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Several recent clinical trials have highlighted the potential role of Product in promoting eye health.product whose structural and functional characteristics make it a promising bioactive compound in the prevention of several human diseases as well as in the maintenance of a good health status. it might relieve eyestrain in people using computer monitors as suggested who conducted a double-blind randomized clinical trial by enrolling visual display terminal workers and prescribed them product or placebo. Study outcomes were objectively evaluated by using a proper instrumentation to measure eye muscle endurance. Subjects receiving Product experienced a significant relief from eyestrain compared to the placebo group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAEP-01 | Active Comparator | Dose: 1 capsule Route: orally for 84 ± 3 days Regimen: one capsule beforebreakfast (preferably with milk/butter/ghee) |
|
| Placebo | Placebo Comparator | Dose: 1 capsule Route: orally for 84 ± 3 Regimen: one capsule before breakfast (preferably with milk/butter/ghee) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAEP-01 | Other | Dose: 1 capsule Route: orally for 84 ± 3 days Regimen: one capsule before breakfast (preferably with milk/butter/ghee) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Computer Vision Syndrome-Questionnaire | To assess the effect of 84 days of IP consumption on severity of the symptoms using Computer Vision Syndrome-Questionnaire.The two levels of intensity, or strength of the symptom, will be graded similarly, on a scale of 1 to 2 points, where moderate = 1 and intense = 2. In the analysis, a symptom rated as never occurring will be treated as 0 (none) on the intensity scale. The overall assessment will be conducted by obtaining the total score for DES. The result of frequency X intensity will be recorded as: 0 = 0; 1 or 2 = 1; 4 = 2. If the total score is ≥ 6 points, the participant will be considered to be suffering from digital eye strain. It is further categorized as mild DES (score = 6-12), moderate DES (score = 13-18), and severe DES (score = 19-32) | Screening before playing videogames on digital device |
| Computer Vision Syndrome-Questionnaire | To assess the effect of 84 days of IP consumption on severity of the symptoms using Computer Vision Syndrome-Questionnaire.The two levels of intensity, or strength of the symptom, will be graded similarly, on a scale of 1 to 2 points, where moderate = 1 and intense = 2. In the analysis, a symptom rated as never occurring will be treated as 0 (none) on the intensity scale. The overall assessment will be conducted by obtaining the total score for DES. The result of frequency X intensity will be recorded as: 0 = 0; 1 or 2 = 1; 4 = 2. If the total score is ≥ 6 points, the participant will be considered to be suffering from digital eye strain. It is further categorized as mild DES (score = 6-12), moderate DES (score = 13-18), and severe DES (score = 19-32) | Day 0 before playing videogames on digital device |
| Computer Vision Syndrome-Questionnaire | To assess the effect of 84 days of IP consumption on severity of the symptoms using Computer Vision Syndrome-Questionnaire.The two levels of intensity, or strength of the symptom, will be graded similarly, on a scale of 1 to 2 points, where moderate = 1 and intense = 2. In the analysis, a symptom rated as never occurring will be treated as 0 (none) on the intensity scale. The overall assessment will be conducted by obtaining the total score for DES. The result of frequency X intensity will be recorded as: 0 = 0; 1 or 2 = 1; 4 = 2. If the total score is ≥ 6 points, the participant will be considered to be suffering from digital eye strain. It is further categorized as mild DES (score = 6-12), moderate DES (score = 13-18), and severe DES (score = 19-32) |
| Measure | Description | Time Frame |
|---|---|---|
| Asthenopia Visual Fatigue Likert scale | The participant will respond digitally a relevant present condition from None (0), Very Mild (1), Mild (2), Moderate (3), Very Moderate (4), and Severe (5) and the total score will be calculated | Day 0, day 14, day 28, day 56 and day 84. |
| Immunitythe subject felt sick will be documented in sick diary along with the concomitant medication used (dose and frequency will be captured). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Shalini Srivastava, MD medicine | Vedic Lifesciences Pvt. Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aman Hospital and Research Center | Ahmedabad | Guijarat | 390021 | India | ||
