Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT04597502
Status:
COMPLETED
Last Update Posted:
2022-11-15
First Post:
2020-10-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Terminalia Chebula Fruit Extract on the Gut Microbiome and Skin Biophysical Properties
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713171', 'term': 'chebulae fruit'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Double-blinded placebo controlled'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-13', 'studyFirstSubmitDate': '2020-10-09', 'studyFirstSubmitQcDate': '2020-10-15', 'lastUpdatePostDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stool microbiome diversity', 'timeFrame': '8 weeks', 'description': 'Stool is collected and analyzed for species of bacteria through nucleic acid sequencing.'}, {'measure': 'Sebum production', 'timeFrame': '8 weeks', 'description': 'Delfin Sebumeter: 0-150 micrograms/cm\\^2'}], 'secondaryOutcomes': [{'measure': 'Transepidermal water loss', 'timeFrame': '8 weeks', 'description': 'Delfin Vapometer 0-300g/m\\^2h'}, {'measure': 'Facial pigmentation', 'timeFrame': '8 weeks', 'description': 'SkinColorCatchRGB range: 25-246 per channel'}, {'measure': 'Facial redness - Device Based', 'timeFrame': '8 weeks', 'description': 'SkinColorCatch colorimeter RGB range: 25-246 per channel'}, {'measure': 'Facial wrinkles', 'timeFrame': '8 weeks', 'description': 'BTBP Clarity Mini 3D camera: Wrinkle severity (depth and width measurement in unitless units)'}, {'measure': 'Facial shine', 'timeFrame': '8 weeks', 'description': 'BTBP Clarity Mini 3D: (Surface reflection measured in unitless units)'}, {'measure': 'hand and arm pigmentation', 'timeFrame': '8 weeks', 'description': 'SkinColorCatch colorimeter RGB range: 25-246 per channel'}, {'measure': 'hand and arm redness', 'timeFrame': '8 weeks', 'description': 'SkinColorCatch colorimeter RGB range: 25-246 per channel'}, {'measure': 'Tolerability of Topical Products', 'timeFrame': '8 weeks', 'description': 'Subjective Tolerability Questionnaire is collected'}, {'measure': 'Skin typing questionnaire', 'timeFrame': '8 weeks', 'description': 'Subjective Questionnaire is collected'}, {'measure': 'Ayurvedic typing questionnaire', 'timeFrame': '8 weeks', 'description': 'Subjective Questionnaire is collected'}, {'measure': 'Salivary diurnal cortisol slope', 'timeFrame': '8 weeks', 'description': '4 point salivary cortisol is measured over the course of a day'}, {'measure': 'Skin Hydration', 'timeFrame': '8 weeks', 'description': 'Delfin MoisturemeterSC 0-150'}, {'measure': 'Facial Redness - Image Based', 'timeFrame': '8 weeks', 'description': 'BTBP Clarity Mini 3D camera'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gut microbiome', 'skin', 'dermatology', 'terminalia chebula'], 'conditions': ['Human Microbiome']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Females aged 25 to 55 years of age\n2. Subject must be able to read and comprehend study procedures and consent forms.\n3. BMI 25-35\n\nExclusion Criteria:\n\n1. Subjects must have no history of malignancy, kidney disease, or chronic steroid use.\n2. 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.\n3. No history of anorexia\n4. Those that are currently taking serotonin or SSRIs.\n5. No intake of pomegranate containing drinks, walnuts, and strawberries two weeks prior to enrollment and throughout the study\n6. Those who are unable to discontinue topical medications for two weeks.\n7. 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\n8. 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.\n9. Those who are unable to discontinue systemic antibiotics or oral probiotics for one month prior starting the study.\n10. Those who are unable to discontinue their Triphala or Terminalia chebula regimen for one month prior to starting study.\n11. Subjects who are postmenopausal or perimenopausal as determined by the investigator based on history or documented menopause\n12. Males will be excluded to reduce the contribution from gender-based differences in testosterone which can affect sebum production on the face.\n13. Those who are pregnant or breastfeeding\n14. Those that are prisoners or cognitively impaired\n15. Those who have a known allergy to Triphala or Terminalia chebula'}, 'identificationModule': {'nctId': 'NCT04597502', 'briefTitle': 'The Effects of Terminalia Chebula Fruit Extract on the Gut Microbiome and Skin Biophysical Properties', 'organization': {'class': 'INDUSTRY', 'fullName': 'Integrative Skin Science and Research'}, 'officialTitle': '"The Effects of Synastol TC (Standardized Terminalia Chebula Fruit Extract) on the Gut Microbiome and Skin Biophysical Properties"', 'orgStudyIdInfo': {'id': 'TC-0203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Oral Placebo, Topical Placebo', 'description': 'Oral Placebo, Topical Placebo on both forearms and dorsal hands', 'interventionNames': ['Dietary Supplement: Placebo', 'Other: Topical Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Oral Placebo, Topical TC', 'description': 'Oral Placebo, Topical TC on both forearms and dorsal hands', 'interventionNames': ['Dietary Supplement: Placebo', 'Other: Topical Terminalia Chebula']}, {'type': 'EXPERIMENTAL', 'label': 'Oral TC, Topical Placebo', 'description': 'Oral TC, Topical Placebo on both forearms and dorsal hands', 'interventionNames': ['Dietary Supplement: Terminalia Chebula fruit extract', 'Other: Topical Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Oral TC, Topical TC', 'description': 'Oral TC, Topical TC on both forearms and dorsal hands', 'interventionNames': ['Dietary Supplement: Terminalia Chebula fruit extract', 'Other: Topical Terminalia Chebula']}], 'interventions': [{'name': 'Terminalia Chebula fruit extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral TC fruit extract supplement taken by mouth twice per day', 'armGroupLabels': ['Oral TC, Topical Placebo', 'Oral TC, Topical TC']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral placebo taken by mouth twice per day', 'armGroupLabels': ['Oral Placebo, Topical Placebo', 'Oral Placebo, Topical TC']}, {'name': 'Topical Terminalia Chebula', 'type': 'OTHER', 'description': 'Applied to both forearms and dorsal hands', 'armGroupLabels': ['Oral Placebo, Topical TC', 'Oral TC, Topical TC']}, {'name': 'Topical Placebo', 'type': 'OTHER', 'description': 'Applied to both forearms and dorsal hands', 'armGroupLabels': ['Oral Placebo, Topical Placebo', 'Oral TC, Topical Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Integrative Skin Science and Research', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Raja K Sivamani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Integrative Skin Science and Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Integrative Skin Science and Research', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sytheon Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}