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

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

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.

Study Overview

• Status: Completed
• Conditions: Erythema; Wrinkles; Transepidermal Water Loss; Sebum Production; Stool Microbiome; Facial Brrightness; Facial Shine
• Intervention / Treatment: Dietary supplement: Placebo Oral Tablet; Dietary supplement: Rubia Cordifolia; Dietary supplement: Triphala

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • University of California-Davis, Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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	Dietary supplement: 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
Experimental: 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.	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.; Other Names: Manjistha
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sebum excretion rate	Sebum production measured by sebumeter	4 weeks +/- 1 week
Stool microbiome diversity via stool sample	Stool microbiome diversity via stool sample	4 weeks +/- 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transepidermal water loss via Tewameter	Transepidermal water loss via Tewameter	4 weeks +/- 1 week
Facial brightness measured via photographic assessment	Facial brightness measured via photographic assessment	4 weeks +/- 1 week
Facial redness via photographic assessment	Facial redness via photographic assessment	4 weeks +/- 1 week
Facial wrinkles via photographic assessment	Facial wrinkles via photographic assessment	4 weeks +/- 1 week
Facial shine via photographic assessment	Facial shine via photographic assessment	4 weeks +/- 1 week
Digestion Questionnaire	We will assess digestive symptoms such as stooling patterns and regularity based on level of frequency (Never, Sometimes, Always, Unsure).	4 weeks +/- 1 week
Symptoms Questionnaire	We will assess general health related symptoms based on level of frequency (Never, Sometimes, Often, Unsure).	4 weeks +/- 1 week
Food Intake Log	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.	4 weeks +/- 1 week

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Raja Sivamani, MD, UC Davis

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2018
• Primary Completion (Actual): August 16, 2018
• Study Completion (Actual): January 25, 2019

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): May 15, 2019
• Last Update Submitted That Met QC Criteria: May 13, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Disease Attributes; Skin Manifestations; Erythema; Facies
• Other Study ID Numbers: 1174110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We do not plan to share individual patient data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No