<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03767504</url>
  </required_header>
  <id_info>
    <org_study_id>INNV-MS1000-001</org_study_id>
    <nct_id>NCT03767504</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Effect and Tolerance of Musclin™ (Thymol) in Healthy Subjects</brief_title>
  <official_title>An Open Label Study to Evaluate the Effect and Tolerance of Musclin™ (Thymol) in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Innovus Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Innovus Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to evaluate the effect and tolerance of a thymol containing dietary supplement,&#xD;
      Musclin, in healthy adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be an open label, uncontrolled, ascending dose clinical trial to assess the&#xD;
      tolerance and effect of orally ingested Musclin, 20 mg thymol per capsule, in healthy adult&#xD;
      subjects. In addition, this study will evaluate whether Musclin has an effect on creatine&#xD;
      kinase and myostatin levels. The study will aim to enroll 20 consenting men and women.&#xD;
      Consented subjects will ingest 2 capsules of Musclin daily for 30 days and increase to 4&#xD;
      capsules daily for an additional 30 days . Physical assessments and biological samples will&#xD;
      be collected at baseline (day 0) and at end of treatment (d 60). Surveys to include reported&#xD;
      stamina and energy levels will be collected at baseline, prior to increased dosage (d 30) and&#xD;
      end of treatment period. Risk to participants is expected to be minimal and will be outlined&#xD;
      through an informed consent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 13, 2018</start_date>
  <completion_date type="Anticipated">February 28, 2019</completion_date>
  <primary_completion_date type="Anticipated">February 13, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Open label, single arm, ascending dose</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with adverse events as a measure of tolerance</measure>
    <time_frame>Day 60 (End of Study)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in creatinine kinase</measure>
    <time_frame>Day 1(Baseline) to Day 60 (End of Study)</time_frame>
    <description>Change in creatinine kinase measured in U/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in myostatin levels</measure>
    <time_frame>Day 1(Baseline) to Day 60 (End of Study)</time_frame>
    <description>Change in myostatin will be measured by blood samples using ELISA method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in weight</measure>
    <time_frame>Day 1(Baseline) to Day 60 (End of Study)</time_frame>
    <description>Effect of supplement on weight (lbs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cholesterol levels</measure>
    <time_frame>Day 1(Baseline) to Day 60 (End of Study)</time_frame>
    <description>Effect of supplement on cholesterol levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number, type, and severity of adverse events</measure>
    <time_frame>60 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Musclin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thymol based dietary supplement</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Thymol</intervention_name>
    <description>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.</description>
    <arm_group_label>Musclin</arm_group_label>
    <other_name>Musclin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy volunteer &gt; 40 years (adult)&#xD;
&#xD;
          2. Systolic blood pressure 90-140 mmHg upon screening&#xD;
&#xD;
          3. Subject has provided written informed consent&#xD;
&#xD;
          4. Subject is willing to undergo the procedures outlined in this study&#xD;
&#xD;
          5. Subjects BMI is within 18-28.&#xD;
&#xD;
          6. Subjects of childbearing potential must use a hormonal method of birth control,&#xD;
             single-barrier method or a double-barrier method of birth control throughout the study&#xD;
             or be documented as medically sterile.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has clinically significant deviation from normal in any organ system.&#xD;
&#xD;
          2. Subject has a clinically significant deviation from normal in any laboratory test&#xD;
             except high cholesterol.&#xD;
&#xD;
          3. Pregnant, breastfeeding, or planned pregnancy during the study duration.&#xD;
&#xD;
          4. Known liver, renal or muscle diseases.&#xD;
&#xD;
          5. History of hypertensive or currently taking anti-hypertensive medications.&#xD;
&#xD;
          6. Presence or history of specific heart conditions.&#xD;
&#xD;
          7. Currently taking anti-thyroid or thyroid replacement medications.&#xD;
&#xD;
          8. Currently taking any creatinine kinase lowering drug or supplement.&#xD;
&#xD;
          9. Use of investigational drug within the previous 30 days.&#xD;
&#xD;
         10. Use of herbal supplements, and/or over-the-counter (OTC) medication, dietary&#xD;
             supplements (vitamins included) within 2 weeks prior to initial dosing.&#xD;
&#xD;
         11. Known allergies or intolerance to ingredients in Musclin™&#xD;
&#xD;
         12. Any condition which would interfere with the subject's ability to provide informed&#xD;
             consent, to comply with study instructions, or which might confound the interpretation&#xD;
             of the study results.&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Palm Beach Research Center</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33409</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Regina Waters, MA</last_name>
      <phone>561-689-0606</phone>
      <email>regina@palmbeachresearch.com</email>
    </contact>
    <investigator>
      <last_name>Mira Baron, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thymol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03767504
org study id: INNV-MS1000-001
nct id: NCT03767504
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is to evaluate the effect and tolerance of a thymol containing dietary supplement,
      Musclin, in healthy adults.
This study will be an open label, uncontrolled, ascending dose clinical trial to assess the
      tolerance and effect of orally ingested Musclin, 20 mg thymol per capsule, in healthy adult
      subjects. In addition, this study will evaluate whether Musclin has an effect on creatine
      kinase and myostatin levels. The study will aim to enroll 20 consenting men and women.
      Consented subjects will ingest 2 capsules of Musclin daily for 30 days and increase to 4
      capsules daily for an additional 30 days . Physical assessments and biological samples will
      be collected at baseline (day 0) and at end of treatment (d 60). Surveys to include reported
      stamina and energy levels will be collected at baseline, prior to increased dosage (d 30) and
      end of treatment period. Risk to participants is expected to be minimal and will be outlined
      through an informed consent.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Open label, single arm, ascending dose
primary purpose: Other
masking: None (Open Label)
measure: Number of Participants with adverse events as a measure of tolerance
time frame: Day 60 (End of Study)
measure: Change in creatinine kinase
time frame: Day 1(Baseline) to Day 60 (End of Study)
description: Change in creatinine kinase measured in U/L
measure: Change in myostatin levels
time frame: Day 1(Baseline) to Day 60 (End of Study)
description: Change in myostatin will be measured by blood samples using ELISA method.
measure: Changes in weight
time frame: Day 1(Baseline) to Day 60 (End of Study)
description: Effect of supplement on weight (lbs)
measure: Change in cholesterol levels
time frame: Day 1(Baseline) to Day 60 (End of Study)
description: Effect of supplement on cholesterol levels
measure: Number, type, and severity of adverse events
time frame: 60 days
arm group label: Musclin
arm group type: Experimental
description: Thymol based dietary supplement
intervention type: Dietary Supplement
intervention name: Thymol
description: 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.
arm group label: Musclin
other name: Musclin
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Thymol
sharing ipd: No