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

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ClinicalTrials.gov Identifier: NCT03477825
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Raja Sivamani, MD, University of California, Davis

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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.
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 : March 12, 2018
Actual Primary Completion Date : August 16, 2018
Estimated Study Completion Date : January 24, 2020

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 Name: 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.




Primary Outcome Measures :
  1. Sebum excretion rate [ Time Frame: 4 weeks +/- 1 week ]
    Sebum production measured by sebumeter

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


Secondary Outcome Measures :
  1. Transepidermal water loss via Tewameter [ Time Frame: 4 weeks +/- 1 week ]
    Transepidermal water loss via Tewameter

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

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

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

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

  6. Digestion Questionnaire [ Time Frame: 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 [ Time Frame: 4 weeks +/- 1 week ]
    We will assess general health related symptoms based on level of frequency (Never, Sometimes, Often, Unsure).

  8. Food Intake Log [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03477825


Contacts
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Contact: Simran Dhaliwal, BS 916-734-6556 skdhali@ucdavis.edu
Contact: Iryna Rybak, BS 9116-734-1509 irybak@ucdavis.edu

Locations
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United States, California
University of California-Davis, Department of Dermatology Recruiting
Sacramento, California, United States, 95816
Contact: Simran Dhaliwal    916-734-6556    skdhali@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Raja Sivamani, MD UC Davis

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Responsible Party: Raja Sivamani, MD, Associate Professor of Clinical Dermatology, University of California, Davis
ClinicalTrials.gov Identifier: NCT03477825     History of Changes
Other Study ID Numbers: 1174110
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share individual patient data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Facies
Erythema
Disease Attributes
Pathologic Processes
Skin Diseases
Skin Manifestations
Signs and Symptoms