| CTRI Number |
CTRI/2025/08/092829 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of herbal supplement in relieving dry eye symptoms |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled study to assess the efficacy of LN24214 in relieving dry eye symptoms |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LN/DE/LN24214/25 Version 01, 06-Jan-2025 |
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
520010
India |
| Phone |
08666636666 |
| 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
520010
India |
| Phone |
08666636666 |
| Fax |
08662475278 |
| Email |
prason@lailanutra.in |
|
|
Source of Monetary or Material Support
|
| Laila Nutra private limited Internal funding, 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
|
|
|
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 Pragnya Rao |
L V Prasad Eye Institute |
Room No: 206, Second Floor, Department of ophthalmology, Division of cornea, Kallam Anji Reddy Campus,L V Prasad Marg, Baniara Hills, Road No.: 2, Pin: 500034, India.
Hyderabad
TELANGANA |
04068102269
drpragnyarao@lvpei.org |
| Dr Madhu Uddaraju |
Dr Ramana Raju’s Vision Tree Super Speciality Eye Care Center |
#10-171/1/1, opp. Sri Kodanda
Ramalayam, Vishalakshi Nagar,Andhra Pradesh 530043, India.
Visakhapatnam
ANDHRA PRADESH |
8143972923
eyedrmadhu@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - INDUS Hospitals for Dr. Madhu Uddaraju |
Approved |
| L V Prasad Eye Institute Ethics Committee for Dr Pragnya Rao |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dry Eye Symptoms |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LN24214 100 mg/day |
One capsule daily in the morning after breakfast for 28 days |
| Intervention |
LN24214 200 mg/day |
One capsule daily in the morning after breakfast for 28 days |
| Comparator Agent |
Placebo |
One capsule daily in the morning after breakfast for 28 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and female subjects aged between 30 and 60 years experiencing visual fatigue or eye strain or presenting with symptoms suggestive of dry eye like irritation, foreign body (sandy) sensation, feeling of dryness, itching, non-specific ocular discomfort etc.
2.Subjects who daily use video game consoles or a PC, or operate VDT for at least 4 hours per day.
3.Subjects who have total corrected visual acuity of at least 1.0 for both eyes, if a refractive error exists, it should be properly corrected.
4.Subjects who meet all the following dry eye criteria in either of the eye
a)Schirmer’s test score without anesthesia between greater than or equal to 5 and less than or equal to 10 mm.
b)Ocular surface disease index (OSDI) scores for inclusion greater than or equal to 13 and less than or equal to 33.
c)Tear film break up time between greater than or equal to 5 sec and less than or equal to 10 sec.
d)Tear osmolarity range between greater than or equal to 316 milliosmole/L and less than or equal to 360 milliosmole/L.
e)Fluorescein corneal staining greater than or equal to 1 and less than or equal to 3 or More than 5 spots of corneal staining or greater than 9 conjunctiva spots or lid margin staining (greater than or equal to 2mm length & greater than or equal to 25 percent width) in at least one eye.
f)Subjects with positive result for MMP 9 as assessed by Quidels test.
5.Willing and able to read and sign informed consent and complete all tests and procedures as listed in the protocol.
6.Subject willing to maintain diet tracker, and agrees to maintain current dietary habits through end of study period.
7.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.
8.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 (less 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).
9.Has not taken carotenoid supplements (lutein, zeaxanthin, B-carotene, astaxanthin) for 3 months.
10.Has not taken fish oils/Omega oils for 2 weeks prior to study.
11.Free from any clinically significant disease that might interfere with the study evaluations.
12.Has not taken any type of medicine/pharmaceutical supplements/ herbal supplements for the past 3 months related to improve eye health.
13.ECG without clinically significant abnormalities.
14.Results of screening are within normal range or considered not clinically significant by the Principal Investigator.
15.Subjects willing to refrain from using eye drops during the study period.
|
|
| ExclusionCriteria |
| Details |
1.Diagnosis of dry eye disease
2.With the presence of severe dry eye syndrome with complications such as perforated corneal ulcer, uveitis, glaucoma, that may interfere with the evaluation of the subject’s dry eye syndrome in the investigator’s opinion.
3.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.
4.Subjects with Sjogren syndrome.
5.Contraindication of pupil dilatation in the study eye.
6.Early or Mature cataract or media opacification in either eye which limits an adequate view of fundus.
7.Not willing to stop the use of ocular topical medications, steroids, oral contraceptive pills, estrogens replacement therapy, any other medication and contact lenses during the intervention that may adversely affect the outcome of the study.
8.With diagnosed diabetes mellitus, rheumatoid arthritis, systemic lupus erythematous, which cause dry eye syndrome.
9.Subjects having history or signs of major systemic illness and with metabolic, renal, cardiac disorders.
10.Subject participating in another clinical trial or has received an investigational product or dietary supplement within thirty days prior to enrolment.
11.High alcohol intake (greater than 2 standard drinks per day), smokers (greater than 5 cigarettes per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.).
12.Who are pregnant, lactating, planning a pregnancy during the study.
13.Subjects with congenital malformations.
14.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.
15.Subjects have known obstructive pulmonary disease or asthma or allergy to excipients of IP.
16.Subjects having post COVID symptoms or underwent treatment for COVID-19 within last 6 months or tested positive during the study will be excluded.
17.Subjects having known history of any Sexually transmitted diseases (STD).
18.Subject have a recent (less than or equal to 6 months) major surgery or surgery scheduled in the next 4 to 5 weeks.
19.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
Modification(s)
|
| Outcome |
TimePoints |
Main effects for treatment over the study period
The Ocular Surface Disease Index (OSDI)
|
Screening & Randomization (V1)-Day 1, Follow up Visit (V2)-Day 7, Follow up Visit-(V3) Day 14 & Final Visit (V4)-Day 28 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Change in the scores before & after supplementation: Schirmer’s test
|
Screening & Randomization (V1)-Day 1, Follow up Visit (V2)-Day 7, Follow up Visit-(V3) Day 14 & Final Visit (V4)-Day 28 |
| Change in the scores before & after supplementation: Tear film break-up time (TBUT) using Fluoro Touch Fluorescein Sodium Ophthalmic Strips & ophthalmoscope |
Screening & Randomization (V1)-Day 1, Follow up Visit (V2)-Day 7, Follow up Visit-(V3) Day 14 & Final Visit (V4)-Day 28 |
| Change in the scores before & after supplementation: Tear osmolarity |
Screening & Randomization (V1)-Day 1,Follow up Visit-(V3) Day 14 & Final Visit (V4)-Day 28 |
| Change in the scores before & after supplementation: Tear meniscus height |
Screening & Randomization (V1)-Day 1, Follow up Visit (V2)-Day 7, Follow up Visit-(V3) Day 14 & Final Visit (V4)-Day 28 |
| Change in the scores before & after supplementation: MMP-9 in Quidel test |
Screening & Randomization (V1)-Day 1 & Final Visit (V4)-Day 28 |
| Change in the scores before & after supplementation: The national eye institute (NEI) visual function questionnaire (VFQ-25) |
Screening & Randomization (V1)-Day 1, Follow up Visit (V2)-Day 7, Follow up Visit-(V3) Day 14 & Final Visit (V4)-Day 28 |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
19/08/2025 |
| 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) |
Open to Recruitment |
|
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 is to evaluate the efficacy of LN24214 in relieving the dry eye symptoms. A total of 150 male and female subjects aged between 30 and 60 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 – 100 mg or LN24214 – 200 mg or placebo arms at 1:1:1 ratio. The subjects will be instructed to take One capsule daily in the morning after breakfast for 28 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. |