To study the anti-ageing effect of test product in humans

A 6 group, parallel group, active and placebo controlled, double blinded, randomized study to evaluate the effects of an anti-ageing Nutraceutical product on hair, skin and nails in women and in use tolerance of products. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058600

Enrollment

180

Registered

2023-10-12

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: HCG30HG – Fish collagen peptide: The contents of 1 sachet will be emptied in 100 mL lukewarm water and mixed. To be taken once a day morning 30 minutes before breakfast. The product wil

Eligibility

Inclusion criteria

Inclusion criteria: 1. Voluntary women from 35 years to 55 years of age. 2. Volunteers with at least one blemish (UV, freckles, PIH, age related, liver spots etc.). 3. Volunteers with moderate wrinkles in crow’s feet area. 4. Having apparently healthy skin on test area. 5. Willingness to discontinue the use of other cosmetic products on face, hair which could impact the outcome of the study, during the course of the study. 6. Food habit- Non-vegetarians or consented vegetarians or occasional non vegetarian. 7. Subjects not on any nutritional supplement or not consuming any therapeutic medication for any disorder for last 45 days. 8. Subjects with no known allergies to foods & other substances 9. Accepting not to use products with the same end benefit during the entire study duration. 10. Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures. 11. Having signed a Consent Form, after being informed orally and in writing of all information concerning the study procedures and study objectives. 12. Willingness to avoid intense UV exposure as far as possible for the entire study duration.

Exclusion criteria

Exclusion criteria: 1. Pregnant women by UPT /lactating women. 2. Subjects showing abnormal levels in blood test parameters. (Subjects having abnormal values but are Clinically fit to participate in the trial would be enrolled in the study at Principal Investigator’s Discretion). 3. Any cutaneous conditions on test site (scars, moles, papules etc). 4. Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures. 5. Subjects with known allergies to ingredients of the product. 6. Subjects with substance abuse (alcohol, smoking and drugs ). 7. Subject likely to undergo any surgery in the period of the study. 8. Subjects who were on any other experimental Investigational study within last 1 month as identified during screening on visit 1. 9. Subjects having any hard damage to skin (e.g., excessive sunburn or suntan). 10. Subjects who have used a collagen peptide containing supplement in the past 6 months. 11. Subjects who have taken high doses of vitamin C ( >500 mg a day) or any other high dose antioxidant product in the past 1 month. 12. Individuals with chronic Gastrointestinal issues such as frequent indigestion, acidity, gas, bloating, GERD. 13. Subjects with severe acne and other major conditions.

Design outcomes

Primary

Measure	Time frame
To evaluate the effects of an anti-ageing Nutraceutical product on hair, skin and nails versus initial state, comparator product and placebo in women.Timepoint: Screening, Day 0, Day 30, Day 60	—

Secondary

Measure	Time frame
To evaluate the in-use tolerance of the product.Timepoint: Screening, Day 0, Day 30, Day 60	—

Countries

India

Contacts

Public ContactMs Preetha Paul

C.L.A.I.M.S. Pvt. Ltd.

preetha@claimsclinical.com66758851

Outcome results