Clinical trial NCT03477825: Pilot Study of Triphala and Rubia Cordifolia on Gut Microbiome and Skin
Official title: Pilot Study on the Effects of Oral Triphala and Rubia Cordifolia on the Gut Microbiome and Skin Biophysical Properties
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sebum Production
Stool Microbiome
Transepidermal Water Loss
Facial Brrightness
Erythema
Wrinkles
Facial Shine
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sebum excretion rate
timeFrame: 4 weeks +/- 1 week
measure: Stool microbiome diversity via stool sample
timeFrame: 4 weeks +/- 1 week
Secondary outcomes:
measure: Transepidermal water loss via Tewameter
timeFrame: 4 weeks +/- 1 week
measure: Facial brightness measured via photographic assessment
timeFrame: 4 weeks +/- 1 week
measure: Facial redness via photographic assessment
timeFrame: 4 weeks +/- 1 week
measure: Facial wrinkles via photographic assessment
timeFrame: 4 weeks +/- 1 week
measure: Facial shine via photographic assessment
timeFrame: 4 weeks +/- 1 week
measure: Digestion Questionnaire
timeFrame: 4 weeks +/- 1 week
measure: Symptoms Questionnaire
timeFrame: 4 weeks +/- 1 week
measure: Food Intake Log
timeFrame: 4 weeks +/- 1 week
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California-Davis, Department of Dermatology
state: California
Study officials:
affiliation: UC Davis
name: Raja Sivamani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.