Erythema, Facial Brrightness, Facial Shine, Sebum Production, Stool Microbiome, Transepidermal Water Loss, Wrinkles
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTPlacebo Oral Tablet
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
DIETARY_SUPPLEMENTRubia 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.
DIETARY_SUPPLEMENTTriphala
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.
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blinded
Intervention model description
Thirty (30) subjects meeting the inclusion criteria without any of the exclusion criteria will be enrolled in this study. This study will be a double blinded study. Each subject will be randomized a priori to receive either placebo, Rubia cordifolia, or Triphala tablets.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
for subjects: 1. Age 18 to 60 years of age 2. Subject must be able to read and comprehend study procedures and consent forms.
Exclusion criteria
for subjects: 1. Subject should be generally healthy and have no smoking history in the past one year. 2. Subjects must have no history of diabetes, metabolic syndrome, known cardiovascular disease, malignancy, kidney disease, or chronic steroid use. 3. Those who are unable to discontinue topical medications for two weeks. 4. Those who are unable to discontinue systemic antibiotics or oral probiotics for one month prior starting the study. 5. Those who are unable to discontinue their Triphala and Rubia Cordifolia regimen for one month prior to starting study. 6. Subjects who are postmenopausal 7. Those who are pregnant or breastfeeding 8. Those that are prisoners or cognitively impaired 9. Those who have a known allergy to Rubia cordifolia, Emblica officinalis, Terminalia bellerica, Terminalia chebula.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sebum excretion rate | 4 weeks +/- 1 week | Sebum production measured by sebumeter |
| Stool microbiome diversity via stool sample | 4 weeks +/- 1 week | Stool microbiome diversity via stool sample |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Facial redness via photographic assessment | 4 weeks +/- 1 week | Facial redness via photographic assessment |
| Facial wrinkles via photographic assessment | 4 weeks +/- 1 week | Facial wrinkles via photographic assessment |
| Facial shine via photographic assessment | 4 weeks +/- 1 week | Facial shine via photographic assessment |
| Transepidermal water loss via Tewameter | 4 weeks +/- 1 week | Transepidermal water loss via Tewameter |
| Symptoms Questionnaire | 4 weeks +/- 1 week | We will assess general health related symptoms based on level of frequency (Never, Sometimes, Often, Unsure). |
| Food Intake Log | 4 weeks +/- 1 week | We ask for a food diary that will account for all food and drink intake in a given day for three days prior to their next visit. The diary will note what food/beverage and how much of that item was consumed. |
| Digestion Questionnaire | 4 weeks +/- 1 week | We will assess digestive symptoms such as stooling patterns and regularity based on level of frequency (Never, Sometimes, Always, Unsure). |
| Facial brightness measured via photographic assessment | 4 weeks +/- 1 week | Facial brightness measured via photographic assessment |
Countries
United States
Outcome results
None listed