Effects of CROCUVIS+® on Computer Vision Syndrome, Sleep and Mood Disorders

University of Alicante

Status

Completed

Conditions

Sleep Disorder

Computer Vision Syndrome

Mood Disorders

Treatments

Dietary Supplement: Saffron extract (Crocus sativus)

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05211063

PHARMACTIVE-21TPA

Details and patient eligibility

About

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 main objective of this study is to evaluate the efficacy of CROCUVIS® in computer vision syndrome, sleep and mood disorders in a sample of university students who use digital devices.

Enrollment

100 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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:
1. Uncontrolled hypertension (systolic/diastolic blood pressure >140/90 mmHg).
2. Uncontrolled diabetes mellitus (fasting blood glucose level >180 mg/dL).
3. Rheumatoid arthritis.
4. Tumor disease.
5. Active hepatitis (type B and C).
6. Active infectious disease.
7. Kidney disease that compromises diuresis.
Current systemic treatment or in the last 3 months with drugs that may interfere with the results, for example:
1. Opioids.
2. Antipsychotics.
3. Antibiotics (tetracyclines, sulfonamides)
4. Antiarthritic drugs (hydroxychloroquine)
5. Hypotensive drugs (beta-blockers)
6. Anticoagulants (heparin, warfarin, or clopidogrel)
7. Antidepressants (such as fluoxetine, among others)
8. 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.