Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT05613660
Eligibility Criteria:
Inclusion Criteria:
The subject must fulfil all of the following inclusion criteria to be eligible for participation in the study unless otherwise specified.
1. Age: 30 to 50 years (both inclusive) at the time of consent.
2. Sex: Healthy non-pregnant/non-lactating females and Males.
3. Female of childbearing potential must have a reported negative pregnancy during screening and end of the study.
4. Subject is generally in good health.
5. Subject has mild to moderate crows' feet wrinkles.
6. Subject has mild to moderate joints pain, swelling, stiffness and decreased range of motion.
7. Subject has a score of at least "mild skin aging" based on PGA at screening visit.
8. Subject has Glogau Skin Age II or III as assessed by the Dermatologist/ Dermatologist Trained Evaluator.
9. Subject having complaints of hair fall and decreased hair growth.
10. The subject self-declare nonpathological thin, dry, and brittle hair and nails.
11. Subject is willing to forgo cosmetic procedures 3 months prior to and for the duration of the study.
12. Subject is able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.
13. Subject is able to forgo changes in baseline medications and nutritional supplements, any other collagen peptide powder during the study period.
14. Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
15. If the female subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
16. If currently using hormonal contraception, has been using this form of contraception for at least 6 months and agrees to continue using the same contraception for the duration of the study.
17. Subject is willing not to introduce any new soaps, cleansers, lotions, creams, or any other face product etc. for the duration of the study.
18. Subject is willing to give written informed consent and are willing to follow the study procedure.
19. Subject is committed not to not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-thinning agents) or any other hair growth, treatment for thin hair, or hair products other than the test product for the entire duration of the study.
20. The subject is willing to use test treatment throughout the study period.
21. Only For Bovine Arm: Subjects with osteoarthritis patients having present complaints of pain and stiffness in joints (based on their current prescription and medical history).
Exclusion Criteria:
Subjects must not be enrolled in the study if they meet any one of the following criteria:
1. Subject has a history of allergy or sensitivity to the test treatments ingredients.
2. Subject who has a history of allergy with products containing Fish, Bovine, Chicken, broccoli and carrots.
3. Subject who has pre-existing or dormant dermatologic conditions (e.g., psoriasis rashes, eczema, seborrheic dermatitis, acne or any other) that could interfere with the outcome of the study as determined by the Investigator.
4. Subject has used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.
5. Subject has applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
6. Subject is not willing to avoid unprotected sun or other UV radiation exposure during the study period.
7. Subject has a history of prior use of hair growth treatment within 3 months.
8. Subject has a history of any prior hair growth procedures (e.g., hair transplant or laser).
9. Subject has a history of alcohol or drug addiction.
10. Subject has plans of shaving scalp hair during the study.
11. Subject is currently participating in or planning on starting a weight loss program that may result in a significant change in overall body weight.
12. Subject has a history of prior use of skin radiance or wrinkle laser treatment within 3 months.
13. Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion.
14. Pregnant or breastfeeding or planning to become pregnant during the study period.
15. Subject has a history of chronic illness which may influence the cutaneous state.
16. Subjects participating in other similar nutraceuticals, food, supplemental or therapeutic trials or skin care products within the last four weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
50 Years
Study:
NCT05613660
Study Brief:
Protocol Section:
NCT05613660