Turmeric and Turmeric-containing Tablets and Sebum Production

NCT03065504 | Completed

• 1 other identifier: 948358
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Inflammation

Outcome Measures

Primary Outcomes (1)

• Change in facial Sebum production at 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.

  4 weeks

Secondary Outcomes (1)

• Change from baseline in sebum profile, such as inflammatory markers, at 4 weeks

  4 weeks

Study Arms (3)

Turmeric group

ACTIVE COMPARATOR

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

Turmeric-containing combination tablets

ACTIVE COMPARATOR

• 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 tablets group

PLACEBO COMPARATOR

* 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

Interventions

Turmeric DIETARY_SUPPLEMENT

Turmeric group

Turmeric-containing combination tablet DIETARY_SUPPLEMENT

Turmeric-containing combination tablets

Placebo tablets DIETARY_SUPPLEMENT

Placebo tablets group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• Subjects who consume more than 6 servings of caffeine per day, such as coffee and energy drinks (example - Red Bull).
• Subjects with known allergies to herbal ingredients.
• Subjects with known EKG changes.
• Those who used topical medications in the past two weeks or systemic antibiotics within one month of starting the study.
• Subjects who are postmenopausal
• Those who are pregnant or breastfeeding.
• Those that are prisoners or cognitively impaired.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis Dermatology Clinical Trials Unit

Sacramento, California, 95816, United States

Location

Related Publications (3)

• 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: 17569219 BACKGROUND

• 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: 12676044 BACKGROUND

• 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.

  PMID: 30527287 DERIVED

MeSH Terms

Conditions

Dermatitis

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Raja K Sivamani, M.D.

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: February 28, 2017
• Study Start: November 1, 2016
• Primary Completion: August 28, 2017
• Study Completion: August 28, 2017
• Last Updated: December 20, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)