Healthy VolunteersNCT03767504
A Study to Evaluate the Effect and Tolerance of Musclin™ (Thymol) in Healthy Subjects
A study testing Thymol in people with Healthy Volunteers, run by Innovus Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This study is to evaluate the effect and tolerance of a thymol containing dietary supplement, Musclin, in healthy adults. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Thymol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2018to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteer > 40 years (adult)
- Systolic blood pressure 90-140 mmHg upon screening
- Subject has provided written informed consent
- Subject is willing to undergo the procedures outlined in this study
- Subjects BMI is within 18-28.
- 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.
Who cannot join
- Subject has clinically significant deviation from normal in any organ system.
- Subject has a clinically significant deviation from normal in any laboratory test except high cholesterol.
- Pregnant, breastfeeding, or planned pregnancy during the study duration.
- Known liver, renal or muscle diseases.
- History of hypertensive or currently taking anti-hypertensive medications.
- Presence or history of specific heart conditions.
Show all 13Show fewer
- Currently taking anti-thyroid or thyroid replacement medications.
- Currently taking any creatinine kinase lowering drug or supplement.
- Use of investigational drug within the previous 30 days.
- Use of herbal supplements, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within 2 weeks prior to initial dosing.
- Known allergies or intolerance to ingredients in Musclin™
- 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.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Palm Beach Research Center
West Palm Beach, Florida, 33409
Regina Waters, MA, 561-689-0606, regina@palmbeachresearch.com
Mira Baron, MD
About this study
Official title: An Open Label Study to Evaluate the Effect and Tolerance of Musclin™ (Thymol) in Healthy Subjects
This study is to evaluate the effect and tolerance of a thymol containing dietary supplement, Musclin, in healthy adults.
Read the detailed description
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.
- Conditions
- Healthy Volunteers
- Being tested
- Thymol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThymolDietary supplement
Also called Musclin
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.
| Study group | Role | What they receive |
|---|---|---|
| Musclin | Experimental | Thymol based dietary supplement Receives: Dietary Supplement: Thymol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with adverse events as a measure of tolerance
Measured: Day 60 (End of Study)
Change in creatinine kinase
Change in creatinine kinase measured in U/L
Measured: Day 1(Baseline) to Day 60 (End of Study)
Change in myostatin levels
Change in myostatin will be measured by blood samples using ELISA method.
Measured: Day 1(Baseline) to Day 60 (End of Study)
Secondary outcomes (3)
Changes in weight
Effect of supplement on weight (lbs)
Measured: Day 1(Baseline) to Day 60 (End of Study)
Change in cholesterol levels
Effect of supplement on cholesterol levels
Measured: Day 1(Baseline) to Day 60 (End of Study)
Number, type, and severity of adverse events
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start13 Nov 2018
- Primary completion13 Feb 2019 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, single arm, ascending dose
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767504
- Sponsor's protocol ID
- INNV-MS1000-001
- Status last verified
- Dec 2018
- First submitted
- 5 Dec 2018
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Evaluate the Effect and Tolerance of Musclin™ (Thymol) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03767504
- Acronym / sponsor ID
- INNV-MS1000-001
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Innovus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 13 Feb 2019 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the effect and tolerance of a thymol containing dietary supplement, Musclin, in healthy adults.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, single arm, ascending dose
| Arm | Type | Receives |
|---|---|---|
| Musclin | Experimental | Dietary Supplement: ThymolThymol based dietary supplement |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy volunteer > 40 years (adult)
- Systolic blood pressure 90-140 mmHg upon screening
- Subject has provided written informed consent
- Subject is willing to undergo the procedures outlined in this study
- Subjects BMI is within 18-28.
Key exclusion criteria (13 listed)
- Subject has clinically significant deviation from normal in any organ system.
- Subject has a clinically significant deviation from normal in any laboratory test except high cholesterol.
- Pregnant, breastfeeding, or planned pregnancy during the study duration.
- Known liver, renal or muscle diseases.
- History of hypertensive or currently taking anti-hypertensive medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThymolAlso: MusclinMusclin - 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. | Dietary supplement | Musclin |
Primary outcome
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 creatinine kinase measured in U/L
Change in myostatin levels
Time frame: Day 1(Baseline) to Day 60 (End of Study)
Change in myostatin will be measured by blood samples using ELISA method.
3 secondary outcomes
Changes in weight
Time frame: Day 1(Baseline) to Day 60 (End of Study)
Change in cholesterol levels
Time frame: Day 1(Baseline) to Day 60 (End of Study)
Number, type, and severity of adverse events
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Individual participant dataSharing planned: No
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Screening Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thymol in people with Healthy Volunteers, run by Innovus Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with adverse events as a measure of tolerance (time frame: Day 60 (End of Study)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2018.