A Proof of Science Clinical Study With Randomized, Four Arm, Comparative, Single-Blind, Within the Arm - Dose-Response Study to Evaluate the Safety, Efficacy of Different Collagen Peptide Containing Test Treatments in Adult Human Subjects

NovoBliss Research Pvt Ltd1 个研究点分布在 1 个国家目标入组 264 人开始时间: 2023年1月11日最近更新: 2023年12月12日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 264
试验地点: 1
主要终点: Change in the facial wrinkles and fine lines of Crow's feet area, skin texture - roughness, dryness, wrinkles, smoothness

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A proof of science clinical study with randomized, four-arm, comparative, single-blind, within the arm - Dose-Response Study to evaluate the safety and efficacy of different collagen peptide-containing test treatments in adult human subjects.

The dose-response will be evaluated for the effectiveness of each test treatment in three different dosages that is 2.5 g Versus 5 g Versus 10 g.

22 subjects will be enrolled per dose per test treatment to complete 20 subjects per dose per test treatment.

详细描述

The dose response will be evaluated for the effectiveness of each test treatment in three different dosages that is 2.5 g Versus 5 g Versus 10 g.

22 subjects will be enrolled per dose per test treatment to complete 20 subjects per dose per test treatment.

There are four different test treatments as mentioned below will be tested during study.

Test Treatment A: VEGCOL™️ (Veg Collagen Peptide)
Test Treatment B: PROCOL (Bovine Collagen Peptide)
Test Treatment C: AQUACOL (Fish/Marine Collagen Peptide)
Test Treatment D: CALCOL (Chicken Collagen Peptide) Mode of Usage: 1 scoop/sachet of daily Route of Administration: Oral Administration with a glassful (approx. 250 mL) of water.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Supportive Care
盲法: Double (Investigator, Outcomes Assessor)

盲法说明

Subjects will be randomly assigned in as 1:1:1:1 ratio to receive either treatment A or B or C or D and three different dosages i.e. 2.5g, 5g, and 10g. The randomization code will be generated by NovoBliss Research. Single-blind will be followed for the evaluators.

Subjects will be randomly allocated to one of the treatment groups and one of treatment dose, as per the randomization code. This is single-blind study and blinding will be kept wherein neither the evaluator staff nor the Investigator shall be aware of the test treatment or test treatment dose allocation (except for osteoarthritis patients for Bovine Test Treatment). To maintain blinding, the study staff who involves in treatment dispensing and distribution will not be involved in any other study-related activities.

入排标准

年龄范围: 30 Years 至 50 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•The subject must fulfil all of the following inclusion criteria to be eligible for participation in the study unless otherwise specified.
•Age: 30 to 50 years (both inclusive) at the time of consent.
•Sex: Healthy non-pregnant/non-lactating females and Males.
•Female of childbearing potential must have a reported negative pregnancy during screening and end of the study.
•Subject is generally in good health.
•Subject has mild to moderate crows' feet wrinkles.
•Subject has mild to moderate joints pain, swelling, stiffness and decreased range of motion.
•Subject has a score of at least "mild skin aging" based on PGA at screening visit.
•Subject has Glogau Skin Age II or III as assessed by the Dermatologist/ Dermatologist Trained Evaluator.
•Subject having complaints of hair fall and decreased hair growth.
•The subject self-declare nonpathological thin, dry, and brittle hair and nails.
•Subject is willing to forgo cosmetic procedures 3 months prior to and for the duration of the study.
•Subject is able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.
•Subject is able to forgo changes in baseline medications and nutritional supplements, any other collagen peptide powder during the study period.
•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.
•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.
•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.
•Subject is willing not to introduce any new soaps, cleansers, lotions, creams, or any other face product etc. for the duration of the study.
•Subject is willing to give written informed consent and are willing to follow the study procedure.
•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.
•The subject is willing to use test treatment throughout the study period.
•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).

排除标准

•Subjects must not be enrolled in the study if they meet any one of the following criteria:
•Subject has a history of allergy or sensitivity to the test treatments ingredients.
•Subject who has a history of allergy with products containing Fish, Bovine, Chicken, broccoli and carrots.
•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.
•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.
•Subject has applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
•Subject is not willing to avoid unprotected sun or other UV radiation exposure during the study period.
•Subject has a history of prior use of hair growth treatment within 3 months.
•Subject has a history of any prior hair growth procedures (e.g., hair transplant or laser).
•Subject has a history of alcohol or drug addiction.
•Subject has plans of shaving scalp hair during the study.
•Subject is currently participating in or planning on starting a weight loss program that may result in a significant change in overall body weight.
•Subject has a history of prior use of skin radiance or wrinkle laser treatment within 3 months.
•Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion.
•Pregnant or breastfeeding or planning to become pregnant during the study period.
•Subject has a history of chronic illness which may influence the cutaneous state.
•Subjects participating in other similar nutraceuticals, food, supplemental or therapeutic trials or skin care products within the last four weeks

结局指标

主要结局

Change in the facial wrinkles and fine lines of Crow's feet area, skin texture - roughness, dryness, wrinkles, smoothness