Delayed Onset Muscle Soreness (DOMS)Phase 2NCT07809282
A Study of Mitragynine Formulations for Exercise-Induced Muscle Soreness in Healthy Adults
A Phase 2 study testing SpecioTea and MitraPlex in people with Delayed Onset Muscle Soreness (DOMS) and Exercise-Induced Muscle Soreness, run by Traditional Naturals Research Inc. at 1 site in Canada.
Trial summary
This Phase II randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, and physical dependence potential of mitragynine-containing formulations after 28 days of use and assess their effects on exercise-induced muscle soreness in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Delayed Onset Muscle Soreness (DOMS), Exercise-Induced Muscle Soreness
- What is being tested?
- SpecioTea and MitraPlex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 5 Feb 2025to 22 Oct 2025
- Phase
- Phase 2
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females who are 18 to 55 years of age (inclusive).
- In good general health as deemed by the investigator and are able to consume the study product.
- Have a BMI between 18.0 to 34.9 kg/m2 (inclusive).
- Naïve to kratom use or occasional kratom use (i.e., have not used kratom more than once within 28 days prior to baseline [Visit 2]).
- Non-smokers (including nicotine vaping) and have not used nicotine-containing products (patches, gums, etc.) for > 3 months prior to baseline (Visit Note: Non-smoker is defined as someone who does not habitually/regularly use products containing nicotine.
- Appropriate for exercise as determined by the PAR-Q at screening (Visit 1A).
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- Demonstrate DOMS 48 h post-exercise by having a VAS ≥ 40 mm after completion of the exercise challenge at Visit 1A.
- Agree to follow the restrictions on concomitant treatments.
- Agree to follow the restrictions on lifestyle (especially regarding physical activity).
- Agree to use acceptable contraceptive methods.
- Have suitable veins for repeated venipuncture as deemed by the investigator.
- Have maintained consistent dietary habits (including medication and supplement intake), exercise and lifestyle habits for the last 3 months before screening (Visit 1A) and agree to maintain them throughout the study (unless required per the restrictions).
- Willing and able to agree to the requirements of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.
Who cannot join
- Individuals who are lactating, planning to become pregnant during the study, or pregnancy as confirmed by a positive urine pregnancy test at screening Visit 1A or Visit 2.
- Have a positive drug screen for any of the compounds listed as confirmed at screening Visit 1A or Visit 2.
- Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients, or the rescue medication, NARCAN® (naloxone).
- Current COVID-19 infections, or currently have the post COVID-19 condition as defined by World Health Organization (WHO) (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis).
- Have exercised regularly (generally > 150 cumulative minutes per week) for 6 months prior to screening (Visit 1A) and/or Visit 2.
- Have engaged in regular lower extremity fitness activities (e.g., running, cycling, soccer or hockey) for more than two times per week for ≥ 2 consecutive weeks in the past 6 months prior to screening (Visit 1A) and/or Visit 2.
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- Had lower body surgery (e.g., hips, knees, ankles, etc.) within 6 months prior to screening (Visit 1A) and/or planned lower body surgery during the study.
- History of any lower body injury [e.g., partial anterior cruciate ligament (ACL) tear, broken or fractured bone, major sprain] within 6 months prior to screening (Visit 1A) and/or during the study.
- Have Type I/Type II diabetes or thyroid disease.
- Have uncontrolled or controlled high blood pressure (≥140 systolic or ≥90 diastolic mmHg) at screening.
- Have medical condition(s) known to interfere with absorption, distribution, metabolism, or excretion of the study product (e.g., Crohn's disease, short bowel, acute or chronic pancreatitis, or pancreatic insufficiency).
- Have a history of heart/cardiovascular disease, immune disorders and/or immunocompromised (i.e., HIV/AIDS).
- Have active asthma or have experienced an asthma attack in the last 5 years.
- Have a history of neurological disorders such as epilepsy.
- Have hepatic or renal dysfunction as evidenced by ALT and/or AST being ≥ 2 times the upper limit of normal (ULN), serum creatinine or urea value ≥ 1.5 times the ULN, or other clinically significant abnormal clinical laboratory value per investigator discretion.
- Have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer), unless recovery occurred more than 5 years before the screening visit.
- Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.).
