Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 2:03 AM
Study NCT ID:
NCT07324759
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-07
First Post:
2025-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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.
Sponsor:
NovoBliss Research Pvt Ltd
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GLOW
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.
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: