CTRI/2023/07/055042尚未招募3 期
An Open Label, Prospective, Non-Randomised, Non-Comparative Single Arm Clinical Study the Effectiveness, Safety and Tolerability of â??FiCollaâ?? from Athos Collagen Private Limited as a Nutritional Supplement for Skin Health of Adults. - NI
Athos Collagen Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
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. Clinically Healthy adult subjects between the age of 30 and 55 years ( both ages and all genders inclusive) looking to improve their skin health.
- •2. Subject with fine lines and wrinkles.
- •3. Subject who are willing to abstain from the use of herbal , allopathic or other nutritional Supplements (intervention) that are indicated at improving skin health.
- •4. Subjects who are rated as Grade 2-4 on the Wrinkle Severity Scale.
- •5. Subject who are willing to give informed consent for participation , able to comprehend and understand the responsibilities during screening and treatment period.
- •6. Subjects who are willing not to participate in any other clinical trail during participation in the current trail.
排除标准
- •1. Subject with Known hypersensitivity to the ingredients of the investigational product
- •2. Subjects who are on Collagen supplements in any form.
- •3. Subjects who are vegetarians/vegans who object to consumption of animal origin investigational product
- •4. Subjects who are on tropical treatments /regimens (prescribed, clinical or self) of retinol, vitamin C, bakuchiol, peeling treatments of AHA, BHA, Glycolic Acid or any combination thereof aimed at improvement skin texture, hyperpigmentation, pore size.
- •5. Subjects who have an active dermatological procedure done up to 3 months prior to screening.
- •6. Subjects who have an active infection, disease or disorder that will prevent from fully satisfying the responsibilities of the study.
- •7. Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
- •8. Subjects on remission from cancer of any type less than 5 years at the time of screening.
- •9. Subjects who are planning a pregnancy and/or currently breastfeeding.
- •10. Subjects who have participated in a clinical study less than 1 month before screening.
- •11. Any significant medical condition (eg., significant psychiatric or neurological disorders, active alcohol,/drug abuse , etc), any medical condition that is unstable/poorly controlled or other factor ( e.g., planned relocation) that the investigator felt would interfere with study evaluations and study participation.
- •12. Subject who mentally unable to comphrened the responsibilities and adhere to the stipulations protocol.
- •13. Subjects, who in the opinion of the investigator are not eligible for enrolment in the study.
研究者
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