- Have known genetic polymorphisms of CYP450, CYP3A4, CYP2D6, and/or CYP1A2 enzymes.
- Reports a clinically significant illness during the 28 days before the first dose of study product.
- Major surgery in 3 months prior to screening or planned major surgery during the study.
- Reports a significant blood loss or blood donation totaling between 101 mL to 449 mL of blood within 30 days prior to Visit 2 or a blood donation of more than 450 mL within 56 days prior to Visit 2.
- Reports donating plasma (e.g., plasmapheresis) within 15 days prior to Visit 2.
- Have a history of alcohol or substance abuse in the 12 months prior to Visit 1A (including having been hospitalized for such in an in-patient or out-patient intervention program) or use that to the opinion of the investigator may be of a concern for the study.
- Currently consumes more than 2 standard alcoholic beverages per day on average for 4 weeks prior to Visit 1A. A standard alcoholic beverage is defined as 12 ounces of beer, 5 ounces of wine or 1.5 ounces of liquor.
- Evidence of addictive tendency as indicated by an LDQ score ≥ 21 at Visit 1A.
- Current enrolment or past participation in another study with any product(s) with at least one active ingredient within 28 days before Visit 1A or longer, if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study.
- Living in the same household as another currently/previously enrolled participant in the present study.
- Any other medical condition/situation or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to participate in the study or its measures or pose a significant risk to the participant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Tolerability of Product Formulations Containing Mitragynine and Their Relative Effects on Exercise-induced Muscle Soreness in Healthy Adult Participants.
This Phase II randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, and physical dependence potential of mitragynine-containing formulations after 28 days of use and assess their effects on exercise-induced muscle soreness in healthy adults. One hundred participants will be randomized in a 1:1:1:1 ratio to SpecioTea 20 mg, SpecioTea 40 mg, MitraPlex 20 mg, or placebo. Participants will complete an exercise challenge to induce delayed-onset muscle soreness (DOMS), undergo efficacy assessments at 24 and 48 hours post-exercise, and continue daily dosing for approximately 28 days followed by withdrawal and safety assessments.
Read the detailed description
This Phase II study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, tolerability, and potential physical dependence associated with two mitragynine-containing formulations (SpecioTea and MitraPlex), while also assessing their efficacy in reducing exercise-induced muscle soreness in healthy adults. Participants will be randomized in a 1:1:1:1 ratio to receive SpecioTea 20 mg, SpecioTea 40 mg, MitraPlex 20 mg, or placebo. The study will enroll approximately 100 healthy adults aged 18 to 55 years who are naïve to kratom use or occasional kratom users and who demonstrate delayed-onset muscle soreness (DOMS) following a screening exercise challenge. Randomization will be stratified by sex.
The study duration for each participant will be approximately 11.5 weeks and will consist of a screening period, an acute efficacy phase, a 28-day supplementation period, and post-treatment follow-up assessments. During screening, participants will complete an exercise challenge designed to induce DOMS. Forty-eight hours later, participants will complete a Visual Analogue Scale (VAS) assessment remotely to confirm the presence of muscle soreness and eligibility for enrollment. Eligible participants will return for the baseline visit at least 27 days after the screening exercise challenge.
At baseline, participants will undergo efficacy and safety assessments, including vital signs, laboratory testing, muscle soreness assessment, strength assessment, range of motion measurements, and evaluations using the Subjective Opiate Withdrawal Scale (SOWS) and Clinical Opiate Withdrawal Scale (COWS). Participants will then receive their assigned study intervention and consume the first dose in clinic. Between 45 and 90 minutes after dosing, participants will complete a standardized exercise challenge intended to induce muscle soreness. Biomarkers of muscle damage, including creatine kinase, lactate dehydrogenase, myoglobin, and creatinine, will be measured before and after exercise. Participants will return approximately 24 and 48 hours after the exercise challenge for additional assessments of muscle soreness, muscle strength, range of motion, and biomarkers of muscle damage.
Following completion of the acute exercise phase, participants will begin once-daily at-home dosing for 28 ± 2 days. Participants assigned to active treatment will receive either SpecioTea or MitraPlex capsules providing 20 mg or 40 mg of mitragynine per day, depending on randomization group. Participants assigned to placebo will receive matching placebo capsules. All participants will consume four capsules daily, and study products will be visually identical to maintain blinding.
