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The Effects of Terminalia Chebula Fruit Extract on the Gut Microbiome and Skin Biophysical Properties

NCT04597502 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2022-11-15

No results posted yet for this study

Summary

The purpose of this study is to assess the use of oral Terminalia chebula fruit extract on the gut microbiome and skin biophysical properties. The fruit is commonly used for skin treatments in India. It is thought to have antioxidant properties, reduce inflammation and affect the microorganisms in the gut.

The information the investigators will learn from this study may indicate how and if oral dosing can affect the skin and gut microbiome. This may lead to an improved understanding of the skin and determine whether these oral products are effective for improving the skin's appearance.

Conditions

  • Human Microbiome

Interventions

DIETARY_SUPPLEMENT

Terminalia Chebula fruit extract

Oral TC fruit extract supplement taken by mouth twice per day

DIETARY_SUPPLEMENT

Placebo

Oral placebo taken by mouth twice per day

OTHER

Topical Terminalia Chebula

Applied to both forearms and dorsal hands

OTHER

Topical Placebo

Applied to both forearms and dorsal hands

Sponsors & Collaborators

  • Sytheon Ltd.

    collaborator INDUSTRY

  • Integrative Skin Science and Research

    lead INDUSTRY

Principal Investigators

  • Raja K Sivamani, MD · Integrative Skin Science and Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-15
Primary Completion
2022-03-29
Completion
2022-09-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04597502 on ClinicalTrials.gov