| Wavikar Eye Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40014233 | Derived | Hecht KA, Marwah M, Wood V, Nishida Y, Bach AE, Gerson J, Hom MM, Schnackenberg J, Raote S, Srivastava S, Negi P, Caston E. Astaxanthin (AstaReal(R)) Improved Acute and Chronic Digital Eye Strain in Children: A Randomized Double-Blind Placebo-Controlled Trial. Adv Ther. 2025 Apr;42(4):1811-1833. doi: 10.1007/s12325-025-03125-7. Epub 2025 Feb 27. |
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| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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CAEP-01, Placebo Dose: 44 mg/day Route: orally for 84 ± 3 days Regimen: one capsule before breakfast (preferably with milk/butter/ghee)
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Sealed envelop, double-blind randomized
| Placebo | Other | Dose: 1 capsule Route: orally for 84 ± 3 days Regimen: one capsule before breakfast (preferably with milk/butter/ghee) |
|
| Day 14 before playing videogames on digital device |
| Computer Vision Syndrome-Questionnaire | To assess the effect of 84 days of IP consumption on severity of the symptoms using Computer Vision Syndrome-Questionnaire.The two levels of intensity, or strength of the symptom, will be graded similarly, on a scale of 1 to 2 points, where moderate = 1 and intense = 2. In the analysis, a symptom rated as never occurring will be treated as 0 (none) on the intensity scale. The overall assessment will be conducted by obtaining the total score for DES. The result of frequency X intensity will be recorded as: 0 = 0; 1 or 2 = 1; 4 = 2. If the total score is ≥ 6 points, the participant will be considered to be suffering from digital eye strain. It is further categorized as mild DES (score = 6-12), moderate DES (score = 13-18), and severe DES (score = 19-32) | Day 28 before playing videogames on digital device |
| Computer Vision Syndrome-Questionnaire | To assess the effect of 84 days of IP consumption on severity of the symptoms using Computer Vision Syndrome-Questionnaire.The two levels of intensity, or strength of the symptom, will be graded similarly, on a scale of 1 to 2 points, where moderate = 1 and intense = 2. In the analysis, a symptom rated as never occurring will be treated as 0 (none) on the intensity scale. The overall assessment will be conducted by obtaining the total score for DES. The result of frequency X intensity will be recorded as: 0 = 0; 1 or 2 = 1; 4 = 2. If the total score is ≥ 6 points, the participant will be considered to be suffering from digital eye strain. It is further categorized as mild DES (score = 6-12), moderate DES (score = 13-18), and severe DES (score = 19-32) | Day 56 before playing videogames on digital device |
| Computer Vision Syndrome-Questionnaire | To assess the effect of 84 days of IP consumption on severity of the symptoms using Computer Vision Syndrome-Questionnaire.The two levels of intensity, or strength of the symptom, will be graded similarly, on a scale of 1 to 2 points, where moderate = 1 and intense = 2. In the analysis, a symptom rated as never occurring will be treated as 0 (none) on the intensity scale. The overall assessment will be conducted by obtaining the total score for DES. The result of frequency X intensity will be recorded as: 0 = 0; 1 or 2 = 1; 4 = 2. If the total score is ≥ 6 points, the participant will be considered to be suffering from digital eye strain. It is further categorized as mild DES (score = 6-12), moderate DES (score = 13-18), and severe DES (score = 19-32) | Day 84 before playing videogames on digital device |
the number of days when the subject felt sick will be documented in sick diary along with the concomitant medication used (dose and frequency will be captured). Immunity as assessed by the number of sick days reported for each participant during the treatment period, as compared to the placebo |
| Day 14, Day 28, Day 56 and Day 84 |
| Immunity of participan has contracted the common cold/flu | Immunity as assessed by the number of times participant has contracted the common cold/flu during the treatment period, as compared to the placebo. | Day 14, Day 28, Day 56 and Day 84 |
| Thane |
| Maharashtra |
| 400601 |
| India |
| Jaipur National University Institute for Medical Sciences & Research Centre | Jaipur | Rajasthan | 302017 | India |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |