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Turmeric and Turmeric-containing Tablets and Sebum Production

Primary Purpose

Skin Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Turmeric
Turmeric-containing combination tablet
Placebo tablets
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Skin Inflammation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of California, Davis Dermatology Clinical Trials Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Turmeric group

Turmeric-containing combination tablets

Placebo tablets group

Arm Description

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.

• 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 1, 2016
Last Updated
December 18, 2018
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT03065504
Brief Title
Turmeric and Turmeric-containing Tablets and Sebum Production
Official Title
Pilot Study on the Effects of Oral Turmeric and Turmeric-containing Tablets on Sebum Production
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
August 28, 2017 (Actual)
Study Completion Date
August 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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 Ayurvedic 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Inflammation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Turmeric group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Turmeric-containing combination tablets
Arm Type
Active Comparator
Arm Description
• 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.
Arm Title
Placebo tablets group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Turmeric
Intervention Type
Dietary Supplement
Intervention Name(s)
Turmeric-containing combination tablet
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo tablets
Primary Outcome Measure Information:
Title
Change in facial Sebum production at 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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in sebum profile, such as inflammatory markers, at 4 weeks
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 to 50 years of age, and Subject must be able to read and comprehend study procedures and consent forms. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raja K Sivamani, M.D.
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis Dermatology Clinical Trials Unit
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17569219
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.
Results Reference
background
PubMed Identifier
12676044
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.
Results Reference
background
PubMed Identifier
30527287
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.
Results Reference
derived

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Turmeric and Turmeric-containing Tablets and Sebum Production

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