Human MicrobiomeNCT04597502
The Effects of Terminalia Chebula Fruit Extract on the Gut Microbiome and Skin Biophysical Properties
A study testing Terminalia Chebula fruit extract and Topical Terminalia Chebula in people with Human Microbiome, run by Integrative Skin Science and Research at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Microbiome
- What is being tested?
- Terminalia Chebula fruit extract and Topical Terminalia Chebula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2020to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females aged 25 to 55 years of age
- Subject must be able to read and comprehend study procedures and consent forms.
- BMI 25-35
Who cannot join
- Subjects must have no history of malignancy, kidney disease, or chronic steroid use.
- No history of smoking or chewing tobacco or vaping nicotine based products within the past year or if the pack-year history of smoking tobacco is greater than 5 pack-years.
- No history of anorexia
- Those that are currently taking serotonin or SSRIs.
- No intake of pomegranate containing drinks, walnuts, and strawberries two weeks prior to enrollment and throughout the study
- Those who are unable to discontinue topical medications for two weeks.
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- Individuals who have had any medical or cosmetic procedure, such as laser resurfacing, or plastic surgery to the test site (face) within the last 6 months. This includes botulinum toxin, dermal fillers, collagen or other similar cosmetic procedure
- Individuals who are currently using or during the past 30 days have used hydroquinone, or a retinoid such as Retin A, or other Rx/OTC Retinoid, or steroids.
- 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 or Terminalia chebula regimen for one month prior to starting study.
- Subjects who are postmenopausal or perimenopausal as determined by the investigator based on history or documented menopause
- Males will be excluded to reduce the contribution from gender-based differences in testosterone which can affect sebum production on the face.
- Those who are pregnant or breastfeeding
- Those that are prisoners or cognitively impaired
- Those who have a known allergy to Triphala or Terminalia chebula
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Skin Science and Research
Sacramento, California, 95815
About this study
Official title: "The Effects of Synastol TC (Standardized Terminalia Chebula Fruit Extract) on the Gut Microbiome and Skin Biophysical Properties"
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
- Being tested
- Terminalia Chebula fruit extract, Placebo, Topical Terminalia Chebula, Topical Placebo
- Keywords
- gut microbiome, skin, dermatology, terminalia chebula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terminalia Chebula fruit extractDietary supplement
Oral TC fruit extract supplement taken by mouth twice per day
PlaceboDietary supplement
Oral placebo taken by mouth twice per day
Topical Terminalia ChebulaOther
Applied to both forearms and dorsal hands
Topical PlaceboOther
Applied to both forearms and dorsal hands
| Study group | Role | What they receive |
|---|---|---|
| Oral Placebo, Topical Placebo | Placebo comparator | Oral Placebo, Topical Placebo on both forearms and dorsal hands Receives: Dietary Supplement: Placebo; Other: Topical Placebo |
| Oral Placebo, Topical TC | Experimental | Oral Placebo, Topical TC on both forearms and dorsal hands Receives: Dietary Supplement: Placebo; Other: Topical Terminalia Chebula |
| Oral TC, Topical Placebo | Experimental | Oral TC, Topical Placebo on both forearms and dorsal hands Receives: Dietary Supplement: Terminalia Chebula fruit extract; Other: Topical Placebo |
| Oral TC, Topical TC | Experimental | Oral TC, Topical TC on both forearms and dorsal hands Receives: Dietary Supplement: Terminalia Chebula fruit extract; Other: Topical Terminalia Chebula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool microbiome diversity
Stool is collected and analyzed for species of bacteria through nucleic acid sequencing.
Measured: 8 weeks
Sebum production
Delfin Sebumeter: 0-150 micrograms/cm^2
Measured: 8 weeks
Secondary outcomes (13)
Transepidermal water loss
Delfin Vapometer 0-300g/m^2h
Measured: 8 weeks
Facial pigmentation
SkinColorCatchRGB range: 25-246 per channel
Measured: 8 weeks
Facial redness - Device Based
SkinColorCatch colorimeter RGB range: 25-246 per channel
Measured: 8 weeks
Facial wrinkles
BTBP Clarity Mini 3D camera: Wrinkle severity (depth and width measurement in unitless units)
Measured: 8 weeks
Facial shine
BTBP Clarity Mini 3D: (Surface reflection measured in unitless units)
Measured: 8 weeks
hand and arm pigmentation
SkinColorCatch colorimeter RGB range: 25-246 per channel
Measured: 8 weeks
hand and arm redness
SkinColorCatch colorimeter RGB range: 25-246 per channel
Measured: 8 weeks
Tolerability of Topical Products
Subjective Tolerability Questionnaire is collected
Measured: 8 weeks
Skin typing questionnaire
Subjective Questionnaire is collected
Measured: 8 weeks
Ayurvedic typing questionnaire
Subjective Questionnaire is collected
Measured: 8 weeks
Salivary diurnal cortisol slope
4 point salivary cortisol is measured over the course of a day
Measured: 8 weeks
Skin Hydration
Delfin MoisturemeterSC 0-150
Measured: 8 weeks
Facial Redness - Image Based
BTBP Clarity Mini 3D camera
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start15 Oct 2020
- Primary completion29 Mar 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sytheon Ltd.
