NCT02762032

Brief Summary

This study will demonstrate the ability of the oral supplement, PrimaVie® to improve skin microperfusion, hydration, elasticity and barrier function. 45 females will be enrolled in 1 of 3 arms where they will receive either 125 mg PrimaVie, 250 mg PrimaVie or placebo (control) to take twice daily for 14 weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Feb 2016

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 21, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
6.5 years until next milestone

Results Posted

Study results publicly available

June 25, 2026

Completed
Last Updated

June 25, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

March 21, 2016

Results QC Date

March 5, 2026

Last Update Submit

June 1, 2026

Conditions

Healthy

Keywords

Skin BiopsyPrimaVieHerbal Supplement

Outcome Measures

Primary Outcomes (4)

  • Improvement in Non-invasive Skin Assessment of Skin Microperfusion

    To see the improvement in noninvasive skin assessment of objective measurements such as skin microperfusion (laser speckle contrast imaging) (scale Pu). An increase in PU means improved perfusion of the skin.

    14 weeks after oral supplementation

  • Improvement in Non-invasive Skin Assessment of Hydration

    To see the improvement in noninvasive skin assessment of objective measurements such as skin hydration using the DermaLab Combo Series (unit of micro-Siemens uS), which are arbitrary. An increase in uS means improved skin hydration and improved skin barrier function.

    14 weeks after oral supplementation

  • Improvement in Non-invasive Skin Assessment of Elasticity

    To see the improvement in noninvasive skin assessment of objective measurements such as skin elasticity using the DermaLab Combo Series (mega Pascal mPa). An increase in mPA means worsening of skin elasticity.

    14 weeks after oral supplementation

  • Improvement in Non-invasive Skin Assessment of Barrier Function

    To see the improvement in noninvasive skin assessment of objective measurements such as barrier function using Trans-Epidermal Water Loss (TEWL) using the DermaLab Combo Series (g/m2/h). An increase in these units indicates a worsening of TEWL, and reduction of the barrier function of the skin.

    14 weeks after oral supplementation

Other Outcomes (17)

  • Gene Chip Analysis- ITGA5 - Integrin Subunit Alpha 5

    14 weeks

  • Gene Chip Analysis: JAM3 - Junctional Adhesion Molecule 3

    14 weeks

  • Gene Chip Analysis - LGALS1 - Galectin 1

    14 weeks

  • +14 more other outcomes

Study Arms (3)

Arm 1

ACTIVE COMPARATOR

15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.

Dietary Supplement: PrimaVie Herbal Supplement 125

Arm 2

ACTIVE COMPARATOR

15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.

Dietary Supplement: PrimaVie Herbal Supplement 250

Arm 3

PLACEBO COMPARATOR

15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.

Drug: Placebo

Interventions

PrimaVie Herbal Supplement 125DIETARY_SUPPLEMENT

125 mg to take BID for 14 weeks in Arm 1

Also known as: PrimaVie
Arm 1
PrimaVie Herbal Supplement 250DIETARY_SUPPLEMENT

250 mg to take BID for 14 weeks in Arm 2

Also known as: PrimaVie
Arm 2
PlaceboDRUG

Placebo supplement to take BID for 14 weeks in Arm 3

Also known as: control supplement
Arm 3

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects willing to discontinue any dietary or nutritional supplements, other than a general multivitamin, starting two weeks before onset of study and also during the study.
  • Subjects must be willing to maintain their present diet with no major changes throughout the study.
  • Subjects must be willing to take the dietary supplements as required by the study protocol twice daily.
  • Female subjects must be between the ages of 30 to 65 years of age
  • Subjects must provide written informed consent and are willing to comply with all study procedures.

You may not qualify if:

  • Any dermatological disorder that may interfere with the accurate evaluation of the subject's skin.
  • Subjects who are pregnant, breast feeding, or planning a pregnancy.
  • Clinically significant unstable medical disorders.
  • History of, diabetes, heart or kidney disease
  • History of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study.
  • Any skin disease in the area of the upper inner arm where the biopsies will be obtained.
  • Currently taking the following medications:
  • Steroids
  • Beta-blockers
  • Immunosuppressant's
  • Hydochlorothiazide,
  • Statins
  • Aspirin
  • ACE Inhibitors
  • Muscle relaxants
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

OSU Hospital East

Columbus, Ohio, 43205, United States

Location

Davis Heart and Lung Research Institute

Columbus, Ohio, 43210, United States

Location

Martha Morehouse Medical Plaza 2050 Kenny Road

Columbus, Ohio, 43221, United States

Location

Related Publications (1)

  • Das A, S El Masry M, Gnyawali SC, Ghatak S, Singh K, Stewart R, Lewis M, Saha A, Gordillo G, Khanna S. Skin Transcriptome of Middle-Aged Women Supplemented With Natural Herbo-mineral Shilajit Shows Induction of Microvascular and Extracellular Matrix Mechanisms. J Am Coll Nutr. 2019 Aug;38(6):526-536. doi: 10.1080/07315724.2018.1564088. Epub 2019 Jun 4.

    PMID: 31161927DERIVED

Results Point of Contact

Title
Gayle Gordillo, MD
Organization
Indiana University
Amym@iu.edu
3172782720

Study Officials

  • Gayle M Gordillo, M.D.

    Indiana University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 21, 2016

First Posted

May 4, 2016

Study Start

February 20, 2016

Primary Completion

December 1, 2018

Study Completion

December 20, 2019

Last Updated

June 25, 2026

Results First Posted

June 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)