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

NCT03477825 | Completed

• 1 other identifier: 1174110
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Transepidermal water loss via Tewameter

  4 weeks +/- 1 week

• Facial brightness measured via photographic assessment

  4 weeks +/- 1 week

• Facial redness via photographic assessment

  4 weeks +/- 1 week

• Facial wrinkles via photographic assessment

  4 weeks +/- 1 week

• Facial shine via photographic assessment

  4 weeks +/- 1 week

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Rubia Cordifolia

EXPERIMENTAL

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

Triphala

EXPERIMENTAL

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

Interventions

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

Placebo

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.

Also known as: Manjistha

Rubia Cordifolia

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.

Triphala

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California-Davis, Department of Dermatology

Sacramento, California, 95816, United States

Location

Related Publications (1)

• 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.

  PMID: 32955913 DERIVED

MeSH Terms

Conditions

Erythema

Interventions

triphala

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Raja Sivamani, MD

  UC Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 26, 2018
• Study Start: March 12, 2018
• Primary Completion: August 16, 2018
• Study Completion: January 25, 2019
• Last Updated: May 15, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)