The primary objective is to evaluate safety and tolerability after 28 days of continued use. Safety assessments include adverse event monitoring, vital signs, body weight, body mass index, hematology and clinical chemistry laboratory evaluations, and assessments of potential withdrawal symptoms using the SOWS and COWS instruments. Safety laboratory assessments include hematology parameters and clinical chemistry measures such as liver function tests, kidney function markers, electrolytes, glucose, and protein measurements.
Secondary and exploratory objectives are to evaluate the effects of the study interventions on exercise-induced muscle soreness, joint stiffness, muscle strength, and biomarkers of muscle damage. Efficacy outcomes include changes from baseline in VAS scores, knee range of motion, one-repetition maximum (1-RM) strength measures, and serum concentrations of creatine kinase, lactate dehydrogenase, myoglobin, and creatinine following exercise. Assessments will be performed at baseline and at multiple post-exercise timepoints to characterize treatment effects relative to placebo.
After completion of the 28-day dosing period, participants will return for follow-up visits to evaluate safety, collect laboratory data, assess treatment compliance, and monitor for withdrawal symptoms. Follow-up visits will occur the day after the last dose, 2 days later, and 13 days later. These visits will include SOWS and COWS assessments, review of concomitant medications, evaluation of changes in health status, and monitoring for adverse events. The study is intended to provide information regarding the safety profile of mitragynine-containing products and their potential utility in reducing post-exercise muscle soreness in healthy adults.
- Being tested
- SpecioTea, MitraPlex, Placebo
- Keywords
- Mitragynine, Delayed Onset Muscle Soreness (DOMS), Exercise-Induced Muscle Soreness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpecioTeaDietary supplement
SpecioTea is a dried aqueous kratom leaf extract administered orally in capsule form. Participants receive 4 capsules once daily. The study evaluates two dosage levels: 20 mg mitragynine daily (2 active capsules plus 2 placebo capsules) and 40 mg mitragynine daily (4 active capsules).
MitraPlexDietary supplement
MitraPlex is a dried ethanolic/water kratom leaf extract administered orally in capsule form. Participants receive 4 active capsules once daily providing a total daily dose of 20 mg mitragynine.
PlaceboOther
Matching placebo capsules administered orally. Participants receive 4 placebo capsules once daily. Placebo capsules are visually indistinguishable from active study product capsules to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| SpecioTea 20 mg | Experimental | Participants receive 4 capsules daily containing a total of 20 mg mitragynine (2 active capsules plus 2 placebo capsules). Receives: Dietary Supplement: SpecioTea |
| SpecioTea 40 mg | Experimental | Participants receive 4 active capsules daily containing a total of 40 mg mitragynine. Receives: Dietary Supplement: SpecioTea |
| MitraPlex 20 mg | Experimental | Participants receive 4 active capsules daily containing a total of 20 mg mitragynine. Receives: Dietary Supplement: MitraPlex |
| Placebo | Placebo comparator | Participants receive 4 placebo capsules daily. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability After 28 Days of Use (Vitals)
Heart Rate (bpm)
Measured: Baseline through Visit 7 (approximately 45 days) with primary safety assessment after 28 ± 2 days of dosing.
Safety and Tolerability After 28 Days of Use (Vitals)
Blood Pressure (mmHg)
Measured: Baseline through Visit 7 (approximately 45 days) with primary safety assessment after 28 ± 2 days of dosing.
