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WrinklesGLOWNCT07324759

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.

A study testing Standardized Saffron Extract (Crocus Sativus L) 10 mg Capsule in people with Wrinkles and Fine Lines, run by NovoBliss Research Pvt Ltd.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Wrinkles, Fine Lines, Hyperpigmentation
What is being tested?
Standardized Saffron Extract (Crocus Sativus L) 10 mg Capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
No sites listed yet
Study dates
1 Jan 2026to 30 May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Maheshvari N Patel contact

09909013236

maheshvari@novobliss.in

Sheetal Khandwala contact

bd@novobliss.in

About this study

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

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.

Read the 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
Being tested
Standardized Saffron Extract (Crocus Sativus L) 10 mg Capsule, Placebo (capsules containing Maltodextrin, Calcium carbonate, Sunset yellow, Maize starch, Mg Stearate, Talc)
Medical subject headings
Hyperpigmentation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standardized Saffron Extract (Crocus Sativus L) 10 mg CapsuleDietary 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.

  • 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.

Study groups in NCT07324759
Study groupRoleWhat they receive
Standardized Saffron Extract (Crocus Sativus L) 10 mg CapsuleExperimentalMode 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.
Receives: Dietary Supplement: Standardized Saffron Extract (Crocus Sativus L) 10 mg Capsule
Placebo ( Maltodextrin, Calcium carbonate, Sunset yellow, Maize starch, Mg Stearate, Talc)Placebo comparatorMode 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.
Receives: Other: Placebo (capsules containing Maltodextrin, Calcium carbonate, Sunset yellow, Maize starch, Mg Stearate, Talc)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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

    Measured: 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)
  1. 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)

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

  2. 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

    Measured: from baseline on Day 01 and post usage of test products on Day 45 (±2 Days) and Day 90 (±2 Days)

  3. 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

    Measured: from baseline on Day 01 and post usage of test products on Day 45 (±2 Days) and Day 90 (±2 Days)

  4. 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

    Measured: From baseline on Day 01 and post usage of test products on Day 45 (±2 Days) and Day 90 (±2 Days)

  5. To evaluate the effectiveness of test products by assessing change in skin hydration within and between product groups

    Using Corneometer® CM 825

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

  6. 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

    Measured: Baseline on Day 01 and post usage of test products on Day 90 (±2 Days)

  7. 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

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

  8. 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

    Measured: From baseline on Day 01 and post usage of test products on Day 90 (±2 Days)

  9. 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

    Measured: 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)

  10. To evaluate the effectiveness of test products by assessing change in hair thickness and density within and between product groups

    Using CASLite Nova

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

  11. 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

    Measured: From baseline on Day 01 and post usage of test products on Day 45 (±2 Days) and Day 90 (±2 Days)

  12. 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

    Measured: From baseline on Day 01 and post usage of test products on Day 45 (±2 Days), Day 90 (±2 Days) and 120 (±2 Days)

  13. 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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2026
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion1 May 2026 (estimated)
  4. Study completion30 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07324759
Sponsor's protocol ID
NB250038-PH_1.0_20Dec25
Acronym
GLOW
Status last verified
Dec 2025
First submitted
24 Dec 2025
Last updated
7 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Standardized Saffron Extract (Crocus Sativus L) 10 mg Capsule in people with Wrinkles and Fine Lines, run by NovoBliss Research Pvt Ltd.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maheshvari N Patel (09909013236, maheshvari@novobliss.in), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.

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