NCT04597502已完成不适用
"The Effects of Synastol TC (Standardized Terminalia Chebula Fruit Extract) on the Gut Microbiome and Skin Biophysical Properties"
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Stool microbiome diversity
研究概览
简要总结
The purpose of this study is to assess the use of oral Terminalia chebula fruit extract on the gut microbiome and skin biophysical properties. The fruit is commonly used for skin treatments in India. It is thought to have antioxidant properties, reduce inflammation and affect the microorganisms in the gut.
The information the investigators will learn from this study may indicate how and if oral dosing can affect the skin and gut microbiome. This may lead to an improved understanding of the skin and determine whether these oral products are effective for improving the skin's appearance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-blinded placebo controlled
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females aged 25 to 55 years of age
- •Subject must be able to read and comprehend study procedures and consent forms.
排除标准
- •Subjects must have no history of malignancy, kidney disease, or chronic steroid use.
- •No history of smoking or chewing tobacco or vaping nicotine based products within the past year or if the pack-year history of smoking tobacco is greater than 5 pack-years.
- •No history of anorexia
- •Those that are currently taking serotonin or SSRIs.
- •No intake of pomegranate containing drinks, walnuts, and strawberries two weeks prior to enrollment and throughout the study
- •Those who are unable to discontinue topical medications for two weeks.
- •Individuals who have had any medical or cosmetic procedure, such as laser resurfacing, or plastic surgery to the test site (face) within the last 6 months. This includes botulinum toxin, dermal fillers, collagen or other similar cosmetic procedure
- •Individuals who are currently using or during the past 30 days have used hydroquinone, or a retinoid such as Retin A, or other Rx/OTC Retinoid, or steroids.
- •Those who are unable to discontinue systemic antibiotics or oral probiotics for one month prior starting the study.
- •Those who are unable to discontinue their Triphala or Terminalia chebula regimen for one month prior to starting study.
- •Subjects who are postmenopausal or perimenopausal as determined by the investigator based on history or documented menopause
- •Males will be excluded to reduce the contribution from gender-based differences in testosterone which can affect sebum production on the face.
- •Those who are pregnant or breastfeeding
- •Those that are prisoners or cognitively impaired
- •Those who have a known allergy to Triphala or Terminalia chebula
结局指标
主要结局
Stool microbiome diversity
时间窗: 8 weeks
Stool is collected and analyzed for species of bacteria through nucleic acid sequencing.
Sebum production
时间窗: 8 weeks
Delfin Sebumeter: 0-150 micrograms/cm\^2
次要结局
- Facial pigmentation(8 weeks)
- Facial redness - Device Based(8 weeks)
- hand and arm pigmentation(8 weeks)
- Ayurvedic typing questionnaire(8 weeks)
- Transepidermal water loss(8 weeks)
- Facial wrinkles(8 weeks)
- Salivary diurnal cortisol slope(8 weeks)
- Facial Redness - Image Based(8 weeks)
- hand and arm redness(8 weeks)
- Facial shine(8 weeks)
- Tolerability of Topical Products(8 weeks)
- Skin typing questionnaire(8 weeks)
- Skin Hydration(8 weeks)
研究者
研究点 (2)
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