To assess the effect of each TP intervention on changes in creatinine compared to each other and to a placebo
Change in concentration of creatinine
Measured: Change from baseline to 1 hour, 24 hours, and 48 hours post-exercise
To assess the effect of each TP intervention on changes in myoglobin compared to each other and to a placebo
Change in concentration of myoglobin
Measured: Change from baseline to 1 hour, 24 hours, and 48 hours post-exercise
To assess the effect of each TP intervention on changes in lactose dehydrogenase (LDH) compared to each other and to a placebo
Change in concentration of LDH
Measured: Change from baseline to 1 hour, 24 hours, and 48 hours post-exercise
To assess the effect of each TP intervention on changes in CK compared to each other and to a placebo
Change in concentration of creatine kinase (CK)
Measured: Change from baseline to 1 hour, 24 hours, and 48 hours post-exercise
To assess the effect of each TP intervention on muscle strength after intense exercise compared to each other and to a placebo
Change in the maximum weight moved
Measured: Change from baseline to 24 hours and 48 hours post-exercise
To assess the effect of each TP intervention on reducing joint stiffness after intense exercise compared to each other and to a placebo
Change in the magnitude of joint range of motion (degrees)
Measured: Change from baseline to 24 hours and 48 hours post-exercise
To assess the efficacy of each TP intervention on reducing exercise-induced muscle soreness at 24 h and 48 h post-exercise compared to each other and to a placebo
Change in Visual Analog Scale score. Participants will draw a vertical line on 100 mm scale that represents the current intensity of their pain where left end of the scale is representative of "no soreness at all" and the right end of the scale is representative of "extreme soreness". The intensity of pain will be considered to be the distance (in mm) of the participant's mark from the left-hand side of the scale.
Measured: Change from baseline to 24 hours and to 48 hours post-exercise
Safety and Tolerability After 28 Days of Use (Anthropometrics)
Assessment of Body weight (kg)
Measured: Baseline through Visit 7 (approximately 45 days) with primary safety assessment after 28 ± 2 days of dosing.
Safety and Tolerability After 28 Days of Use (Anthropometrics)
Assessment of BMI (kg/m2)
Measured: Baseline through Visit 7 (approximately 45 days) with primary safety assessment after 28 ± 2 days of dosing.
Safety and Tolerability After 28 Days of Use (Laboratory Blood Tests)
Blood samples will be collected to assess hematology parameters (hemoglobin, hematocrit, red blood cell [RBC], red blood cell distribution width [RDW], RBC indices [mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), MCH concentration (MCHC)], white blood cells [WBC] with differential [abs], platelet count, mean platelet volume [MPV]).
Measured: Baseline through Visit 7 (approximately 45 days) with primary safety assessment after 28 ± 2 days of dosing.
Safety and Tolerability After 28 Days of Use (Laboratory Blood Tests)
Change from baseline in clinical chemistry laboratory parameters. Blood samples will be collected to assess clinical chemistry parameters including urea, creatinine, total bilirubin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), random serum glucose, albumin, globulin, total protein, sodium, potassium, estimated glomerular filtration rate (eGFR), and chloride. Each laboratory parameter will be evaluated and reported separately according to its standard unit of measurement, with change from baseline summarized for each parameter.
Measured: Baseline through Visit 7 (approximately 45 days) with primary safety assessment after 28 ± 2 days of dosing.
Safety and Tolerability After 28 Days of Use (Adverse Events)
Reports of AEs
Measured: Baseline through Visit 7 (approximately 45 days) with primary safety assessment after 28 ± 2 days of dosing.
Safety and Tolerability After 28 Days of Use (SOWS)
Changes in Subjective Opiate Withdrawal Scale (SOWS) scores for grading opioid withdrawal symptoms. A SOWS total score of 1-10 is considered mild, 11-20 moderate and 21-30 severe. On both scales, greater scores correspond to increased perception of any of the symptoms.
Measured: Baseline through Visit 7 (approximately 45 days) with primary safety assessment after 28 ± 2 days of dosing.
Safety and Tolerability After 28 Days of Use (COWS)
Changes in Clinical Opiate Withdrawal Scale (COWS) scores which is the summed score used to determine the stage or severity of opiate withdrawal and assess the level of physical dependence on opioids (score of below 5 = no withdrawal; 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal).
Measured: Baseline through Visit 7 (approximately 45 days) with primary safety assessment after 28 ± 2 days of dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start5 Feb 2025
- Primary completion22 Oct 2025
- Study completion22 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Onset Muscle Soreness (DOMS)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Traditional Naturals Research Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809282
- Sponsor's protocol ID
- T01-24-01-T0047
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2026
- Last updated
- 9 Sep 2026
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Tolerability of Product Formulations Containing Mitragynine and Their Relative Effects on Exercise-induced Muscle Soreness in Healthy Adult Participants.
