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

Wrinkles Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03477825
• Other study ID #: 1174110
• Status: Completed
• Phase: N/A
• Start date: March 12, 2018
• Est. completion date: January 25, 2019

Study information

• Verified date: May 2019
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 25, 2019
• Est. primary completion date: August 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of California-Davis, Department of Dermatology	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sebum excretion rate	Sebum production measured by sebumeter	4 weeks +/- 1 week
Primary	Stool microbiome diversity via stool sample	Stool microbiome diversity via stool sample	4 weeks +/- 1 week
Secondary	Transepidermal water loss via Tewameter	Transepidermal water loss via Tewameter	4 weeks +/- 1 week
Secondary	Facial brightness measured via photographic assessment	Facial brightness measured via photographic assessment	4 weeks +/- 1 week
Secondary	Facial redness via photographic assessment	Facial redness via photographic assessment	4 weeks +/- 1 week
Secondary	Facial wrinkles via photographic assessment	Facial wrinkles via photographic assessment	4 weeks +/- 1 week
Secondary	Facial shine via photographic assessment	Facial shine via photographic assessment	4 weeks +/- 1 week
Secondary	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
Secondary	Symptoms Questionnaire	We will assess general health related symptoms based on level of frequency (Never, Sometimes, Often, Unsure).	4 weeks +/- 1 week
Secondary	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