Clinical Study Plan for CyanthOx™ Hard Capsule
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Hair and Scalp Condition (hair elasticity)
研究概览
简要总结
The goal of this clinical trial is to learn whether daily intake of CyanthOx™80 capsules can improve skin, scalp, hair, and selected blood biomarkers in healthy adults after 12 weeks.
Researchers will compare participants who take CyanthOx™80 with participants who take a placebo to evaluate its effectiveness and tolerability.
A total of 40 participants will be randomly assigned to the CyanthOx™80 group or placebo group, with 20 participants in each group. Participants will not know which capsule they receive.
Participants will:
Take one capsule daily for 12 weeks. Attend study visits at baseline and weeks 4, 8, and 12. Undergo non-invasive facial skin assessments at baseline, week 4, and week 12. Undergo scalp and hair assessments at baseline and weeks 4, 8, and 12. Provide a 10 mL blood sample at baseline and week 12 for tests related to antioxidant capacity, inflammation, aging, collagen, and blood lipids.
Complete questionnaires about skin condition and product satisfaction. Provide collected shed hair at weeks 4, 8, and 12. Have facial, scalp, and hair photographs taken. Identifiable areas will be masked before disclosure.
Before each skin or scalp assessment, participants will cleanse the test area with water and rest at room temperature for 30 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants aged over 18 years.
排除标准
- •Individuals who are unwilling to participate voluntarily.
- •Individuals diagnosed by a physician with skin disease, liver cirrhosis, or chronic renal failure.
- •Individuals with known allergies to cosmetics, drugs, or foods.
- •Pregnant or breastfeeding individuals.
- •Individuals taking medications for chronic diseases.
- •Students taught by the principal investigator.
- •Individuals unwilling to allow their study-related photographs to be disclosed. Vegetarians.
结局指标
主要结局
Change in Hair and Scalp Condition (hair elasticity)
时间窗: Baseline, Week 4, Week 8, and Week 12
Changes in hair elasticity measured using SHIMADZU EZ-SX Unit：percent change
Change in Blood Biomarkers (HA)
时间窗: Baseline and Week 12
Changes in biomarkers related to collagen metabolism measured using TEAC HA kits. Unit: percent change
Change in Hair and Scalp Condition (tensile strength)
时间窗: Baseline, Week 4, Week 8, and Week 12
Changes in tensile strength by using SHIMADZU EZ-SX Unit：percent change
Change in Blood Biomarkers (AGE)
时间窗: Baseline and Week 12
Changes in biomarkers related to aging measured using AGE ELISA kits. Unit: percent change
Product Tolerability
时间窗: Baseline to Week 12
Product tolerability will be assessed by recording any adverse events reported by participants during the study. The number and percentage of participants experiencing one or more adverse events will be summarized for each group. unit： number and percentage of participants
Participant-Reported Skin Condition and Product Satisfaction
时间窗: Baseline, Week 4, and Week 12
Perceived skin condition and product satisfaction will be assessed using a study-specific questionnaire with a 5-point scale, ranging from 1 to 5. Higher scores indicate greater perceived improvement or satisfaction. The percentage of participants with a score of 3 or higher will be reported. Unit：score
Change in Blood Biomarkers (TEAC)
时间窗: Baseline and Week 12
Changes in biomarkers related to antioxidant capacity using TEAC ELISA kits. Unit: percent change
Change in Hair and Scalp Condition (hair-root diameter)
时间窗: Baseline, Week 4, Week 8, and Week 12
Changes in hair-root diameter by using Mitutoyo, C/N293-100 Unit：percent change
Change in Hair and Scalp Condition (hair strength)
时间窗: Baseline, Week 4, Week 8, and Week 12
Changes in hair strength by using Hair Pull Test Unit：percent change
Change in Hair and Scalp Condition (hair shedding)
时间窗: Baseline, Week 4, Week 8, and Week 12
Changes in hair shedding by collecting and counting hairs found in the shower drain unit：percent change
Change in Blood Biomarkers (SOD)
时间窗: Baseline and Week 12
Changes in biomarkers related to antioxidant capacity measured using SOD ELISA kits. Unit: percent change
