About this trial
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.
Eligibility criteria
Qualifiers
Age: 30 to 55 years (both inclusive) at the time of consent.
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.
Females of childbearing potential should have a self-reported negative urine pregnancy test at the time of screening visit.
Subjects should not have used any cosmetic, nutraceutical or therapeutic products for skin ageing in last 1 month.
Disqualifiers
Subjects who are on steroids for last six months and using immunosuppressive, anti-inflammatory, or hormone-modulating medications that may interfere with study outcomes.
Subjects who have used any cosmetic, nutraceutical or therapeutic products for skin last one months.
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.
Subjects with a known history of hypersensitivity, allergic reactions, or intolerance (such as drowsiness, stomach discomfort, nausea, or vomiting).
Trial design
Treatments tested in this trial
- Standardized Saffron Extract (Crocus Sativus L) 10 mg Capsule
- Placebo (capsules containing Maltodextrin, Calcium carbonate, Sunset yellow, Maize starch, Mg Stearate, Talc)
Treatment groups
Locations
Sponsors and collaborators
NovoBliss Research Pvt Ltd
Lead sponsor
Pharmanza Herbal Private Ltd
Collaborator