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CTRI Number  CTRI/2026/01/102401 [Registered on: 29/01/2026] Trial Registered Prospectively
Last Modified On: 22/08/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study
Modification(s)  		 Efficacy of herbal supplement in reducing digital eye strain. 
Scientific Title of Study
Modification(s)  		 A randomized, double-blind, placebo-controlled study to assess the efficacy of LN24214 in adults with digital eye strain  
Trial Acronym  NIL 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
LN/DES/LN24214/26 Version 02, 02 Apr 2026   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Prason Kumar J 
Designation  Overall Trial Coordinator 
Affiliation  Laila Nutra Private Limited 
Address  First Floor, R&D Division, Clinical Research Department, Survey No. 181/2,181/3,181/4B, JRD Tata Industrial Estate, Kanuru, Vijayawada.

Krishna
ANDHRA PRADESH
520007
India 
Phone  08662464445  
Fax  08662475278  
Email  prason@lailanutra.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Golakoti Trimurtulu 
Designation  Senior Vice-president-Technical 
Affiliation  Laila Nutra Private Limited 
Address  Ground Floor, R&D Division, Survey No. 181/2,181/3,181/4B, 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  Mr Prason Kumar J 
Designation  Manager-Clinical Research 
Affiliation  Laila Nutra Private Limited 
Address  First Floor, R&D Division, Clinical Research Department, Survey No. 181/2,181/3,181/4B, JRD Tata Industrial Estate, Kanuru, Vijayawada.

Krishna
ANDHRA PRADESH
520007
India 
Phone  08666636666  
Fax  08662475278   
Email  prason@lailanutra.in  
 
Source of Monetary or Material Support  
Laila Nutra private limited, Survey No. 181/2,181/3,181/4B, JRD Tata Industrial Estate, Kanuru, Vijayawada, Pin: 520007, Andhra Pradesh, India.  
 
Primary Sponsor  
Name  Laila Nutra private limited 
Address  Survey No. 181/2,181/3,181/4B, JRD Tata Industrial Estate, Kanuru, Vijayawada, Pin: 520007, Andhra Pradesh, India. 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr U Vivekanand  Alluri Sitarama Raju Academy of Medical Sciences  Department of Ophthalmology, First Floor, Room No.: 01, Malkapuram, Eluru, NH 5, 534005, India.
West Godavari
ANDHRA PRADESH 		 08331015073

academicresearch@asram.in 
Dr Madhu Uddaraju   Dr Ramana Rajus Vision Tree Super Speciality Eye Care Center  Department of Ophthalmology, Ground Floor, Room No.: 01, 10-171/1/1, opp. Sri Kodanda Ramalayam, Vishalakshi Nagar, 530043, India.
Visakhapatnam
ANDHRA PRADESH 		 8143972923

eyedrmadhu@gmail.com 
Dr Aparna Potluri  Medex Superspeciality Eye Care Hospital  Department of Ophthalmology, First Floor, Room No: 01, D. NO.4-4-117, 4th Ln, Chandramouli Nagar, 522007, India.
Guntur
ANDHRA PRADESH 		 08499829999

drmedex74@gmail.com  
Dr G Madhavi Latha  Sai Chaitanya Eye Care  Department of Ophthalmology, First Floor, Room No: 01, D No: 45-4-190/1, Sivalayam Veedhi, Kothapet, 522001, India.
Guntur
ANDHRA PRADESH 		 08632220395

gmadhavilatha71@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Institutional Ethics Committee INDUS Hospitals for Dr. Madhu Uddaraju   Submittted/Under Review 
Institutional Ethics Committee - Aditya Multispeciality Hospital for Dr. G. Madhavi Latha  Approved 
Institutional Ethics Committee - Aditya Multispeciality Hospital for Dr. G.Madhavi Latha  Approved 
Institutional Ethics Committee - Alluri Sitarama Raju Ethics Committee, Alluri Sitarama Raju Academy of Medical Sciences for Dr. U. Vivekanand  Approved 
Institutional Ethics Committee - NUHA Hospitals for Dr. Aparna Potluri   Approved 
Institutional Ethics Committee - NUHA Hospitals for Dr. Aparna Potluri  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Digital Eye Strain (DES) 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LN24214 200 mg/day  One capsule daily in the morning after breakfast for 42 days  
Comparator Agent  Placebo  One capsule daily in the morning after breakfast for 42 days 
 
Inclusion Criteria
Modification(s)  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Male and female adults age between 30-50 years with BMI of 20 to 29 kg per meter square.
2. Self-reported average daily digital screen time of greater than or equal to 4 hours per day for the last greater than or equal to 3 months.
3. Participants who have complained of eye strain on use of digital device.
4. Participant with CVS-Q score between 8 and 19.
5. Best Corrected Visual Acuity BCVA of 20/20.
6. Participants with less than or equal to12.5 cm and greater than or equal to 6 cm on Near Point Accommodation NPA test.
7. Participant agrees to maintain a record of screen time use throughout the study.
8. Willing to participate in the study and was able to read and write.
9. Sign informed consent and complete all tests and procedures as listed in the protocol.
10. Females of childbearing potential who are sexually active must agree to use adequate non-hormonal contraception during the study.
11. Subject willing to maintain diet tracker and agrees to maintain current dietary habits through end of study period.
12. Subject agrees not to consume any supplements including beverages, herbal, vitamins Such as Folate, B12, and B6 containing multivitamins, drugs including OTC medications pain relievers, antihistamines, other allergy medications, cold/ flu remedies, prescriptions, recreational drugs and nutritional products during the study period.
13. Subject agrees to limit their intake of coffee less than or equal to 4 cups a day, tea less than or equal to 3 cups a day, cola greater than or equal to 3 cups a day, energy drinks less than or equal to 350 ml or 1.4 cans, chocolate less than 10 gms of dark chocolate.
14. Has not taken carotenoid supplements lutein, zeaxanthin, B-carotene, astaxanthin for 3 months.
15. Has not taken fish oils/omega oils for 2 weeks prior to study, and agrees to refrain for study duration.
16. Free from any clinically significant disease that might interfere with the study evaluations.
17. Has not taken any type of medicine/pharmaceutical supplements/ herbal supplements for the past 3 months related to improve eye health.
18. ECG without clinically significant abnormalities.
19. Results of screening are within normal range or considered not clinically significant by the Principal Investigator.
20. Subjects willing to refrain from using eye drops during the study period.

