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

NCT ID: NCT03477825

Last Updated: 2019-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-12

Study Completion Date

2019-01-25

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double blinded

Study Groups

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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

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type 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

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.

Group Type EXPERIMENTAL

Rubia Cordifolia

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Triphala

Intervention Type 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.

Interventions

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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

Intervention Type 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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Manjistha

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raja Sivamani, MD

Role: PRINCIPAL_INVESTIGATOR

UC Davis

Locations

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University of California-Davis, Department of Dermatology

Sacramento, California, United States

Site Status

Countries

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United States

References

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Peterson CT, Pourang A, Dhaliwal S, Kohn JN, Uchitel S, Singh H, Mills PJ, Peterson SN, Sivamani RK. Modulatory Effects of Triphala and Manjistha Dietary Supplementation on Human Gut Microbiota: A Double-Blind, Randomized, Placebo-Controlled Pilot Study. J Altern Complement Med. 2020 Nov;26(11):1015-1024. doi: 10.1089/acm.2020.0148. Epub 2020 Sep 18.

Reference Type DERIVED
PMID: 32955913 (View on PubMed)

Other Identifiers

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1174110

Identifier Type: -

Identifier Source: org_study_id

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