Change in Blood Biomarkers (GSH)
时间窗: Baseline and Week 12
Changes in biomarkers related to antioxidant capacity using GSH ELISA kits. Unit: percent change
Change in Blood Biomarkers (TNF-alpha)
时间窗: Baseline and Week 12
Changes in biomarkers related to inflammation measured using TNF-alpha ELISA kits. Unit: percent change
Change in Blood Biomarkers (Desmosine)
时间窗: Baseline and Week 12
Changes in biomarkers related to aging measured using Desmosine ELISA kits. Unit: percent change
Change in Blood Biomarkers (NAD/NADH)
时间窗: Baseline and Week 12
Changes in biomarkers related to antioxidant capacity measured using NAD/NADH ELISA kits. Unit: percent change
Change in Blood Biomarkers (Collagen)
时间窗: Baseline and Week 12
Changes in biomarkers related to collagen metabolism measured using Collagen ELISA kits. Unit: percent change
Change in Blood Biomarkers (Telomerase)
时间窗: Baseline and Week 12
Changes in biomarkers related to aging, measured using Telomerase ELISA kits. Unit: percent change
Change in Blood Biomarkers (CHOL)
时间窗: Baseline and Week 12
Changes in biomarkers related to blood lipid metabolism measured using automated clinical chemistry analyzer. Unit: percent change
Change in Blood Biomarkers (TG)
时间窗: Baseline and Week 12
Changes in biomarkers related to blood lipid metabolism measured using automated clinical chemistry analyzer. Unit: percent change
Change in Blood Biomarkers (HDL)
时间窗: Baseline and Week 12
Changes in biomarkers related to blood lipid metabolism measured using automated clinical chemistry analyzer. Unit: percent change
Change in Blood Biomarkers (LDL)
时间窗: Baseline and Week 12
Changes in biomarkers related to blood lipid metabolism measured using automated clinical chemistry analyzer. Unit: percent change
Facial Skin Analysis Parameters (skin spots)
时间窗: Baseline, Week 4, and Week 12
VISIA Micro-Analysis Skin Image Analyzer was utilized to measure skin spots. Units: percetage change.
Facial Skin Analysis Parameters (Wrinkle)
时间窗: Baseline, Week 4, and Week 12
VISIA Micro-Analysis Skin Image Analyzer was utilized to measure Wrinkle. Units: percetage change.
Facial Skin Analysis Parameters (Texture)
时间窗: Baseline, Week 4, and Week 12
VISIA Micro-Analysis Skin Image Analyzer was utilized to measure Texture. Units: percetage change.
Facial Skin Analysis Parameters (Spot)
时间窗: Baseline, Week 4, and Week 12
VISIA Micro-Analysis Skin Image Analyzer was utilized to measure Spot. Units: percetage change.
Facial Skin Analysis Parameters (UV Spot)
时间窗: Baseline, Week 4, and Week 12
VISIA Micro-Analysis Skin Image Analyzer was utilized to measure UV Spot. Units: percetage change.
Facial Skin Analysis Parameters (Brown Spot)
时间窗: Baseline, Week 4, and Week 12
VISIA Micro-Analysis Skin Image Analyzer was utilized to measure Brown Spot. Units: percetage change.
Facial Skin Analysis Parameters (Red Area)
时间窗: Baseline, Week 4, and Week 12
VISIA Micro-Analysis Skin Image Analyzer was utilized to measure Red Area. Units: percetage change.
Facial Skin Analysis Parameters (Collagen)
时间窗: Baseline, Week 4, and Week 12
DermaLab® Series SkinLab Combo was utilized to measure collagen. Units: percetage change.
Facial Skin Analysis Parameters (Brightness)
时间窗: Baseline, Week 4, and Week 12
Chroma Meter MM500 was utilized to measure Brightness. Units: percetage change.
Facial Skin Analysis Parameters (Erythema)
时间窗: Baseline, Week 4, and Week 12
Chroma Meter MM500 was utilized to measure Erythema. Units: percetage change.
Facial Skin Analysis Parameters (Melanin)
时间窗: Baseline, Week 4, and Week 12
Soft Plus was utilized to measure Melanin. Units: percetage change.
Facial Skin Analysis Parameters (Skin Hydration)
时间窗: Baseline, Week 4, and Week 12
Corneometer CM825 was utilized to measure Skin Hydration. Units: percetage change.
Facial Skin Analysis Parameters (Skin Elasticity)
时间窗: Baseline, Week 4, and Week 12
Soft Plus was utilized to measure Skin Elasticity. Units: percetage change.
Facial Skin Analysis Parameters (Transepidermal Water Loss)
时间窗: Baseline, Week 4, and Week 12
Tewameter TM300 was utilized to measure Transepidermal Water Loss. Units: percetage change.
次要结局
未报告次要终点