Health Condition 1: L709- Acne, unspecified Health Condition 2: M170- Bilateral primary osteoarthritis of knee Health Condition 3: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere Health Condition 4: M256- Stiffness of joint, not elsewhereclassified
Conditions
Interventions
Intervention1: VEGCOL�� (Veg Collagen Peptide): 1 scoop/sachet of daily, Oral Administration with a glassful (approx. 250 mL) of water for consecutive 60 Days
Intervention2: PROCOL (Bovine Collag
Sponsors
Collagen Lifesciences Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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 crowsâ?? 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 â??mild skin agingâ?? 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
Exclusion 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)Â 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)Â 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)Â 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 dermatologistâ??s/investigatorâ??s discretion. 14)Â Pregnant or breastfeeding or planning to become pregnant during the study period. 15)Â Subject has a history of chronic illness which may influence the cutaneous state. 16)Â Subjects participating in other similar nutraceuticals, food, Â supplemental or therapeutic trials or skin care products within the last four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of the test treatments for following parameters: a)Â Â Change in the facial wrinkles and fine lines of Crowâ??s feet area, skin texture â?? roughness, dryness, wrinkles, smoothness b)Â Â Change in skin elasticity c)Â Â Change in skin hydration d)Â Â Change in Hair Thickness and Density u e)Â Â Change in Hair Fall f)Â Â Â Change in weight and BMI g)Â Â Change in Joints Pain using VAS (0-10 cm) scoring evaluated by trained study staff h)Â Â Change in muscle strength - as assessed by the sum of handgrip, elbow flexion and extension and knee flexion and extension strengthTimepoint: Baseline (Day01) to Day 10, Day 30 and Day 60, between treatments, between three different dosages and within the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from before (Day01) and after (Day60) facial photographs (left-center-right) and nails photographs of the subjects in three different dosages and between treatmentsTimepoint: Before (Day01) and after (Day60);To assess the effect of test treatment in terms of change in hair growth on the scalpTimepoint: Baseline visit during Visit 01(04 days before Day 01) and Visit 02 (Day01) before usage to Visit 05 (Day 57) and Visit 06 (Day 60) after treatment, between treatments, between three different dosages and within the treatment;To evaluate the effectiveness of the test treatments after 8 weeks of treatment in Anagen Telogen (A-T) ratio using Pluck TestTimepoint: Baseline (Day01) to Day 60, between treatments, between three different dosages and within the treatment;To evaluate the effectiveness of the test treatments for following parameters: a.    Change in PGA scoring using Griffiths scale - Skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallowness. b.    Change in Glogau Skin Age. c.    Change on hair strength by Pull test . d.    Change in PGA score for assessment of the signs of brittle nails, surface roughness, raggedness and peeling. e.    Change in Sleep Quality using Leeds Sleep Evaluation Questionnaires (LSEQ). f.     Consumption of Rescue Medications for Joints pain evaluated. g.    About test treatment perception and consumer feedback on Skin elasticity, suppleness, deep and sound sleep, digestion and gut health, joint health, nail and hair health using hedonic questionnaires.Timepoint: Baseline (Day01) to Day 10, Day 30 and Day 60, between treatments, between three different dosages and within the treatment;To evaluate the effectiveness of the test treatments in change in PGA score for assessment of Acne Severity.Timepoint: Baseline (Day01) to Day 10, Day 30 and Day 60, between treatments, between three different dosages and within the treatment in enrolled subjec | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed