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

NCT05211063 | Completed

• 1 other identifier: PHARMACTIVE-21TPA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Computer Vision Syndrome; Sleep Disorder; Mood Disorders

Outcome Measures

Primary Outcomes (3)

• Change from baseline computer vision syndrome at 14, 28 and 42 days

  Measured with the Computer Vision Syndrome Questionnaire (CVS-Q©). It evaluates the frequency and intensity with which 16 symptoms are perceived over the time of use of digital devices. The score ranges from 0 to 32; computer vision syndrome is considered ≥6. The higher score a subject gained, the worsen ocular condition he/she experienced.

  0 (baseline), 14, 28 and 42 days

• Change from baseline sleep disorders at 14, 28 and 42 days

  Measured with the Insomnia Severity Index (ISI). It evaluates 7 items. The score ranges from 0 to 28 (worst). Each item is evaluated on a 5-point Likert scale (from 0 to 4). The final score is obtained from the sum of the responses of all items; insomnia is considered ≥8.

  0 (baseline), 14, 28 and 42 days

• Change from baseline mood at 14, 28 and 42 days

  Measured with the Profile of Mood States (POMS). It evaluates 58 items that form 6 factors (tension, depression, anger, vigour, fatigue, and confusion). The score ranges from 68 to 300 (worst mood). Each item is evaluated with a 5-point Likert scale (from 0 to 4). The score of each factor is obtained from the sum of the responses of all the items that define it. Total Mood Disturbance = 100+ (Tension + Depression + Anger + Fatigue + Confusion) - Vigour

  0 (baseline), 14, 28 and 42 days

Secondary Outcomes (2)

• Change from baseline quality of life related to health at 42 days

  0 (baseline) and 42 days

• Satisfaction question

  Last visit (42 day)

Study Arms (2)

Saffron extract (Crocus sativus)

EXPERIMENTAL

Daily intake of one tablet for 42 days.

Dietary Supplement: Saffron extract (Crocus sativus)

Placebo

PLACEBO COMPARATOR

Daily intake of one tablet for 42 days. This tablet is organoleptically indistinguishable from the experimental tablet.

Dietary Supplement: Placebo

Interventions

Saffron extract (Crocus sativus) DIETARY_SUPPLEMENT

Daily intake of one tablet for 42 days.

Saffron extract (Crocus sativus)

Placebo DIETARY_SUPPLEMENT

Daily intake of one tablet for 42 days.

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alicante: lead
• Pharmactive Biotech Products S.L.U: collaborator

Study Sites (1)

University of Alicante

San Vicent del Raspeig, Alicante, 03690, Spain

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Mood Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior lecturer, PhD

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: January 27, 2022
• Study Start: October 21, 2022
• Primary Completion: December 27, 2022
• Study Completion: May 5, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)