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

• Sponsor: University of California, Davis (Other)
• Overall Status: Completed
• CT.gov ID: NCT03477825
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 3
• Actual Duration (Months): 10.5
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sebum Production; Stool Microbiome; Transepidermal Water Loss; Facial Brrightness; Erythema; Wrinkles; Facial Shine	Dietary Supplement: Placebo Oral Tablet; Dietary Supplement: Rubia Cordifolia; Dietary Supplement: Triphala	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double blinded
• Primary Purpose: Other
• Official Title: Pilot Study on the Effects of Oral Triphala and Rubia Cordifolia on the Gut Microbiome and Skin Biophysical Properties
• Actual Study Start Date: Mar 12, 2018
• Actual Primary Completion Date: Aug 16, 2018
• Actual Study Completion Date: Jan 25, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Sebum excretion rate [4 weeks +/- 1 week]

   Sebum production measured by sebumeter

2. Stool microbiome diversity via stool sample [4 weeks +/- 1 week]

   Stool microbiome diversity via stool sample

Secondary Outcome Measures

1. Transepidermal water loss via Tewameter [4 weeks +/- 1 week]

   Transepidermal water loss via Tewameter

2. Facial brightness measured via photographic assessment [4 weeks +/- 1 week]

   Facial brightness measured via photographic assessment

3. Facial redness via photographic assessment [4 weeks +/- 1 week]

   Facial redness via photographic assessment

4. Facial wrinkles via photographic assessment [4 weeks +/- 1 week]

   Facial wrinkles via photographic assessment

5. Facial shine via photographic assessment [4 weeks +/- 1 week]

   Facial shine via photographic assessment

6. Digestion Questionnaire [4 weeks +/- 1 week]

   We will assess digestive symptoms such as stooling patterns and regularity based on level of frequency (Never, Sometimes, Always, Unsure).

7. Symptoms Questionnaire [4 weeks +/- 1 week]

   We will assess general health related symptoms based on level of frequency (Never, Sometimes, Often, Unsure).

8. Food Intake Log [4 weeks +/- 1 week]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California-Davis, Department of Dermatology	Sacramento	California	United States	95816

Sponsors and Collaborators

• University of California, Davis

Investigators

• Principal Investigator: Raja Sivamani, MD, UC Davis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT03477825
• Other Study ID Numbers: 1174110
• First Posted: Mar 26, 2018
• Last Update Posted: May 15, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Erythema; Facies

Study Results

No Results Posted as of May 15, 2019