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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03477825
Other study ID # 1174110
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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