Pilot Study of Triphala and Rubia Cordifolia on Gut Microbiome and Skin

University of California (UC) Davis

Status: Completed

Conditions: Wrinkles; Sebum Production; Erythema; Facial Brrightness; Transepidermal Water Loss; Facial Shine; Stool Microbiome

Treatments: Dietary Supplement: Triphala; Dietary Supplement: Placebo Oral Tablet; Dietary Supplement: Rubia Cordifolia

Study type: Interventional

Funder types: Other

Identifiers

NCT03477825

1174110

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo Oral Tablet

Rubia Cordifolia

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Rubia Cordifolia

Triphala

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Triphala