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.

NCT07324759 | Not Yet Recruiting

• 1 other identifier: NB250038-PH_1.0_20Dec25
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Wrinkles; Fine Lines; Hyperpigmentation; Dark Spots

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Baseline on Day 01 and post usage of test products on Day 45 (±2 Days), Day 90 (±2 Days), Day 120 (±2 Days)

Secondary Outcomes (13)

• To evaluate the effectiveness of test products by assessing change in skin elasticity and firmness within and between product groups

  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

  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

  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.

  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

  Baseline on Day 01 and post usage of test products on Day 45 (±2 Days), Day 90 (±2 Days), Day 120 (±2 Days)

Other Outcomes (3)

• To evaluate the safety of the test product by clinical laboratory parameters

  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

  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

  From baseline to post-treatment on Day 45(±2 Days) and Day 90 (±2 Days)

Study Arms (2)

Standardized Saffron Extract (Crocus Sativus L) 10 mg Capsule

EXPERIMENTAL

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

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

PLACEBO COMPARATOR

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)

Interventions

Standardized Saffron Extract (Crocus Sativus L) 10 mg Capsule DIETARY_SUPPLEMENT

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.

Standardized Saffron Extract (Crocus Sativus L) 10 mg Capsule

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

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.

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

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Subjects must be willing to stop using any cosmetics or any medical products for skin ageing for the duration of the study.
• Subjects are not allowed to participate in any other study until this study is complete.
• Subjects must be willing and able to follow the study directions and to return for all specified visits with the product.
• Subjects must agree to record each use of the test products in the subject's diary card on daily basis.
• Subjects must agree to record medication use during the study.

You may not qualify if:

• 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).
• Subjects with other dermatologic diseases whose presence or products could interfere with the assessment of study.
• Subjects that are pregnant and/or breastfeeding.
• The subject has a known allergy or sensitivity to product ingredients.
• Subjects if do not agree to limit sun exposure to affected areas such as face during prolonged sun exposure.
• 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.
• 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.
• The subject is currently taking or has taken any medication, which the Investigator believes may influence the interpretation of the data.

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead
• Pharmanza Herbal Private Ltd: collaborator

MeSH Terms

Conditions

Hyperpigmentation

Interventions

Calcium Carbonate; 6-hydroxy-5-((p- sulfophenyl)azo)-2-naphthalenesulfonic acid disodium salt; Starch; Talc

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides; Magnesium Silicates; Magnesium Compounds; Silicates; Silicic Acid; Silicon Dioxide; Silicon Compounds

Study Officials

• Nayan Patel

  NovoBliss Research Pvt Ltd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maheshvari N Patel

CONTACT

09909013236; maheshvari@novobliss.in

Sheetal Khandwala

CONTACT

bd@novobliss.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 7, 2026
• Study Start: January 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-12