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.

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: NovoBliss Research Pvt Ltd · Academic / Other
• Sex: All
• Age: 30 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

A total of 50 male and non-pregnant, non-lactating female subjects aged 30-55 years will be enrolled, with 25 subjects assigned to each product group (Test Product A and B). Approximately 40 subjects in total (20 per group) are expected to complete the study. Subjects will be randomized in a 1:1 ratio to receive either one of the two test treatments: 25 subjects in Test Product A and 25 subjects in Test Product B and 40 subjects will complete the study (20 subjects/treatment). The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects. Subjects will be contacted telephonically by recruiting department prior to the screening. There will be total of 5 visits during the study. The duration of the study will be 120 Days (16 weeks) from the enrolment. Subjects will be instructed to visit the facility as per below visits: * Visit 01 (Day 07 days prior to Day 01): Screening, ICD obtained, Medical history, Sleep Diary, Safety laboratory parameters * Visit: 02 (Day 01, Week 00): Enrolment, Baseline assessments. * Visit 03 (Day 45, Week 06): Product Phase, Evaluations * Visit 04 (Day 90, Week 12): Evaluations, Safety laboratory parameters and End of Product Phase * Visit 05 (Day 120, Week 16): Instrument Evaluations only and End of Study

Conditions

• Wrinkles
• Fine Lines
• Hyperpigmentation
• Dark Spots

Interventions

Type	Name	Description
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)	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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-05-01
• Completion: 2026-05-30
• First posted: 2026-01-07
• Last updated: 2026-01-07