CTRI/2022/11/047537已完成未知
A Prospective, Double-Blind, Randomized, Parallel, Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of Ashwagandha Lotion in Photo-Aged Healthy Subjects.
Ixoreal Biomed0 个研究点目标入组 56 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
- 56
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.Healthy adult men and women participants more than equal to 18 years and less than equal to 60 years of age.
- •2.Participants who agree not to use any medication (prescription and over the counter), including vitamins and minerals, during or before the course of this study.
- •3.Participants willing to undergo preparation for Facial Skin Assessment.
- •4.Willingness to follow the protocol requirements as evidenced by written informed consent.
- •5.Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination.
- •6.Participants or LAR are able to and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements.
- •7.Participants with Fitzpatrick photo-type III-VI skin.
- •8.Participants who agree to take investigational product (i.e., Till Day 60 ± 4).
排除标准
- •1.Participants having any clinically significant medical history, medical finding including rosacea, eczema, psoriasis, and atopic dermatitis or an on-going medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol.
- •2.Participants having a history of hypersensitivity reactions (i.e., allergic or oversensitivity to usual doses).
- •3.Participants who have participated in a clinical study during the preceding 180 days.
- •4.Participants with a medical history of using a medicated acne treatment within the last 6 months.
- •5.Participants with active skin disease in the test area.
- •6.Participants with a medical history of dysplastic nevi or melanoma on the face.
- •7.Participants with moles, cysts, tattoos, scars, irritated skin, hairs, etc. at the test area that could influence the investigation.
- •8.Participants on systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines within 7 days prior to the start of the study and/or throughout the entire course of the study.
- •9.Participants on systemic use of anti-microbials within the last month.
- •10.Participants with a medical history of abnormal response to sunlight.
- •11.Participants with a history of mental illness.
- •12.Participants who are medically diagnosed acne vulgaris, acne conglobate, fulminans, secondary acne (drug induced acne) or any acne requiring systemic or topical treatment.
- •13.Participants who had an aesthetic, cosmetic or dermatological treatment in the treatment area (face) within the last month.
- •14.Participants who had intense sun exposure, Ultraviolet (UV)- treatments or tanning salon visit within the last 2 weeks.
- •15.Participants with a known or suspected intolerance, allergy or hypersensitivity to study materials (or closely related compounds) or any of their stated ingredients.
- •16.Participants with a history of allergies to cosmetic products or medicated acne treatments.
- •17.Participants with any other condition which the principal investigator thinks may jeopardize the safety of subjects—patients with uncontrolled, unstable comorbidities.
- •18.Participants working outdoors.
研究者
相似试验
已完成
不适用
Study to Evaluate the effect and Safety of Ashwagandha Serum on the hair health in healthy adult humans.CTRI/2022/11/047539Ixoreal Biomed68
进行中（未招募）
不适用
Efficacy and Safety of Ashwagandha topical lotion application on the Skin Health in Healthy AdultsCTRI/2022/09/045512Ixoreal Biomed Private Limited
已完成
不适用
Efficacy and Safety of Ashwagandha Serum Application on the Hair Health in Healthy AdultsCTRI/2022/09/045469Ixoreal Biomed Private Limited41
招募中
4 期
To Evaluate Efficacy of Lutemax 2020 (Lutein 10 mg & Zeaxanthin Isomers 2 mg) on Vision and Cognitive Performance in Healthy Children.CTRI/2022/05/042364OmniActive Health Technologies Ltd
已完成
3 期
To understand the safety and effects of Ashwagandha in healthy adults with stressCTRI/2024/03/063786OmniActive Health Technologies Limited90