 
 
ExclusionCriteria 
Details  1. Participants who wear contact lenses.
2. Participants with any diagnosed ocular motility disorder or accommodative/binocular vision issues.
3. Participants who are colour-blind.
4. Participant on any retinols and carotenoid supplements.
5. Participants who have immunosuppressive disorders or are taking immunosuppressive medication.
6. Participants with Atopy, allergic disorders and Anaemia.
7. Participants who underwent Ophthalmic laser treatment less than 3 months.
8. Women who are pregnant, lactating or planning to become pregnant during the study duration.
9. Subjects with a high blood pressure at screening systolic blood pressure greater than or equal to 140 mmHg or diastolic blood pressure greater than or equal to 90 mmHg and fasting blood glucose levels greater than 125 mg/dl.
10. Systemic disease associated with dry eye or diagnosed with dry eye disease or Blepharitis.
11. Having liver chronic liver failure, cirrhosis, all types of hepatitis, kidney chronic kidney disease, haemodialysis or haematological anaemia, thalassemia, haemophilia disorders.
12. Psychiatric disease or mental retardation bipolar disorder, depression, schizophrenia.
13. Cancer all types, and endocrine disorders Cushings disease, gigantism and hyperthyroidism.
14. Subjects with the presence of severe dry eye syndrome, or with complications such as perforated corneal ulcer, uveitis, glaucoma, that may interfere with the evaluation of the subjects dry eye syndrome in the investigators opinion.
15. Subjects with herpetic eye disease, history of lacrimal gland infections, laser in situ keratomileusis and with any ocular trauma or surgery that may affect corneal sensitivity and/or normal tear distribution e.g., cataract surgery, refractive surgery within the 6 previous months to study inclusion.
16. Subjects with Sjogren syndrome.
17. Subjects with contraindication of pupil dilatation in the study eye.
18. Early or Mature cataract or media opacification in either eye which limits an adequate view of fundus.
19. Not willing to stop the use of ocular topical medications, steroids, any other medication and contact lenses during the intervention that may adversely affect the outcome of the study.
20. Subjects with diagnosed diabetes mellitus, rheumatoid arthritis, systemic lupus erythematous, which cause dry eye syndrome.
21. Subjects having history or signs of major systemic illness and with metabolic, renal, cardiac disorders.
22. Subject participating in another clinical trial or has received an investigational product or dietary supplement within thirty days prior to enrolment.
23. High alcohol intake greater than 2 std drinks per day, smoking cigarettes or use of recreational drugs such as cocaine, methamphetamine, marijuana, etc.
24. Subjects with congenital malformations.
25. Subject has any medical condition or uses any medication, nutritional product, protein powder, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk.
26. Subjects have known obstructive pulmonary disease or asthma or allergy to excipients of IP.
27. Subjects having post COVID symptoms or underwent treatment for COVID-19 within last 6 months or tested positive during the study will be excluded.
28. Subjects having known history of any Sexually transmitted diseases STD.
29. Subjects have a recent less than or equal to 6 months major surgery or surgery scheduled in the next 4-5 weeks.
30. Subject has any findings on physical examination or results of laboratory analyses, which in the opinion of the investigator, are clinically significant deviations from the normal laboratory ranges i.e., laboratory values greater than 2x the upper limit of normal values. 
 
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 the baseline to end of the study period in:
Scores of Computer vision syndrome (CVS) before digital exposure.
 		 Screening & Randomization (V1)-Day 1, Follow up Visit (V2)-Day 21 & Final Visit (V3)-Day 42
 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Change in the scores of below tests before & after supplementation

Visual fatigue scale questionnaire before & after 60 minutes of digital exposure.
 		 Day 1, Day 21, & Day 42 
Change in the scores of below tests after 60 Minutes of Digital Exposure
Visual Acuity
Near Point Accommodation
Near Exophoria
Dry Eye Severity using the Schirmer I Test
Pupil Size
Stereopsis
Blinking Frequency
Instant Ocular Symptoms Survey
 		 Day 1, Day 21, & Day 42 
Change in the scores of below tests before 60 Minutes of Digital Exposure
Ocular Comfort Index
 		 Day 1, Day 21, & Day 42 
 
Target Sample Size
Modification(s)  		 Total Sample Size="120"
Sample Size from India="120" 
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)   24/08/2026 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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
Modification(s)  

The purpose of this study is to evaluate the efficacy of LN24214 in reducing digital eye strain. A total of 120 male and female subjects aged between 30-50 years will be included in the study. Assessment 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 LN24214 - 200 mg or placebo arms at 1:1  ratio. The subjects will be instructed to take One capsule daily in the morning after breakfast for 42 days. 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 assessment of the LN24214 will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention.

 
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