CTRI/2022/11/047149已完成未知
A Proof of Science/Concept clinical study with Randomized, Four Arm, Comparative, Single-Blind, Within the Arm - Dose Response Study to Evaluate Safety and Efficacy of Different Collagen Peptide Containing Test Treatments in Adult Human Subjects
Collagen Lifesciences Private Limited0 个研究点目标入组 264 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 264
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) Age: 30 to 50 years (both inclusive) at the time of consent.
- •2) Sex: Healthy non-pregnant/non-lactating females and Males.
- •3)Â Female of childbearing potential must have a reported negative pregnancy during screening and end of the study.
- •4)Â Subject is generally in good health.
- •5)Â Subject has mild to moderate crowsâ?? feet wrinkles.
- •6)Â Subject has mild to moderate joints pain, swelling, stiffness and decreased range of motion.
- •7)Â Subject has a score of at least â??mild skin agingâ?? based on PGA at screening visit.Â
- •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)Â Â Â Â Â Â Subject is able to forgo changes in baseline medications and nutritional supplements, any other collagen peptide powder during the study period.
- •14)Â Â Â Â Â Â 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)Â Â Â Â Â Â 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)Â Subject is willing to give written informed consent and are willing to follow the study procedure.
- •19)Â 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).
排除标准
- •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.
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