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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05211063
Other study ID # PHARMACTIVE-21TPA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 21, 2022
Est. completion date May 5, 2023

Study information

Verified date May 2023
Source University of Alicante
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date May 5, 2023
Est. primary completion date December 27, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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.

Study Design


Intervention

Dietary Supplement:
Saffron extract (Crocus sativus)
Daily intake of one tablet for 42 days.
Placebo
Daily intake of one tablet for 42 days.

Locations

Country Name City State
Spain University of Alicante San Vicente Del Raspeig Alicante

Sponsors (2)

Lead Sponsor Collaborator
University of Alicante Pharmactive Biotech Products S.L.U

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Change from baseline quality of life related to health at 42 days Measured with Short Form-36 survey (SF-36). It evaluates 36 items that form 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health). The scores are weighted sums of the questions in each section. The score ranges from 0 to 100. Lower scores = more disability, higher scores = less disability. 0 (baseline) and 42 days
Secondary Satisfaction question A single satisfaction question. Participants must respond by selecting a number from a Likert scale from 0 to 5. Last visit (42 day)
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