None listed
Conditions
Interventions
Intervention1: VC-KON (Vegan Collagen Supplement): One Sachet once a day orally, swallowed with 200 ml of water for 60 days.
Control Intervention1: N/A: N/A
Sponsors
Konark Herbal & HealthCare Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy adult males and non-pregnant, non-lactating females aged 30 50 years at the time of screening. 2.Participants in good general health, as determined by medical history and investigator assessment. 3.Presence of mild to moderate crow s feet wrinkles, as assessed by the investigator. 4.Presence of mild to moderate joint pain, swelling, stiffness, and reduced range of motion, including individuals with osteoarthritis, based on medical history and current prescription records. 5.A Physician s Global Assessment (PGA) score indicating at least mild skin aging. 6.Glogau photoaging classification of Grade II or III at screening. 7.Self-reported hair fall and reduced hair growth, with non-pathological thin, dry, or brittle hair. 8.Self-reported weak, dry, or brittle nails. 9.No cosmetic or aesthetic procedures involving the face, skin, hair, or nails for at least 3 months prior to screening and throughout the study duration. 10.Willingness to avoid initiation of any new skincare, haircare, or cosmetic products during the study period. 11.Willingness to maintain stable baseline medications and nutritional supplements, with no use of any collagen or collagen-peptide supplements during the study. 12.Participants using hormonal contraceptives or hormone replacement therapy must have been on a stable dose for at least 6 weeks prior to screening and agree to continue the same regimen throughout the study. 13.Female participants of childbearing potential must agree to use a reliable method of contraception during the study period. 14.Willingness to refrain from using medicated or prescription shampoos, hair products containing minoxidil or anti-thinning agents, or any other hair growth treatments during the study. 15.Ability and willingness to comply with all study procedures and visit schedules. 16.Provision of written informed consent prior to initiation of any study-related procedures.
Exclusion criteria
Exclusion criteria: 1.History of allergy, hypersensitivity, or intolerance to any ingredient of the investigational product or placebo. 2.Presence of active or dormant dermatological conditions (e.g., psoriasis, eczema, seborrheic dermatitis, acne, or other skin disorders) that may interfere with study assessments, as determined by the investigator. 3.Participant with vitamin D deficiency 4.Use of systemic antibiotics, retinoids, or oral corticosteroids within 4 weeks prior to screening, or anticipated requirement during the study period. 5.Use of topical or systemic treatments affecting skin, hair, or nail outcomes within 4 weeks prior to screening. 6.History of cosmetic, laser, energy-based, or invasive dermatological procedures involving skin or face within 3 months prior to screening. 7.History of hair growth treatments or procedures (e.g., hair transplant, laser therapy) within 3 months prior to screening, or planned scalp hair shaving during the study. 8.Unwillingness to avoid excessive sun exposure or ultraviolet radiation during the study period. 9.Participation in another clinical, cosmetic, nutraceutical, or therapeutic study within 4 weeks prior to screening. 10.Pregnant or breastfeeding women, or women planning pregnancy during the study period. 11.History of alcohol or substance abuse, as judged by the investigator. 12.Participation in or intention to start a weight-loss program or major dietary modification likely to significantly affect body weight during the study. 13.Presence of clinically significant acute or chronic illness that may affect skin, hair, nail, joint, or muscle outcomes, or participants safety. 14.Any condition which, in the opinion of the investigator or dermatologist, may compromise participant safety, protocol compliance, or interpretation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Glogau Photoaging Classification grade at Day 60, as assessed by the dermatologist. Change from baseline in skin elasticity (R2 parameter) measured using Cutometer at 60 days. Change from baseline to Day 60 in scalp hair parameters, including hair density (hairs/cm ) and mean hair shaft thickness ( m), assessed using a validated digital phototrichogram system within a predefined 1 cm tattoo-marked scalp area. Change from baseline in joint pain score measured using a 10-cm Visual Analog Scale (VAS) at 60 days. Change from baseline in handgrip muscle strength (kg) at Week 60 dayTimepoint: Change from baseline in Glogau Photoaging Classification grade at Day 60, as assessed by the dermatologist. Change from baseline in skin elasticity (R2 parameter) measured using Cutometer at 60 days. Change from baseline to Day 60 in scalp hair parameters, including hair density (hairs/cm ) and mean hair shaft thickness ( m), assessed using a validated digital phototrichogram system within a predefined 1 cm tattoo-marked scalp area. Change from baseline in joint pain score measured using a 10-cm Visual Analog Scale (VAS) at 60 days. Change from baseline in handgrip muscle strength (kg) at Week 60 day | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess active hair shedding by quantifying the number of hairs shed during standardized combing for 60 seconds Mean change from baseline to Day 60 in the LSEQ Quality of Sleep (QOS) domain score, reflecting improvement in deep and sound sleep. Mean change from baseline to Day 60 in individual and total PGA dermatological scores assessed using the Modified Griffiths Scale. Change from baseline to Day 60 in nail condition as assessed by Physician Global Assessment (PGA) score.Timepoint: Mean Change from Baseline to day 60. | — |
Countries
India
Contacts
Public ContactDr Ravindra Mote
Mediclin Clinical Research
Outcome results
None listed