- ClinicalTrials.gov ID
- NCT07809282
- Acronym / sponsor ID
- T01-24-01-T0047
- Keywords
- Mitragynine, Delayed Onset Muscle Soreness (DOMS), Exercise-Induced Muscle Soreness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Traditional Naturals Research Inc.Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 22 Oct 2025 (actual)
- First posted
- 9 Sep 2026 (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 Phase II randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, and physical dependence potential of mitragynine-containing formulations after 28 days of use and assess their effects on exercise-induced muscle soreness in healthy adults. One hundred participants will be randomized in a 1:1:1:1 ratio to SpecioTea 20 mg, SpecioTea 40 mg, MitraPlex 20 mg, or placebo. Participants will complete an exercise challenge to induce delayed-onset muscle soreness (DOMS), undergo efficacy assessments at 24 and 48 hours post-exercise, and continue daily dosing for approximately 28 days followed by withdrawal and safety assessments.
Detailed description
This Phase II study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, tolerability, and potential physical dependence associated with two mitragynine-containing formulations (SpecioTea and MitraPlex), while also assessing their efficacy in reducing exercise-induced muscle soreness in healthy adults. Participants will be randomized in a 1:1:1:1 ratio to receive SpecioTea 20 mg, SpecioTea 40 mg, MitraPlex 20 mg, or placebo. The study will enroll approximately 100 healthy adults aged 18 to 55 years who are naïve to kratom use or occasional kratom users and who demonstrate delayed-onset muscle soreness (DOMS) following a screening exercise challenge. Randomization will be stratified by sex.
The study duration for each participant will be approximately 11.5 weeks and will consist of a screening period, an acute efficacy phase, a 28-day supplementation period, and post-treatment follow-up assessments. During screening, participants will complete an exercise challenge designed to induce DOMS. Forty-eight hours later, participants will complete a Visual Analogue Scale (VAS) assessment remotely to confirm the presence of muscle soreness and eligibility for enrollment. Eligible participants will return for the baseline visit at least 27 days after the screening exercise challenge.
At baseline, participants will undergo efficacy and safety assessments, including vital signs, laboratory testing, muscle soreness assessment, strength assessment, range of motion measurements, and evaluations using the Subjective Opiate Withdrawal Scale (SOWS) and Clinical Opiate Withdrawal Scale (COWS). Participants will then receive their assigned study intervention and consume the first dose in clinic. Between 45 and 90 minutes after dosing, participants will complete a standardized exercise challenge intended to induce muscle soreness. Biomarkers of muscle damage, including creatine kinase, lactate dehydrogenase, myoglobin, and creatinine, will be measured before and after exercise. Participants will return approximately 24 and 48 hours after the exercise challenge for additional assessments of muscle soreness, muscle strength, range of motion, and biomarkers of muscle damage.
Following completion of the acute exercise phase, participants will begin once-daily at-home dosing for 28 ± 2 days. Participants assigned to active treatment will receive either SpecioTea or MitraPlex capsules providing 20 mg or 40 mg of mitragynine per day, depending on randomization group. Participants assigned to placebo will receive matching placebo capsules. All participants will consume four capsules daily, and study products will be visually identical to maintain blinding.
The primary objective is to evaluate safety and tolerability after 28 days of continued use. Safety assessments include adverse event monitoring, vital signs, body weight, body mass index, hematology and clinical chemistry laboratory evaluations, and assessments of potential withdrawal symptoms using the SOWS and COWS instruments. Safety laboratory assessments include hematology parameters and clinical chemistry measures such as liver function tests, kidney function markers, electrolytes, glucose, and protein measurements.
Secondary and exploratory objectives are to evaluate the effects of the study interventions on exercise-induced muscle soreness, joint stiffness, muscle strength, and biomarkers of muscle damage. Efficacy outcomes include changes from baseline in VAS scores, knee range of motion, one-repetition maximum (1-RM) strength measures, and serum concentrations of creatine kinase, lactate dehydrogenase, myoglobin, and creatinine following exercise. Assessments will be performed at baseline and at multiple post-exercise timepoints to characterize treatment effects relative to placebo.
