Health Condition 1: H579- Unspecified disorder of eye and adnexa
Conditions
Interventions
Intervention1: 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
Intervention2: Placebo
Sponsors
Pravek Kalp Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: At screening, day 30, day 60, and day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events profile 2. Compliance and tolerability of the investigational product .Timepoint: At baseline, day 30, day 60, and day 90. | — |
Countries
India
Contacts
Public ContactArijeet Bhattacharjee
Pravek Kalp Private Limited
Outcome results
None listed