A Clinical Study on the Improvement of Skin and Living Conditions After Drinking Rosa Roxburghii and Pomegranate Drinks

Botanee Group Co., Ltd.1 个研究点分布在 1 个国家目标入组 70 人开始时间: 2022年7月6日最近更新: 2024年2月23日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 70
试验地点: 1
主要终点: Changes in the proportion of crow's feet area

研究概览研究设计入排标准研究组 & 干预措施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

The main objective of the study is to observe changes in the subjects' skin condition and life status after 8 weeks of drinking rosa roxburghii and pomegranate drinks.

This is a single-center, randomized, single-blind, controlled, 8-week (56-day) clinical study conducted in Chinese healthy women aged 25-45 years old who were offered a rosa roxburghii and pomegranate drink.

详细描述

The study population is 70 healthy Chinese women aged 25-45 years who report current problems with dryness, roughness, dullness, and lack of elasticity on their face. The subjects will be randomly divided into an experimental group and a control product group of 35 subjects each.

Subjects will be formally enrolled after site assessment and subsequent site visits and test product administration. During the test cycle, subjects in the test group will take Prickly Pear Pomegranate Drink with active ingredients for 8 weeks, while the control product group will not take any test product. In order to avoid the influence of different skincare products on the results, all subjects will be asked to use a basic skincare product with moisturising ingredients only, provided by the sponsor, for the duration of the test. The efficacy of the test products will be verified by comparing the changes in skin condition and lifestyle of the subjects in the experimental group before taking the test products and 4 weeks and 8 weeks after taking the test products, as well as by comparing the differences in skin condition and lifestyle between the experimental group and the control group.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Other
盲法: Single (Outcomes Assessor)

入排标准

年龄范围: 25 Years 至 45 Years（Adult）
性别: Female
接受健康志愿者: 是

入选标准

•25-45 years old, Chinese female;
•The subject's self-reported facial problems such as dryness, roughness, dullness, and lack of elasticity;
•The subject's BMI is between 18~24kg/m2;
•After the doctor's clinical evaluation, there is at least one obvious pigmentation spot with an ITA° difference of more than 10° on the face and the surrounding adjacent skin, and the diameter is not less than 3mm (it cannot be freckles, pigmented nevi, etc. that are difficult to improve clinically using topical preparations);
•Corneometer base measurement of facial skin moisture at 15~45 (Corneometer Unit, C.U.) Between;
•Be in good health and free of any other chronic diseases other than skin problems or diseases being treated;
•Voluntarily participate in the test and sign the informed consent form;
•Willing to comply with all evaluation requirements;

排除标准

•Those who have used products, health foods or drugs with antioxidant and anti-aging effects in the past 2 months;
•Those who have used any products, health foods or drugs (such as hydroquinone preparations) that affect skin color in the past 2 months;
•Those who have used tretinoin preparations or undergone medical aesthetic treatments such as chemical peels, lasers, and pulsed light at the test site in the past 3 months;
•Those who are inevitably exposed to long-term sunlight;
•Intending to become pregnant, or being pregnant or breastfeeding;
•Have a history of alcoholism;
•Have a history of allergies;
•Participated in any clinical trial evaluation within 1 month;
•Those who have applied any anti-inflammatory drugs to the test site within the past two months;
•Those who have suffered from skin diseases (such as psoriasis, eczema, psoriasis, skin cancer, etc.);
•patients with insulin-dependent diabetes;
•Patients with asthma or other chronic respiratory diseases who are being treated;
•Have taken/injected anti-allergic drugs in the past 1 month;
•Patients who have received anti-cancer chemotherapy or immunotherapy patients within the past 6 months;
•Have a serious internal medicine disease, have any other health problems or chronic diseases;
•Coated with retinoids, A hydroxy acids, salicylic acids, hydroquinone within the past 3 months, or prescription drugs (antibiotics, retinoids, A hydroxy acids and steroids) in use within the past 6 months, oral contraceptives (if you have been taking the same contraceptive pills for the past 6 months, you can continue to take them);
•Experts or professionals believe that there are other iatrogenic causes that affect the results of the review.

研究组 & 干预措施

Blank Group

Other

Not taking drinks

干预措施: skin care product (Combination Product)

Drinks with active ingredients Rosa Roxburghii and Pomegranate

Experimental

Take drinks with active ingredients such as Rosa Roxburghii and Pomegranate. Drink every morning on an empty stomach, 20ml/2 sachets/day.

干预措施: skin care product (Combination Product)

Drinks with active ingredients Rosa Roxburghii and Pomegranate

Experimental

Take drinks with active ingredients such as Rosa Roxburghii and Pomegranate. Drink every morning on an empty stomach, 20ml/2 sachets/day.

干预措施: Drinks with active ingredients Rosa Roxburghii and Pomegranate (Other)