any clinically significant hepatic, renal, cardiovascular, pulmonary, gastrointestinal or haematological illness or unstable medical condition which could interfere with investigational supplement safety, or absorption, distribution, metabolism and excretion, or lead to difficulty complying with the protocol.
4.Any significant neurologic disease (other than suspected incipient Alzheimers disease), such as Parkinsons disease, stroke, TIAs, multi-infarct dementia, Huntingtons disease, head trauma, chronic CNS infection.
5.Clinically significant coagulopathy or vitamin K deficiency within the past two years prior to screening.
6.Subjects have known obstructive pulmonary disease or asthma or allergy to excipients of IP.
7.Subjects previously diagnosed with dementia or any neurological disease.
8.Subjects having post COVID symptoms or underwent treatment for COVID-19 within last 3 months or tested positive during the study will be excluded.
9.Subjects suffering from severe intrinsic sleep-related disorders such as sleep apnea, restless leg syndrome (RLS), narcolepsy.
10.History of major depression or another major psychiatric disorder within the past 6 months.
11.History of alcohol or substance abuse or dependence within the past year.
12.Subjects have any Sexually transmitted diseases (STD).
13.Uncontrolled hypertension and diabetes mellitus.
14.Subjects have abnormal blood pressure (Systolic greater than 140 and Diastolic greater than 100 mmHg).
15.Subjects have a recent major surgery or surgery scheduled in the next 4 to 5 weeks.
16.Any Abnormal clinical laboratory test results or vital signs considered clinically significant in the opinion of the Investigator.
17.Subjects with HIV Positive.
18.Indication of inability to make decisions regarding study participation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change from baseline to end of the study in scores in
Simple reaction time |
Day1 (baseline) Day7, Day15 and Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change from baseline to end of the study in Scores of Go-no-Go task.
2. Change from baseline to end of the study Scores of video games played in First person shooting (FPS) scenario
.
3. Change from baseline to end of the study in Scores of Profile of mood states Short form
.
4. Change from baseline to end of the study in Scores of Stroop color and word test (Divided attention ability and resistance to interference).
5.Change from baseline to end of the study in Berg’s-Card Sorting Tes
.
6. Change from baseline to end of the study in the Tower of London test.
7. Change from baseline to end of the study Matching to sample visual search for visual attention and acuity.
8. Change from baseline to end of the study in Serum levels of BDNF and Serotonin.
9.Change from baseline to end of the study in Heart rate (HR) during Spider shot, Capacitiy Ultimate, Trigger control, Sphere track. |
1. Day1 (baseline) Day7,Day15 and Day 30
2. Day1 (baseline) Day7,Day15 and Day 30
3. Day1 (baseline) Day7,Day15 and Day 30
4. Day1 (baseline) Day7,Day15 and Day 30
5. Day1 (baseline) Day7,Day15 and Day 30
6. Day1 (baseline) Day7,Day15 and Day 30
7. Day1 (baseline) Day7,Day15 and Day 30
8. Day1 (baseline)and Day 30
9. Day1 (baseline) Day7,Day15 and Day 30 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
08/02/2024 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of this study to evaluate influence of LN22203 supplementation on memory, e-sports performance and mood states of young adults.. A total of 50 male and female subjects of age between 18 and 30 years will be included in the study. Assessments of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-generated randomization list. The subjects will be assigned to either one of the study groups (LN22203 500mg or placebo) at 1:1 ratio. The participants will be instructed to take one capsule daily in the morning after breakfast for 30days. Apart from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal compositions safety and tolerability. The safety assessements of LN22203 will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention. |