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

Not Applicable

Completed

• Conditions: Wrinkles; Sebum Production; Stool Microbiome; Facial Brrightness; Facial Shine; Erythema; Transepidermal Water Loss
• Interventions: Dietary Supplement: Placebo Oral Tablet; Dietary Supplement: Rubia Cordifolia; Dietary Supplement: Triphala

• Registration Number: NCT03477825
• Lead Sponsor: University of California, Davis

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-03-12
• Study First Submitted: 2018-03-13
• Study First Submitted QC: 2018-03-19
• Study First Posted: 2018-03-26
• Primary Completion: 2018-08-16
• Study Completion: 2019-01-25
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-13
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo 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
Rubia Cordifolia	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.
Triphala	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Transepidermal water loss via Tewameter	4 weeks +/- 1 week	Transepidermal water loss via Tewameter
Facial brightness measured via photographic assessment	4 weeks +/- 1 week	Facial brightness measured 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
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 redness via photographic assessment	4 weeks +/- 1 week	Facial redness via photographic assessment
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.

Trial Locations

Locations (1)

University of California-Davis, Department of Dermatology; 🇺🇸 Sacramento, California, United States