Status:
COMPLETED
Effects of CROCUVIS+® on Computer Vision Syndrome, Sleep and Mood Disorders
Lead Sponsor:
University of Alicante
Collaborating Sponsors:
Pharmactive Biotech Products S.L.U
Conditions:
Computer Vision Syndrome
Sleep Disorder
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
Previous research has shown the efficacy of CROCUVIS+® dietary supplement, based on saffron extract, in the proper functioning of visual health, for example, against the development of glaucoma. The m...
Eligibility Criteria
Inclusion
- CVS-Q© score ≥6.
- Age between 18 and 40 years (both inclusive).
- Exposure to digital devices 4 hours a day, at least five days a week or more and maintain the same level of exposure throughout the study period.
Exclusion
- Monocular corrected distance visual acuity \>0.0 LogMAR.
- Ocular pathology under treatment at the time of the study.
- Previous ocular surgery that could affect the tear film or the ocular surface.
- Ocular Surface Disease Index (OSDI) questionnaire score ≥13.
- Previous diagnosis or history of dry eye syndrome and/or blepharitis.
- Regular (daily) use of rigid or soft contact lenses ≥3 days a week.
- Regular use of any ocular lubricant.
- History of oral intake of dietary supplements, with or without herbal ingredients, intended to contribute, maintain or reduce the risk of suffering diseases related to visual function, mood or sleep within the four weeks before the study enrollment.
- Systemic disease:
- Uncontrolled hypertension (systolic/diastolic blood pressure \>140/90 mmHg).
- Uncontrolled diabetes mellitus (fasting blood glucose level \>180 mg/dL).
- Rheumatoid arthritis.
- Tumor disease.
- Active hepatitis (type B and C).
- Active infectious disease.
- Kidney disease that compromises diuresis.
- Current systemic treatment or in the last 3 months with drugs that may interfere with the results, for example:
- Opioids.
- Antipsychotics.
- Antibiotics (tetracyclines, sulfonamides)
- Antiarthritic drugs (hydroxychloroquine)
- Hypotensive drugs (beta-blockers)
- Anticoagulants (heparin, warfarin, or clopidogrel)
- Antidepressants (such as fluoxetine, among others)
- Hypnotics (eg, benzodiazepines)
- Habitual smoker and/or alcohol drinker. More than 3 cigarettes per day and/or more than 3 Standard Drink Units (SDU) per week, including weekends. SDU is defined as the consumption of 10 ml of alcohol.
- Regular job with rotating shifts including night shift in the last month (including weekends).
- Pregnancy or breastfeeding (also excludes recent pregnancy within the last 3 months) and women planning to become pregnant.
- Participation in another clinical trial in the last 3 months.
- Take any type of dietary supplements with botanical components in the last month.
Key Trial Info
Start Date :
October 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05211063
Start Date
October 21 2022
End Date
May 5 2023
Last Update
May 11 2023
Active Locations (1)
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1
University of Alicante
San Vicent del Raspeig, Alicante, Spain, 03690