- Responsible party
- Sponsor
- Investigators
- Raja K Sivamani, MD, Principal investigator, Integrative Skin Science and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597502
- Sponsor's protocol ID
- TC-0203
- Status last verified
- Nov 2022
- First submitted
- 9 Oct 2020
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Effects of Synastol TC (Standardized Terminalia Chebula Fruit Extract) on the Gut Microbiome and Skin Biophysical Properties"
- ClinicalTrials.gov ID
- NCT04597502
- Acronym / sponsor ID
- TC-0203
- Conditions
- Human Microbiome
- Keywords
- gut microbiome, skin, dermatology, terminalia chebula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Sytheon Ltd.
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 29 Mar 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oral Placebo, Topical Placebo | Placebo comparator | Dietary Supplement: Placebo, Other: Topical PlaceboOral Placebo, Topical Placebo on both forearms and dorsal hands |
| Oral Placebo, Topical TC | Experimental | Dietary Supplement: Placebo, Other: Topical Terminalia ChebulaOral Placebo, Topical TC on both forearms and dorsal hands |
| Oral TC, Topical Placebo | Experimental | Dietary Supplement: Terminalia Chebula fruit extract, Other: Topical PlaceboOral TC, Topical Placebo on both forearms and dorsal hands |
| Oral TC, Topical TC | Experimental | Dietary Supplement: Terminalia Chebula fruit extract, Other: Topical Terminalia ChebulaOral TC, Topical TC on both forearms and dorsal hands |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Females aged 25 to 55 years of age
- Subject must be able to read and comprehend study procedures and consent forms.
- BMI 25-35
Key exclusion criteria (15 listed)
- Subjects must have no history of malignancy, kidney disease, or chronic steroid use.
- No history of smoking or chewing tobacco or vaping nicotine based products within the past year or if the pack-year history of smoking tobacco is greater than 5 pack-years.
- No history of anorexia
- Those that are currently taking serotonin or SSRIs.
- No intake of pomegranate containing drinks, walnuts, and strawberries two weeks prior to enrollment and throughout the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Terminalia Chebula fruit extractOral TC fruit extract supplement taken by mouth twice per day | Dietary supplement | Oral TC, Topical Placebo, Oral TC, Topical TC |
| PlaceboOral placebo taken by mouth twice per day | Dietary supplement | Oral Placebo, Topical Placebo, Oral Placebo, Topical TC |
| Topical Terminalia ChebulaApplied to both forearms and dorsal hands | Other | Oral Placebo, Topical TC, Oral TC, Topical TC |
| Topical PlaceboApplied to both forearms and dorsal hands | Other | Oral Placebo, Topical Placebo, Oral TC, Topical Placebo |
Primary outcome
Stool microbiome diversity
Time frame: 8 weeks
Stool is collected and analyzed for species of bacteria through nucleic acid sequencing.
Sebum production
Time frame: 8 weeks
Delfin Sebumeter: 0-150 micrograms/cm^2
13 secondary outcomes
Transepidermal water loss
Time frame: 8 weeks
Facial pigmentation
Time frame: 8 weeks
Facial redness - Device Based
Time frame: 8 weeks
Facial wrinkles
Time frame: 8 weeks
Facial shine
Time frame: 8 weeks
hand and arm pigmentation
Time frame: 8 weeks
hand and arm redness
Time frame: 8 weeks
Tolerability of Topical Products
Time frame: 8 weeks
Skin typing questionnaire
Time frame: 8 weeks
Ayurvedic typing questionnaire
Time frame: 8 weeks
Salivary diurnal cortisol slope
Time frame: 8 weeks
Skin Hydration
Time frame: 8 weeks
Facial Redness - Image Based
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raja K Sivamani, MD principal investigator
Integrative Skin Science and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Terminalia Chebula fruit extract and Topical Terminalia Chebula in people with Human Microbiome, run by Integrative Skin Science and Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool microbiome diversity (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.