Recruiting

Musclin™

Sponsor:

Innovus Pharmaceuticals, Inc.

Code:

NCT03767504

Conditions

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Accepted

Interventions

Thymol

Study Details

Brief summary:

This study is to evaluate the effect and tolerance of a thymol containing dietary supplement, Musclin, in healthy adults.

Conditions

Healthy Volunteers

Study ID

NCT03767504

Start date

Nov 13, 2018

Status verified date

Dec, 2018

Completion date

Feb 28, 2019

Anticipated

Primary completion date

Feb 13, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Healthy volunteer > 40 years (adult)
2. Systolic blood pressure 90-140 mmHg upon screening
3. Subject has provided written informed consent
4. Subject is willing to undergo the procedures outlined in this study
5. Subjects BMI is within 18-28.
6. Subjects of childbearing potential must use a hormonal method of birth control, single-barrier method or a double-barrier method of birth control throughout the study or be documented as medically sterile.

Exclusion Criteria:

1. Subject has clinically significant deviation from normal in any organ system.
2. Subject has a clinically significant deviation from normal in any laboratory test except high cholesterol.
3. Pregnant, breastfeeding, or planned pregnancy during the study duration.
4. Known liver, renal or muscle diseases.
5. History of hypertensive or currently taking anti-hypertensive medications.
6. Presence or history of specific heart conditions.
7. Currently taking anti-thyroid or thyroid replacement medications.
8. Currently taking any creatinine kinase lowering drug or supplement.
9. Use of investigational drug within the previous 30 days.
10. Use of herbal supplements, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within 2 weeks prior to initial dosing.
11. Known allergies or intolerance to ingredients in Musclin™
12. Any condition which would interfere with the subject's ability to provide informed consent, to comply with study instructions, or which might confound the interpretation of the study results.

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Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Musclin

Thymol based dietary supplement

Interventions

Thymol

Musclin - a dietary supplement: 2 capsules (20 mg thymol per capsule) BID with a meal for 30 days increased to 4 capsules for an additional 30 days.

Primary outcome measure

  • Number of Participants with adverse events as a measure of tolerance [ Time Frame: Day 60 (End of Study) ]
  • Change in creatinine kinase [ Time Frame: Day 1(Baseline) to Day 60 (End of Study) ]
  • Change in myostatin levels [ Time Frame: Day 1(Baseline) to Day 60 (End of Study) ]

Central Contacts and Locations

Locations

Palm Beach Research Center

Recruiting

West Palm Beach, Florida, United States, 33409

Contacts

Principal Investigator:

Mira Baron, MD

More Information

Sponsor

Innovus Pharmaceuticals, Inc.

Last update posted

Dec 6, 2018

Last verified

Dec, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Innovus Pharmaceuticals, Inc. on 2018-12-06.