After completion of the 28-day dosing period, participants will return for follow-up visits to evaluate safety, collect laboratory data, assess treatment compliance, and monitor for withdrawal symptoms. Follow-up visits will occur the day after the last dose, 2 days later, and 13 days later. These visits will include SOWS and COWS assessments, review of concomitant medications, evaluation of changes in health status, and monitoring for adverse events. The study is intended to provide information regarding the safety profile of mitragynine-containing products and their potential utility in reducing post-exercise muscle soreness in healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SpecioTea 20 mg | Experimental | Dietary Supplement: SpecioTeaParticipants receive 4 capsules daily containing a total of 20 mg mitragynine (2 active capsules plus 2 placebo capsules). |
| SpecioTea 40 mg | Experimental | Dietary Supplement: SpecioTeaParticipants receive 4 active capsules daily containing a total of 40 mg mitragynine. |
| MitraPlex 20 mg | Experimental | Dietary Supplement: MitraPlexParticipants receive 4 active capsules daily containing a total of 20 mg mitragynine. |
| Placebo | Placebo comparator | Other: PlaceboParticipants receive 4 placebo capsules daily. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy males and females who are 18 to 55 years of age (inclusive).
- In good general health as deemed by the investigator and are able to consume the study product.
- Have a BMI between 18.0 to 34.9 kg/m2 (inclusive).
- Naïve to kratom use or occasional kratom use (i.e., have not used kratom more than once within 28 days prior to baseline [Visit 2]).
- Non-smokers (including nicotine vaping) and have not used nicotine-containing products (patches, gums, etc.) for > 3 months prior to baseline (Visit Note: Non-smoker is defined as someone who does not habitually/regularly use products containing nicotine.
Key exclusion criteria (28 listed)
- Individuals who are lactating, planning to become pregnant during the study, or pregnancy as confirmed by a positive urine pregnancy test at screening Visit 1A or Visit 2.
- Have a positive drug screen for any of the compounds listed as confirmed at screening Visit 1A or Visit 2.
- Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients, or the rescue medication, NARCAN® (naloxone).
- Current COVID-19 infections, or currently have the post COVID-19 condition as defined by World Health Organization (WHO) (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis).
- Have exercised regularly (generally > 150 cumulative minutes per week) for 6 months prior to screening (Visit 1A) and/or Visit 2.
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 |
|---|---|---|
| SpecioTeaSpecioTea is a dried aqueous kratom leaf extract administered orally in capsule form. Participants receive 4 capsules once daily. The study evaluates two dosage levels: 20 mg mitragynine daily (2 active capsules plus 2 placebo capsules) and 40 mg mitragynine daily (4 active capsules). | Dietary supplement | SpecioTea 20 mg, SpecioTea 40 mg |
| MitraPlexMitraPlex is a dried ethanolic/water kratom leaf extract administered orally in capsule form. Participants receive 4 active capsules once daily providing a total daily dose of 20 mg mitragynine. | Dietary supplement | MitraPlex 20 mg |
| PlaceboMatching placebo capsules administered orally. Participants receive 4 placebo capsules once daily. Placebo capsules are visually indistinguishable from active study product capsules to maintain blinding. | Other | Placebo |
Primary outcome
Safety and Tolerability After 28 Days of Use (Vitals)
Time frame: Baseline through Visit 7 (approximately 45 days) with primary safety assessment after 28 ± 2 days of dosing.
Heart Rate (bpm)
Safety and Tolerability After 28 Days of Use (Vitals)
Time frame: Baseline through Visit 7 (approximately 45 days) with primary safety assessment after 28 ± 2 days of dosing.
