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Completed

NCT Number: NCT03477825

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California-Davis, Department of Dermatology

Sacramento, California, 95816, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for subjects:

  • Age 18 to 60 years of age
  • Subject must be able to read and comprehend study procedures and consent forms.

Exclusion criteria

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.

Treatment and study plan

Placebo Oral Tablet

Dietary Supplement

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

Dietary Supplement

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.

Other names: Manjistha

Triphala

Dietary Supplement

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 outcomes

  1. Sebum excretion rate

    Time frame: 4 weeks +/- 1 week

    Sebum production measured by sebumeter

  2. Stool microbiome diversity via stool sample

    Time frame: 4 weeks +/- 1 week

    Stool microbiome diversity via stool sample

Secondary outcomes

  1. Transepidermal water loss via Tewameter

    Time frame: 4 weeks +/- 1 week

    Transepidermal water loss via Tewameter

  2. Facial brightness measured via photographic assessment

    Time frame: 4 weeks +/- 1 week

    Facial brightness measured via photographic assessment

  3. Facial redness via photographic assessment

    Time frame: 4 weeks +/- 1 week

    Facial redness via photographic assessment

  4. Facial wrinkles via photographic assessment

    Time frame: 4 weeks +/- 1 week

    Facial wrinkles via photographic assessment

  5. Facial shine via photographic assessment

    Time frame: 4 weeks +/- 1 week

    Facial shine via photographic assessment

  6. Digestion Questionnaire

    Time frame: 4 weeks +/- 1 week

    We will assess digestive symptoms such as stooling patterns and regularity based on level of frequency (Never, Sometimes, Always, Unsure).

  7. Symptoms Questionnaire

    Time frame: 4 weeks +/- 1 week

    We will assess general health related symptoms based on level of frequency (Never, Sometimes, Often, Unsure).

  8. Food Intake Log

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Pilot Study on the Effects of Oral Triphala and Rubia Cordifolia on the Gut Microbiome and Skin Biophysical Properties

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Mar 26, 2018
Registry last updated
May 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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