| CTRI Number |
CTRI/2020/08/027368 [Registered on: 26/08/2020] Trial Registered Prospectively |
| Last Modified On: |
23/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
AÂ study to determine the efficacy and tolerability of LN19184 to improve cognition in adults. |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and tolerability of LN19184 to improve cognitive function in ageing human volunteers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LN/CF/LN19184/19 Version 2.0 Dated 13-June-2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Vijay Bhaskara Gupta |
| Designation |
Assistant Professor Psychiatry |
| Affiliation |
Government Medical College and Government General Hospital |
| Address |
OPD Block, ,Room no 3, 1st floor, Dept of Psychiatry
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
9912320517 |
| Fax |
|
| Email |
rimsresearch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Golakoti Trimurthulu |
| Designation |
Senior Vice President Technical |
| Affiliation |
Laila Nutraceuticals |
| Address |
Laila Nutraceuticals,Room No 13 Ground Floor R&D Block Surevy No 181 by 2 JRD Tata Industrial Estate Kanuru Vijayawada
Krishna
ANDHRA PRADESH
520007
India |
| Phone |
08666636666 |
| Fax |
08662546216 |
| Email |
drgt@lailanutra.in |
|
Details of Contact Person
Public Query
|
| Name |
Alluri Venkata Krishna Raju |
| Designation |
General Manager |
| Affiliation |
Laila Nutraceuticals |
| Address |
Laila Nutraceuticals Room No 17 Ground Floor R&D Block Surevy No 181 by 2 JRD Tata Industrial Estate Kanuru Vijayawada
Krishna
ANDHRA PRADESH
532001
India |
| Phone |
08666636666 |
| Fax |
08662546216 |
| Email |
avkr@lailanutra.in |
|
|
Source of Monetary or Material Support
|
| Laila Nutraceuticals R&D Block Surevy No 181 by 2 JRD Tata Industrial Estate Kanuru Vijayawada Krishna District ANDHRA PRADESH 520007 India |
|
|
Primary Sponsor
|
| Name |
Laila Nutraceuticals |
| Address |
40-15-14, Brindavan Colony, Labbipet Vijayawada-520 010 Andhra Pradesh India |
| Type of Sponsor |
Other [Nutraceuticals Industry] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashsih Kumar Gupta |
Arogya JanaSeva Kendra |
Room no 2, Ground Floor, Tadiya near Amanpuri colony, Old RTO Sarnath Varanasi 221007
Varanasi
UTTAR PRADESH |
9838602582
Ashishkgmcbhu07@gmail.com |
| Dr S Vijay Bhaskara Gupta |
Government Medical College and Government General Hospital |
OPD Block, Room no 3, 2nd floor, Dept of Psychiatry
Srikakulam
ANDHRA PRADESH |
9912320517
rimsresearch@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Government Medical College & Government General Hospital |
Approved |
| Opal Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Cognition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LN19184 |
One capsule (300mg) daily in the morning after breakfast for 120 days |
| Comparator Agent |
Placebo |
One capsule (300mg) daily in the morning after breakfast for 120 days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Males and females of 40-65 years of age with BMI range of 18 to 29 Kg/m2.
2)Subjects with a screening Mini-Mental State Examination (MMSE) score 19-30.
3)Individuals with subjective memory complaints.
4)Individuals with a score of 0-7 in Hamilton depression rating scale.
5)Female subjects of childbearing potential must be using a medically acceptable form of birth control. Post-menopausal women for at least 1 year or had a hysterectomy and/or bilateral oophorectomy.
6)Adequate visual and auditory acuity to allow neuropsychological testing.
7)Subject agrees not to start any new therapies including Vitamin (Such as Folate, B12, B6 containing multivitamins) and herbal supplements during the course of the study
8)Willing and able to sign informed consent and complete all tests and procedures as listed in the protocol.
9)Has not taken any type of medicine or herbal supplements in the past 3 months related to study indication
10)Free from bipolar disorder and terminal illnesses such as cancer.
11)ECG without clinically significant abnormalities
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.
13)Subject should be a literate.
|
|
| ExclusionCriteria |
| Details |
1) Any significant neurologic disease (other than suspected incipient Alzheimers disease, such as Parkinson disease, stroke, TIAs, multi infarct dementia, Huntingtons disease, head trauma, chronic CNS infection
2)Subjects diagnosed with sleep apnea or related disorders.
3)History of major depression or another major psychiatric disorder within the past 6 months.
4)Any clinically significant hepatic, renal, cardiovascular, pulmonary, gastrointestinal or hematological 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.
5)Uncontrolled hypertension and diabetes mellitus.
6)Clinically significant obstructive pulmonary disease or asthma.
7)Clinically significant liver disease, coagulopathy or vitamin K deficiency within the past two years prior to screening.
8)History of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
9)History of alcohol or substance abuse or dependence within the past year.
10)Any Abnormal clinical laboratory test results or vital signs considered clinically significant in the opinion of the Investigator
11)Subjects with HIV Positive.
12)Indication of inability to make decisions regarding study participation.
13)During the course of the study, participants were requested not to change their dietary habits.
14)Disability that may prevent the subject from completing all study requirements (e.g. blindness, deafness, severe language difficulty, etc.)
15)Women who are pregnant, lactating or planning to become pregnant during the study period.
16)Enrollment in another investigational study or intake of investigational drug within the previous three months.
17)Suspected or known allergy to any components of the study supplement.
18)Subjects with history of thyroid dysfunction.
19)Any condition (e.g. epilepsy) which in the opinion of the investigator makes the patient unsuitable for inclusion
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change from baseline to end of the study in immediate and delayed recall |
Screening, Day 1, Day 15, Day 30, Day 60, Day 90 and Day 120 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change from baseline to end of the study in reaction time |
Screening, Day 1, Day 15, Day 30, Day 60, Day 90 and Day 120 |
| Change from baseline to end of the study in attention and vigilance |
Screening, Day 1, Day 15, Day 30, Day 60, Day 90 and Day 120 |
| Change from baseline to end of the study in executive function |
Screening, Day 1, Day 15, Day 30, Day 60, Day 90 and Day 120 |
| Change from baseline to end of the study in working memory |
Screening, Day 1, Day 15, Day 30, Day 60, Day 90 and Day 120 |
| Change from baseline to end of the study in self assessed sleep scale |
Screening, Day 1, Day 15, Day 30, Day 60, Day 90 and Day 120 |
| Change from baseline to end of the study in Visual episodic memory |
Screening, Day 1, Day 15, Day 30, Day 60, Day 90 and Day 120 |
| Change from baseline to end of the study in Brain derived serum bio-marker like BDNF |
Screening and Day 120 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="2" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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, double-blind, placebo-controlled 2 arm clinical study to evaluate the efficacy and tolerability of LN19184 to improve cognitive function in ageing human volunteers, in which the randomized subjects will administered with the study supplement or Placebo orally once daily for 120 days |
|