search
Back to results

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

Primary Purpose

Sebum Production, Stool Microbiome, Transepidermal Water Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo Oral Tablet
Rubia Cordifolia
Triphala
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sebum Production

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of California-Davis, Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Rubia Cordifolia

Triphala

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

Sebum excretion rate
Sebum production measured by sebumeter
Stool microbiome diversity via stool sample
Stool microbiome diversity via stool sample

Secondary Outcome Measures

Transepidermal water loss via Tewameter
Transepidermal water loss via Tewameter
Facial brightness measured via photographic assessment
Facial brightness measured via photographic assessment
Facial redness via photographic assessment
Facial redness via photographic assessment
Facial wrinkles via photographic assessment
Facial wrinkles via photographic assessment
Facial shine via photographic assessment
Facial shine via photographic assessment
Digestion Questionnaire
We will assess digestive symptoms such as stooling patterns and regularity based on level of frequency (Never, Sometimes, Always, Unsure).
Symptoms Questionnaire
We will assess general health related symptoms based on level of frequency (Never, Sometimes, Often, Unsure).
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.

Full Information

First Posted
March 13, 2018
Last Updated
May 13, 2019
Sponsor
University of California, Davis
search

1. Study Identification

Unique Protocol Identification Number
NCT03477825
Brief Title
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 12, 2018 (Actual)
Primary Completion Date
August 16, 2018 (Actual)
Study Completion Date
January 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sebum Production, Stool Microbiome, Transepidermal Water Loss, Facial Brrightness, Erythema, Wrinkles, Facial Shine

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blinded
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Rubia Cordifolia
Arm Type
Experimental
Arm Description
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.
Arm Title
Triphala
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Rubia Cordifolia
Other Intervention Name(s)
Manjistha
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Triphala
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sebum excretion rate
Description
Sebum production measured by sebumeter
Time Frame
4 weeks +/- 1 week
Title
Stool microbiome diversity via stool sample
Description
Stool microbiome diversity via stool sample
Time Frame
4 weeks +/- 1 week
Secondary Outcome Measure Information:
Title
Transepidermal water loss via Tewameter
Description
Transepidermal water loss via Tewameter
Time Frame
4 weeks +/- 1 week
Title
Facial brightness measured via photographic assessment
Description
Facial brightness measured via photographic assessment
Time Frame
4 weeks +/- 1 week
Title
Facial redness via photographic assessment
Description
Facial redness via photographic assessment
Time Frame
4 weeks +/- 1 week
Title
Facial wrinkles via photographic assessment
Description
Facial wrinkles via photographic assessment
Time Frame
4 weeks +/- 1 week
Title
Facial shine via photographic assessment
Description
Facial shine via photographic assessment
Time Frame
4 weeks +/- 1 week
Title
Digestion Questionnaire
Description
We will assess digestive symptoms such as stooling patterns and regularity based on level of frequency (Never, Sometimes, Always, Unsure).
Time Frame
4 weeks +/- 1 week
Title
Symptoms Questionnaire
Description
We will assess general health related symptoms based on level of frequency (Never, Sometimes, Often, Unsure).
Time Frame
4 weeks +/- 1 week
Title
Food Intake Log
Description
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.
Time Frame
4 weeks +/- 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for subjects: Age 18 to 60 years of age Subject must be able to read and comprehend study procedures and consent forms. Exclusion Criteria for subjects: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raja Sivamani, MD
Organizational Affiliation
UC Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California-Davis, Department of Dermatology
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan to share individual patient data.
Citations:
PubMed Identifier
32955913
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs