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

NCT ID: NCT06274450

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-06
• Study Completion Date: 2022-09-02

Brief Summary

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.

Detailed Description

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.

Conditions

Skin Laxity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Drinks with active ingredients Rosa Roxburghii and Pomegranate

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

Group Type: EXPERIMENTAL

skin care product

Intervention Type: COMBINATION_PRODUCT

Subjects are uniformly using skin care products provided by the sponsor during the test. Skin care product include: WINONA sensitiveness relieving moisturizing cleansing foam, WINONA sensitiveness relieving moisturizing lotion, WINONA anti-sensitive tolerance-extreme moisturizing cream

Drinks with active ingredients Rosa Roxburghii and Pomegranate

Intervention Type: OTHER

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

Blank Group

Not taking drinks

Group Type: OTHER

skin care product

Intervention Type: COMBINATION_PRODUCT

Subjects are uniformly using skin care products provided by the sponsor during the test. Skin care product include: WINONA sensitiveness relieving moisturizing cleansing foam, WINONA sensitiveness relieving moisturizing lotion, WINONA anti-sensitive tolerance-extreme moisturizing cream

Interventions

skin care product

Subjects are uniformly using skin care products provided by the sponsor during the test. Skin care product include: WINONA sensitiveness relieving moisturizing cleansing foam, WINONA sensitiveness relieving moisturizing lotion, WINONA anti-sensitive tolerance-extreme moisturizing cream

Intervention Type: COMBINATION_PRODUCT

Drinks with active ingredients Rosa Roxburghii and Pomegranate

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 25-45 years old, Chinese female;

2. The subject's self-reported facial problems such as dryness, roughness, dullness, and lack of elasticity;

3. The subject's BMI is between 18~24kg/m2;

4. 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);

5. Corneometer base measurement of facial skin moisture at 15~45 (Corneometer Unit, C.U.) Between;

6. Be in good health and free of any other chronic diseases other than skin problems or diseases being treated;

7. Voluntarily participate in the test and sign the informed consent form;

8. Willing to comply with all evaluation requirements;

Exclusion Criteria

1. Those who have used products, health foods or drugs with antioxidant and anti-aging effects in the past 2 months;

2. Those who have used any products, health foods or drugs (such as hydroquinone preparations) that affect skin color in the past 2 months;

3. 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;

4. Those who are inevitably exposed to long-term sunlight;

5. Intending to become pregnant, or being pregnant or breastfeeding;

6. Have a history of alcoholism;

7. Have a history of allergies;

8. Participated in any clinical trial evaluation within 1 month;

9. Those who have applied any anti-inflammatory drugs to the test site within the past two months;

10. Those who have suffered from skin diseases (such as psoriasis, eczema, psoriasis, skin cancer, etc.);

11. patients with insulin-dependent diabetes;

12. Patients with asthma or other chronic respiratory diseases who are being treated;

13. Have taken/injected anti-allergic drugs in the past 1 month;

14. Patients who have received anti-cancer chemotherapy or immunotherapy patients within the past 6 months;

15. Have a serious internal medicine disease, have any other health problems or chronic diseases;

16. 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);

17. Experts or professionals believe that there are other iatrogenic causes that affect the results of the review.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Botanee Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhan Wang, Master

Role: PRINCIPAL_INVESTIGATOR

Shenzhen Fubiyu Clinic

Locations

Shanghai China-norm Quality Technical Service Co ，Ltd

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

C2202112

Identifier Type: -

Identifier Source: org_study_id