Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-04 @ 12:49 PM
Study NCT ID:
NCT03065504
Status:
COMPLETED
Last Update Posted:
2018-12-20
First Post:
2016-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Turmeric and Turmeric-containing Tablets and Sebum Production
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003872', 'term': 'Dermatitis'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003474', 'term': 'Curcumin'}], 'ancestors': [{'id': 'D036381', 'term': 'Diarylheptanoids'}, {'id': 'D006536', 'term': 'Heptanes'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-18', 'studyFirstSubmitDate': '2016-11-01', 'studyFirstSubmitQcDate': '2017-02-22', 'lastUpdatePostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in facial Sebum production at 4 weeks', 'timeFrame': '4 weeks', 'description': 'The investigators will use Sebutapes placed on the forehead to measure facial sebum production for 60 minutes at baseline and after 4 weeks. The tapes will collect the facial sebum produced during that time.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in sebum profile, such as inflammatory markers, at 4 weeks', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Skin Inflammation']}, 'referencesModule': {'references': [{'pmid': '17569219', 'type': 'BACKGROUND', 'citation': 'Thangapazham RL, Sharma A, Maheshwari RK. Beneficial role of curcumin in skin diseases. Adv Exp Med Biol. 2007;595:343-57. doi: 10.1007/978-0-387-46401-5_15.'}, {'pmid': '12676044', 'type': 'BACKGROUND', 'citation': 'Chainani-Wu N. Safety and anti-inflammatory activity of curcumin: a component of tumeric (Curcuma longa). J Altern Complement Med. 2003 Feb;9(1):161-8. doi: 10.1089/107555303321223035.'}, {'pmid': '30527287', 'type': 'DERIVED', 'citation': 'Vaughn AR, Pourang A, Clark AK, Burney W, Sivamani RK. Dietary supplementation with turmeric polyherbal formulation decreases facial redness: a randomized double-blind controlled pilot study. J Integr Med. 2019 Jan;17(1):20-23. doi: 10.1016/j.joim.2018.11.004. Epub 2018 Nov 22.'}]}, 'descriptionModule': {'briefSummary': 'A noticeably increasing number of patients are asking for naturally based extracts and ingredients as supplementary dermatologic remedies. Patients are seeking natural and cost-effective skin care alternatives in place of prescription medications and procedures. This study will isolate the effects of oral turmeric and assess a combination tablet that includes turmeric on sebum production in healthy subjects.', 'detailedDescription': "Turmeric (Curcuma longa) is a spice that has been shown to exhibit anti-inflammatory, antimicrobial, antioxidant, anti-neoplastic properties, and even potential to improve mental illnesses. In western herbalism, Turmeric is primarily used as an anti-inflammatory agent. In India, turmeric is used in Ayurvedic medicine for the treatment of acne. It has been used both internally and externally.\n\nCurcumin is a phytochemical derived from turmeric and believed to be one of the key active components of turmeric. Curcumin is reported to have activity as an antibacterial and anti-inflammatory agent and has been used as a paste for skin eruptions and infections. Previous basic science work by Dr. Raja Sivamani's lab has shown that both turmeric and curcumin inhibit lipid synthesis in human sebocytes, the cells responsible for the production of sebum\n\nThe goal of this study is to evaluate how ingestion of turmeric and tablets that have a combination of herbs including turmeric may modulate sebum production."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 to 50 years of age, and\n2. Subject must be able to read and comprehend study procedures and consent forms.\n\nExclusion Criteria:\n\n1. Subject should be generally healthy and have no smoking history in the past one year, and must have no history of diabetes, metabolic syndrome, known cardiovascular disease, malignancy, kidney disease, or chronic steroid use.\n2. Subjects who consume more than 6 servings of caffeine per day, such as coffee and energy drinks (example - Red Bull).\n3. Subjects with known allergies to herbal ingredients.\n4. Subjects with known EKG changes.\n5. Those who used topical medications in the past two weeks or systemic antibiotics within one month of starting the study.\n6. Subjects who are postmenopausal\n7. Those who are pregnant or breastfeeding.\n8. Those that are prisoners or cognitively impaired.'}, 'identificationModule': {'nctId': 'NCT03065504', 'briefTitle': 'Turmeric and Turmeric-containing Tablets and Sebum Production', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Pilot Study on the Effects of Oral Turmeric and Turmeric-containing Tablets on Sebum Production', 'orgStudyIdInfo': {'id': '948358'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Turmeric group', 'description': '2,000 mg turmeric per day - supplied by Banyan® Botanicals )\n\no Each tablet contains 500 mg of Turmeric (Curcuma longa). Subjects will take 2 tablets twice per day, with a total daily dose of 2,000 mg.', 'interventionNames': ['Dietary Supplement: Turmeric']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Turmeric-containing combination tablets', 'description': '• 2,000 mg Healthy Skin™ Tablets, contains:\n\n* Turmeric (Curcuma longa) - 50 mg/tablet\n* Hemidesmus Indicus root (Anantamul)\n* Indian Madder root\n* Neem leaf\n* Gotu Kola leaf\n* Indian TInospora stem\n* Amla fruit\n* Licorice root\n* Phyllanthus Amarus herb Each tablet contains 500mg total of the above herbs. There is 50 mg of Turmeric in each Healthy Skin ™ tablet. Subjects will take 2 tablets twice per day, which will be a total daily dose of 200 mg of Turmeric. This is comparable to the daily amount of Turmeric in many commercially-available Turmeric supplements; therefore, it is valuable to compare this formulation to the turmeric-only tablets.', 'interventionNames': ['Dietary Supplement: Turmeric-containing combination tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo tablets group', 'description': '* Supplement appearing similar to those in the turmeric and curcumin groups, supplied by Banyan® Botanicals\n* Ingredients (all organic): Placebo ingredients: Rice hulls concentrate, Maltodextrin, Micro Crystalline Cellulose, Beet Root Powder, Dutch coco powder\n* Dose: subjects in this group will take 2 tablets twice per day', 'interventionNames': ['Dietary Supplement: Placebo tablets']}], 'interventions': [{'name': 'Turmeric', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Turmeric group']}, {'name': 'Turmeric-containing combination tablet', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Turmeric-containing combination tablets']}, {'name': 'Placebo tablets', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo tablets group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis Dermatology Clinical Trials Unit', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Raja K Sivamani, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}