Pilot Study on the Effects of Oral Triphala and Rubia Cordifolia on the Gut Microbiome and Skin Biophysical Properties
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Sebum excretion rate
研究概览
简要总结
Few studies have assessed the effects of Triphala and Rubia Cordifolia from a skin biophysical perspective. Here, we aim to understand how these herbs can modulate the skin's barrier properties and the gut microbiome.
详细描述
Herbal supplements such as Rubia cordifolia and Triphala [a mix of Emblica officinalis (Amalaki), Terminalia bellerica (Bibhitaki), and Terminalia chebula (Haritaki)] are commonly used for skin based treatments in India. However, the scientific evidence for their specific effects on the skin are scant. Rubia cordifolia is a root that is used in skin care for pigmentation and inflammation.1 Triphala is thought to have antioxidant properties and reduce inflammation in general. Herbs have been shown to modulate the gut microbiome, as previous studies have suggested that triphala may modify the gut microbiome.2
However, few studies have assessed the effects of these herbs from a skin biophysical perspective. Here, we aim to understand how these herbs can modulate the skin's barrier properties and the gut microbiome.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blinded
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for subjects:
- •Age 18 to 60 years of age
- •Subject must be able to read and comprehend study procedures and consent forms.
排除标准
- •for subjects:
- •Subject should be generally healthy and have no smoking history in the past one year.
- •Subjects must have no history of diabetes, metabolic syndrome, known cardiovascular disease, malignancy, kidney disease, or chronic steroid use.
- •Those who are unable to discontinue topical medications for two weeks.
- •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 and Rubia Cordifolia regimen for one month prior to starting study.
- •Subjects who are postmenopausal
- •Those who are pregnant or breastfeeding
- •Those that are prisoners or cognitively impaired
- •Those who have a known allergy to Rubia cordifolia, Emblica officinalis, Terminalia bellerica, Terminalia chebula.
研究组 & 干预措施
Placebo
Group A: Placebo group (n = 10)
- Supplement appearing similar to Herbal formulations
- Each placebo tablet will contain microcrystalline cellulose, dicalcium phosphate, PVPK30, sodium starch glycolate, magnesium stearate, OpaDry orange coating.
- Dose: subjects in this group will take 4 placebo tablets per day
干预措施: Placebo Oral Tablet (Dietary Supplement)
Rubia Cordifolia
Group B: R. cordifolia group (n = 10)
- 2,000 mg R. cordifolia per day - supplied by Banyan Botanicals and following standard supplementation doses on commercially available supplement (https://www.banyanbotanicals.com/manjistha-tablets/)
- Each tablet contains 500 mg of R. cordifolia per tablet.
干预措施: Rubia Cordifolia (Dietary Supplement)
Triphala
Group C: Triphala group (n= 10)
- Tablets of Triphala will be supplied from Banyan Botanicals (https://www.banyanbotanicals.com/triphala-tablets-11/)
- Each tablet contains mix Emblica officinalis, Terminalia bellerica, and Terminalia chebula
- Dose: subjects will take 4 tablets per day, with a total dose of 2,000 mg of total herb.
干预措施: Triphala (Dietary Supplement)
结局指标
主要结局
Sebum excretion rate
时间窗: 4 weeks +/- 1 week
Sebum production measured by sebumeter
Stool microbiome diversity via stool sample
时间窗: 4 weeks +/- 1 week
Stool microbiome diversity via stool sample
次要结局
- Facial wrinkles via photographic assessment(4 weeks +/- 1 week)
- Facial shine via photographic assessment(4 weeks +/- 1 week)
- Transepidermal water loss via Tewameter(4 weeks +/- 1 week)
- Facial brightness measured via photographic assessment(4 weeks +/- 1 week)
- Digestion Questionnaire(4 weeks +/- 1 week)
- Facial redness via photographic assessment(4 weeks +/- 1 week)
- Symptoms Questionnaire(4 weeks +/- 1 week)
- Food Intake Log(4 weeks +/- 1 week)