Pilot Study of Triphala and Rubia Cordifolia on Gut Microbiome and Skin
NCT ID: NCT03477825
Last Updated: 2019-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2018-03-12
2019-01-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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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
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.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject must be able to read and comprehend study procedures and consent forms.
Exclusion Criteria
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.
18 Years
60 Years
ALL
Yes
Sponsors
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University of California, Davis
OTHER
Responsible Party
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Principal Investigators
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Raja Sivamani, MD
Role: PRINCIPAL_INVESTIGATOR
UC Davis
Locations
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University of California-Davis, Department of Dermatology
Sacramento, California, United States
Countries
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References
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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.
Other Identifiers
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1174110
Identifier Type: -
Identifier Source: org_study_id
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