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NOT YET RECRUITING

NCT07324759

Clinical Study to Assess Safety, Effectiveness and In-Use Tolerability of Saffron Extract Capsules for Improving Skin Health and Reducing Signs of Aging on Healthy Adult Male and Female Subjects.

Sponsor: NovoBliss Research Pvt Ltd

View on ClinicalTrials.gov

Summary

This is a randomized, double-blind, comparative, two-arm, prospective, interventional, multi-centre clinical study to evaluate the safety, efficacy, and in-use tolerability of test products, standardized saffron extract capsules, on skin rejuvenation and age-defying benefits in healthy adult male and female subjects.

Official title: Effect of Saffron Extract Capsule Supplement on Skin Rejuvenation and Anti-Ageing in Healthy Adult Male and Female Subjects: Randomised, Double-Blind, Two-Group, Prospective, Multi-Centre Exploratory Study

Key Details

Gender

All

Age Range

30 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-01-01

Completion Date

2026-05-30

Last Updated

2026-01-07

Healthy Volunteers

Yes

Conditions

Wrinkles Fine Lines Hyperpigmentation Dark Spots

Interventions

DIETARY_SUPPLEMENT

Standardized Saffron Extract (Crocus Sativus L) 10 mg Capsule

Mode of Usage: Administer one capsule once daily after meal, ideally at the same time each day to maintain consistency in absorption. Swallow the capsule whole with a full glass of water; do not crush, break, or chew the capsule. Frequency: Once a day, after lunch Route of administration: Oral Storage Condition: Store in cool and dry place, away from sunlight, heat and moisture.

OTHER

Placebo (capsules containing Maltodextrin, Calcium carbonate, Sunset yellow, Maize starch, Mg Stearate, Talc)

Inclusion Criteria: 1. Age: 30 to 55 years (both inclusive) at the time of consent. 2. Sex: Adult male and female having wrinkles and fine lines at crow feet's area, facial hyperpigmentation and dark spots such as tan, pimple marks, sunspots, age spots, uneven skin tone on both side of face. 3. Females of childbearing potential should have a self-reported negative urine pregnancy test at the time of screening visit. 4. Subjects should not have used any cosmetic, nutraceutical or therapeutic products for skin ageing in last 1 month. 5. Subjects must be willing to stop using any cosmetics or any medical products for skin ageing for the duration of the study. 6. Subjects are not allowed to participate in any other study until this study is complete. 7. Subjects must be willing and able to follow the study directions and to return for all specified visits with the product. 8. Subjects must agree to record each use of the test products in the subject's diary card on daily basis. 9. Subjects must agree to record medication use during the study. Exclusion Criteria: 1. Subjects who are on steroids for last six months and using immunosuppressive, anti-inflammatory, or hormone-modulating medications that may interfere with study outcomes. 2. Subjects who have used any cosmetic, nutraceutical or therapeutic products for skin last one months. 3. Subjects currently using any oral supplement and topical products containing kojic acid, glycolic acid, niacinamide, alpha arbutin, vitamin C, retinoids, peptides, exfoliating acids, or any other skin-lightening, anti-ageing, or depigmenting agents within the past 4 weeks. 4. Subjects with a known history of hypersensitivity, allergic reactions, or intolerance (such as drowsiness, stomach discomfort, nausea, or vomiting). 5. Subjects with other dermatologic diseases whose presence or products could interfere with the assessment of study. 6. Subjects that are pregnant and/or breastfeeding. 7. The subject has a known allergy or sensitivity to product ingredients. 8. Subjects if do not agree to limit sun exposure to affected areas such as face during prolonged sun exposure. 9. The subject has any other skin conditions i.e. cuts, scratches, ring worms, etc. which in the opinion of the Investigator, will interfere with the study results or will create undue risk for the subject. 10. The subject has any of the conditions or factors that the Investigator believes may affect the response of the skin or the interpretation of the test results. 11. The subject is currently taking or has taken any medication, which the Investigator believes may influence the interpretation of the data. 12. Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion.