| CTRI Number |
CTRI/2025/04/085557 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Herbal] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical Study on Netramrit Capsules for Eye-Related Problems. |
|
Scientific Title of Study
|
A randomized, double blind, placebo controlled clinical study to evaluate the effects of a Netramrit Capsules in patients with eye-related problems. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/24-25/047 Version: 1.00; dated 09 December 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mayur Jawale |
| Designation |
Principal Investigator |
| Affiliation |
Atharvam Eye Hospital and Laser Surgery Center |
| Address |
2nd floor, C wing , 18, Latitude, 202, above darshan plywood, punawale pimpri- chinchwad maharashtra
Pune MAHARASHTRA 411033 India |
| Phone |
9850312435 |
| Fax |
- |
| Email |
drmayurj@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Amit Sharma |
| Designation |
AGM Production |
| Affiliation |
Pravek Kalp Private Limited |
| Address |
B-8, Sector 3, Noida (U.P)
Ghaziabad UTTAR PRADESH 201301 India |
| Phone |
9643123667 |
| Fax |
- |
| Email |
amitsharma@pravek.com |
|
Details of Contact Person Public Query
|
| Name |
Arijeet Bhattacharjee |
| Designation |
Sr. Manager Marketing |
| Affiliation |
Pravek Kalp Private Limited |
| Address |
B-8, Sector 3, Noida (U.P)
Ghaziabad UTTAR PRADESH 201301 India |
| Phone |
9643123667 |
| Fax |
- |
| Email |
arijeet@pravek.com |
|
|
Source of Monetary or Material Support
|
| Pravek Kalp Pvt. Ltd.
B-8, Sector 3, Noida (U.P) 201301 |
|
|
Primary Sponsor
|
| Name |
Pravek Kalp Pvt. Ltd. |
| Address |
B-8, Sector 3, Noida (U.P) 201301. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Mayur Jawale |
Atharvam Eye Hospital and Laser Surgery Center |
2nd /floor, C wing , 18, Latitude, 202, above darshan plywood, punawale pimpri- chinchwad maharashtra Pune MAHARASHTRA |
09850312435 - drmayurj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Lokmanya Medical Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H579||Unspecified disorder of eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Netramrit capsule |
Participants will receive a Netramrit capsule, administered
orally as one capsule twice daily with water or milk after a major meal for 90 days |
| Comparator Agent |
Placebo capsules |
Participants will receive a Placebo capsule administered orally
as 1 capsule twice daily with water or milk after a major meal for 90 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female participants aged between 18 to 40 years (both inclusive).
2. Participants who used the screen for more than 6 h daily.
3. Participants with eye fatigue symptom score greater than or equal to 3.
4. Willingness to participate in the study. |
|
| ExclusionCriteria |
| Details |
1.Participants with infectious or traumatic eye diseases;
2.Participant who had undergone eye surgery within 3 months;
3.Participants who had disease of the cardiovascular, cerebrovascular, liver, kidney, or hematopoietic system;
4.Participants having current ocular infection, history of laser in situ keratomileusis (LASIK), allergic conjunctivitis, contact lens wear, herpetic eye disease, diabetes and diabetes retinopathy or any other complications;
5.If the participant is allergic to any of the investigational product’s ingredients;
6.Pregnant women, lactating women, and women of childbearing potential not following adequate contraceptive measures, women who were found positive for urine pregnancy test;
7.Participation in any other therapeutic clinical study in the past 3 months, including participation in any other clinical trials;
8.Any condition that in the opinion of the investigator does not justify the participant’s inclusion in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Assessment of the Computerized Computer Vision Symptom scale.
2. Assessment of Eye Fatigue Symptoms using a 4-point scale (including eye swelling, eye soreness, photophobia, blurred vision, dry eye, foreign body sensation, tearing, and general discomfort related to eye fatigue) Each symptom was graded on a 4-point scale [0 = no symptoms, 1 = occasionally (less than or equal 1 time/d), 2 = sometimes (1–3 times/d), 3 = frequently (greater than 3 times/d)] .
3. Assessment of the National Eye Institute Visual Function Questionnaire (NEI VFQ-25) to assess the impact of treatment on overall quality of life and visual function. |
At screening, day 30, day 60, and day 90.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Adverse events profile
2. Compliance and tolerability of the investigational product . |
At baseline, day 30, day 60, and day 90.
|
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "61"
Final Enrollment numbers achieved (India)="61" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/05/2025 |
| Date of Study Completion (India) |
13/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Digital screen-induced stress is characterized by digital eye strain (which has symptoms of headache, dizziness, and eye strain), dry eye disease, myopia (nearsightedness), and disturbance in the sleep cycle. This leads to a deteriorating effect on overall quality of life and reduced cognition and overall work efficiency. Although current treatment suggests the use of cellulose-based eye drops and eye drops containing anti-inflammatory agents, also some studies have suggested preventive measures to reduce digital screen-induced stress. Eye- related problems, including fatigue, dryness, inflammation, and strain induced by prolonged digital screen exposure, are increasingly prevalent in today’s technology-driven world. Conventional treatments, such as artificial tears and ergonomic interventions, often provide temporary relief and do not address the root cause or improve overall eye health.
Netramitra Capsules, a novel Ayurvedic formulation, offers a holistic approach by combining classical and modern ingredients with potential therapeutic benefits. Saptamrit Lauha, Abhrak Bhasma, and Akik Bhasma are traditional formulations known to strengthen vision and alleviate eye discomfort. Aqueous extracts of Shatavari, Ashwagandha, and Giloy contribute adaptogenic, anti-inflammatory, and antioxidant properties, potentially addressing fatigue, dryness, and eye strain. Furthermore, processing with Triphala decoction enhances bioavailability and provides additional antioxidant and rejuvenating benefits.
This study aims to scientifically validate the efficacy and safety of Netramitra Capsules in alleviating symptoms such as headaches, dryness, and eye fatigue while enhancing vision clarity. A randomized, double-blind, placebo-controlled design ensures robust evidence generation, addressing the lack of clinical validation for such interventions. The findings could establish Netramitra Capsules as a natural, effective solution for improving eye health and quality of life in individuals with digital eye strain.
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