An interventional study of Standardized Saffron Extract (Crocus Sativus L) 10 mg Capsule and Placebo (capsules containing Maltodextrin, Calcium carbonate, Sunset yellow, Maize starch, Mg Stearate, Talc) in Wrinkles, Fine Lines and Hyperpigmentation, sponsored by NovoBliss Research Pvt Ltd. Not yet recruiting. Open to participants aged 30 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by NovoBliss Research Pvt Ltd · Not applicable, Interventional, and Other
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.
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:
Exclusion Criteria:
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.
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.
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.
To evaluate the effectiveness of test products in terms of change in facial wrinkles and finelines of Crow's feet area, skin texture -dryness, roughness, smoothness, pores within and between product groups
By using Visioscan® VC 20 Plus
Time frame: Baseline on Day 01 and post usage of test products on Day 45 (±2 Days), Day 90 (±2 Days), Day 120 (±2 Days)
To evaluate the effectiveness of test products by assessing change in skin tone - L*, a*, b*, and ITA within and between product groups
By using Skin Colorimeter CL 400
Time frame: Baseline on Day 01 and post usage of test products on Day 45 (±2 Days), Day 90 (±2 Days), Day 120 (±2 Days)
To evaluate the effectiveness of test products by assessing change in skin elasticity and firmness within and between product groups
By using Cutometer Dual MPA 580 (R0 and R2)
Time frame: Baseline on Day 01 and post usage of test products on Day 45 (±2 Days), Day 90 (±2 Days), Day 120 (±2 Days)
To evaluate the effectiveness of test products by assessing change in skin texture such as skin dryness, redness, fine lines, coarse wrinkles, laxity, roughness and sallowness within and between product groups
By Physician Global Assessment (PGA) using Griffith's scale by Dermatologist or dermatologist trained evaluator
Time frame: from baseline on Day 01 and post usage of test products on Day 45 (±2 Days) and Day 90 (±2 Days)
To evaluate the effectiveness of test products by assessing change in wrinkles within and between product groups
Evaluated through Dermatological Evaluation using Glogau Scoring Scale
Time frame: from baseline on Day 01 and post usage of test products on Day 45 (±2 Days) and Day 90 (±2 Days)
4. To evaluate the effectiveness of test products by assessing change in skin pigmentation evaluated through Dermatological Evaluation using Skin Pigmentation Scoring within and between product groups.
By using Melasma Area and Severity Index Scale
Time frame: From baseline on Day 01 and post usage of test products on Day 45 (±2 Days) and Day 90 (±2 Days)
To evaluate the effectiveness of test products by assessing change in skin hydration within and between product groups
Using Corneometer® CM 825
Time frame: Baseline on Day 01 and post usage of test products on Day 45 (±2 Days), Day 90 (±2 Days), Day 120 (±2 Days)
To evaluate the effectiveness of test products by assessing change in skin thickness and density (Skin Ultrasound) within and between product groups.
Using Mindray DC 70 or similar
Time frame: Baseline on Day 01 and post usage of test products on Day 90 (±2 Days)
To evaluate the effectiveness of test products by assessing change in visual appearance of facial skin within and between product groups.
By using Visioface® RD
Time frame: baseline on Day 01 and post usage of test products on Day 45 (±2 Days), Day 90 (±2 Days), Day 120 (±2 Days)
To evaluate the effectiveness of test products by assessing change in Blood Biomarkers within and between product groups
Malondialdehyde, Total Antioxidant Capacity, Glutathione Levels, Procollagen Type-I C-Peptide, Filaggrin, Salivary Cortisol, Lysozyme Levels
Time frame: From baseline on Day 01 and post usage of test products on Day 90 (±2 Days)
To evaluate the effectiveness of test products by assessing change in sleep pattern by mood and sleep diary within and between product groups.
evaluated using Basic Nordic Sleep Questionnaire and PROMIS Sleep Disturbance and Distress Scale
Time frame: From baseline (Days -07) and Day 90 for Basic Nordic Sleep Questionnaire and PROMIS Sleep Disturbance and Distress Scale baseline (Day -07), Day 01 and post usage of test products on Day 45 (±2 Days), Day 90 (±2 Days), Day 120 (±2 Days)
To evaluate the effectiveness of test products by assessing change in hair thickness and density within and between product groups
Using CASLite Nova
Time frame: baseline on Day 01 and post usage of test products on Day 45 (±2 Days), Day 90 (±2 Days), Day 120 (±2 Days)
To evaluate the effectiveness of the test products by assessing change in stress level within and between product groups.
Using World Health Organization - Quality of Life Questionnaire-BREF
Time frame: From baseline on Day 01 and post usage of test products on Day 45 (±2 Days) and Day 90 (±2 Days)
To evaluate the effectiveness of test products by assessing change in general skin condition - lines/ wrinkles, age spots, elasticity/firmness, smoothness, radiance, tone within and between product groups.
Using Visual Analogue Scale (VAS) score
Time frame: From baseline on Day 01 and post usage of test products on Day 45 (±2 Days), Day 90 (±2 Days) and 120 (±2 Days)
To evaluate the effectiveness of test products by assessing changes in quality of life regarding test treatment's effect on daily life activities within and between product groups.
Using Dermatology Life Quality Index (DLQI)
Time frame: Baseline on Day 01 and post usage of test product on Day 45 (±2 Days), Day 90 (±2 Days), Day 120 (±2 Days)
To evaluate the safety of the test product by clinical laboratory parameters
complete blood count (CBC), Biochemistry, Urinalysis
Time frame: From baseline on 07 days prior to day 01 to post-product on Day 90 (±2 Days).
To evaluate the safety of the test product
By the monitoring of product emergent systematic evaluation of adverse events
Time frame: Post-product on Day 45(±2 Days) and Day 90 (±2 Days)
To evaluate the safety of the test treatment by checking compliance towards the test treatments and daily diary entries
For compliance-capsule counts
Time frame: From baseline to post-treatment on Day 45(±2 Days) and Day 90 (±2 Days)
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This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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NovoBliss Research Pvt Ltd