Blood Pressure (mmHg)
To assess the effect of each TP intervention on changes in creatinine compared to each other and to a placebo
Time frame: Change from baseline to 1 hour, 24 hours, and 48 hours post-exercise
Change in concentration of creatinine
To assess the effect of each TP intervention on changes in myoglobin compared to each other and to a placebo
Time frame: Change from baseline to 1 hour, 24 hours, and 48 hours post-exercise
Change in concentration of myoglobin
To assess the effect of each TP intervention on changes in lactose dehydrogenase (LDH) compared to each other and to a placebo
Time frame: Change from baseline to 1 hour, 24 hours, and 48 hours post-exercise
Change in concentration of LDH
To assess the effect of each TP intervention on changes in CK compared to each other and to a placebo
Time frame: Change from baseline to 1 hour, 24 hours, and 48 hours post-exercise
Change in concentration of creatine kinase (CK)
To assess the effect of each TP intervention on muscle strength after intense exercise compared to each other and to a placebo
Time frame: Change from baseline to 24 hours and 48 hours post-exercise
Change in the maximum weight moved
To assess the effect of each TP intervention on reducing joint stiffness after intense exercise compared to each other and to a placebo
Time frame: Change from baseline to 24 hours and 48 hours post-exercise
Change in the magnitude of joint range of motion (degrees)
To assess the efficacy of each TP intervention on reducing exercise-induced muscle soreness at 24 h and 48 h post-exercise compared to each other and to a placebo
Time frame: Change from baseline to 24 hours and to 48 hours post-exercise
Change in Visual Analog Scale score. Participants will draw a vertical line on 100 mm scale that represents the current intensity of their pain where left end of the scale is representative of "no soreness at all" and the right end of the scale is representative of "extreme soreness". The intensity of pain will be considered to be the distance (in mm) of the participant's mark from the left-hand side of the scale.
Safety and Tolerability After 28 Days of Use (Anthropometrics)
Time frame: Baseline through Visit 7 (approximately 45 days) with primary safety assessment after 28 ± 2 days of dosing.
Assessment of Body weight (kg)
Safety and Tolerability After 28 Days of Use (Anthropometrics)
Time frame: Baseline through Visit 7 (approximately 45 days) with primary safety assessment after 28 ± 2 days of dosing.
Assessment of BMI (kg/m2)
Safety and Tolerability After 28 Days of Use (Laboratory Blood Tests)
Time frame: Baseline through Visit 7 (approximately 45 days) with primary safety assessment after 28 ± 2 days of dosing.
Blood samples will be collected to assess hematology parameters (hemoglobin, hematocrit, red blood cell [RBC], red blood cell distribution width [RDW], RBC indices [mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), MCH concentration (MCHC)], white blood cells [WBC] with differential [abs], platelet count, mean platelet volume [MPV]).
Safety and Tolerability After 28 Days of Use (Laboratory Blood Tests)
Time frame: Baseline through Visit 7 (approximately 45 days) with primary safety assessment after 28 ± 2 days of dosing.
Change from baseline in clinical chemistry laboratory parameters. Blood samples will be collected to assess clinical chemistry parameters including urea, creatinine, total bilirubin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), random serum glucose, albumin, globulin, total protein, sodium, potassium, estimated glomerular filtration rate (eGFR), and chloride. Each laboratory parameter will be evaluated and reported separately according to its standard unit of measurement, with change from baseline summarized for each parameter.
Safety and Tolerability After 28 Days of Use (Adverse Events)
Time frame: Baseline through Visit 7 (approximately 45 days) with primary safety assessment after 28 ± 2 days of dosing.
Reports of AEs
Safety and Tolerability After 28 Days of Use (SOWS)
Time frame: Baseline through Visit 7 (approximately 45 days) with primary safety assessment after 28 ± 2 days of dosing.
Changes in Subjective Opiate Withdrawal Scale (SOWS) scores for grading opioid withdrawal symptoms. A SOWS total score of 1-10 is considered mild, 11-20 moderate and 21-30 severe. On both scales, greater scores correspond to increased perception of any of the symptoms.
Safety and Tolerability After 28 Days of Use (COWS)
Time frame: Baseline through Visit 7 (approximately 45 days) with primary safety assessment after 28 ± 2 days of dosing.
Changes in Clinical Opiate Withdrawal Scale (COWS) scores which is the summed score used to determine the stage or severity of opiate withdrawal and assess the level of physical dependence on opioids (score of below 5 = no withdrawal; 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SpecioTea and MitraPlex in people with Delayed Onset Muscle Soreness (DOMS) and Exercise-Induced Muscle Soreness, run by Traditional Naturals Research Inc. at 1 site in Canada.
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 13 inclusion and 28 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: finished, as of the sponsor's last update on 9 Sep 2026. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability After 28 Days of Use (Vitals) (time frame: Baseline through Visit 7 (approximately 45 days) with primary safety assessment after 28 ± 2 days of dosing.). The study lists 16 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 9 Sep 2026.