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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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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