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Turmeric and Turmeric-containing Tablets and Sebum Production

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by University of California, Davis
Sponsor:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT03065504
First received: November 1, 2016
Last updated: July 17, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention
Skin Inflammation Dietary Supplement: Turmeric Dietary Supplement: Turmeric-containing combination tablet Dietary Supplement: Placebo tablets

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Basic Science
Official Title: Pilot Study on the Effects of Oral Turmeric and Turmeric-containing Tablets on Sebum Production

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Change in facial Sebum production at 4 weeks [ Time Frame: 4 weeks ]
    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.


Secondary Outcome Measures:
  • Change from baseline in sebum profile, such as inflammatory markers, at 4 weeks [ Time Frame: 4 weeks ]

Estimated Enrollment: 30
Study Start Date: November 2016
Estimated Study Completion Date: October 23, 2017
Estimated Primary Completion Date: October 23, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Turmeric group

2,000 mg turmeric per day - supplied by Banyan® Botanicals )

o 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.

Dietary Supplement: Turmeric
Active Comparator: Turmeric-containing combination tablets

• 2,000 mg Healthy Skin™ Tablets, contains:

  • Turmeric (Curcuma longa) - 50 mg/tablet
  • Hemidesmus Indicus root (Anantamul)
  • Indian Madder root
  • Neem leaf
  • Gotu Kola leaf
  • Indian TInospora stem
  • Amla fruit
  • Licorice root
  • 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.
Dietary Supplement: Turmeric-containing combination tablet
Placebo Comparator: Placebo tablets group
  • Supplement appearing similar to those in the turmeric and curcumin groups, supplied by Banyan® Botanicals
  • Ingredients (all organic): Placebo ingredients: Rice hulls concentrate, Maltodextrin, Micro Crystalline Cellulose, Beet Root Powder, Dutch coco powder
  • Dose: subjects in this group will take 2 tablets twice per day
Dietary Supplement: Placebo tablets

Detailed Description:

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 Ayurevdic medicine for the treatment of acne. It has been used both internally and externally.

Curcumin 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

The 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18 to 50 years of age, and
  2. Subject must be able to read and comprehend study procedures and consent forms.

Exclusion Criteria:

  1. 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.
  2. Subjects who consume more than 6 servings of caffeine per day, such as coffee and energy drinks (example - Red Bull).
  3. Subjects with known allergies to herbal ingredients.
  4. Subjects with known EKG changes.
  5. Those who used topical medications in the past two weeks or systemic antibiotics within one month of starting the study.
  6. Subjects who are postmenopausal
  7. Those who are pregnant or breastfeeding.
  8. Those that are prisoners or cognitively impaired.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03065504

Contacts
Contact: Alexandra R Vaughn, B.S. 916-221-0441 missallievaughn@gmail.com

Locations
United States, California
University of California, Davis Dermatology Clinical Trials Unit Recruiting
Sacramento, California, United States, 95816
Contact: Manisha Notay, MBBS    916-734-6550    mnotay@ucdavis.edu   
Principal Investigator: Raja Sivamani, MD MS CAT         
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Raja K Sivamani, M.D. University of California, Davis
  More Information

Publications:
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03065504     History of Changes
Other Study ID Numbers: 948358
Study First Received: November 1, 2016
Last Updated: July 17, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Inflammation
Dermatitis
Pathologic Processes
Skin Diseases
Turmeric extract
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2017