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Male and female participants were selected based on chronic neuromuscular pain. Patients were instructed to take two doses of the placebo or cuprous nicotinic acid chelate Cunermusmir twice a day for 28 days. Hypothesis: Cunermuspir would improve quality of life as determined by several questionnaires.
A total of 72 subjects were consented and screened, with 56 subjects (28 males and 28 female) being eligible to participate in the study. Fifty-six subjects with muscle/nerve pain were randomized at a ratio of 1:1 to one of two treatment groups. To evaluate primary and secondary objectives, study assessments were conducted at Baseline, and Day 28 ± 2. The Individualized Neuromuscular Quality of Life Questionnaire (INQoL), Symptom Impact Questionnaire (SQIR), Mini-Mental State Examination (MMSE) were completed by participants to assess physical function, pain, fatigue/energy and cognitive function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cunermuspir | Experimental | Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. |
|
| Placebo | Placebo Comparator | Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cunermuspir | Drug | Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neuromuscular Symptoms | Quality of life was assessed by using the Individualized Neuromuscular Quality of Life Questionnaire (INQoL) Answers to symptom questions are scored from 0 to 6 or 7 with 0 being "none at all" and and 6 to 7 being "an extreme amount" There are three questions regarding pain. The pain score is (a+b+c)/19 x100. The higher the score, the greater the symptom impact. | baseline and 28 days after enrollment |
| Platelet ATP | Platelet ATP levels were measured as previously published in the literature. | baseline and 28 days after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Household Chores and Neuro Muscular Sumptoms | Physical function in performing household chores was assessed using the Revised Symptom Impact Questionnaire (SQIR) For each household chore participants are asked to check 1 of 11 boxes between "no difficulty" and "extremely difficult" No difficulty is scored as 0 and extreme difficulty with the task is scored as 10. The higher the score, the more difficulty experienced performing the chore. Friend & Bennett Arthritis Res & Therapy 2011. Household chores are just one module with 9 questions for a maximum of 90 points. These scores are summed and divided by 3. Module 2 relates to the emotional impact with only two questions for a total of 20 points. Module 3 relates to physical symptoms with a total of ten questions worth a maximum of 100 points. This score is divided by 2. The three modules are summed for a total impact score of 100 points. A score of 0 indicates absolutely no impact and a score of 100 the greatest possible impact. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Synergize now KGK Science | London | Ontario | N6A 5R8 | Canada |
Close collaboration with KGK Synergize/Science will be needed to determine which data can be legally shared. In retrospective analysis of data six years later, raw data in the form of a spreadsheet proved to be extremely valuable.
The data will be shared as soon as Mitosynergy meets the regulatory requirements for sharing.
Access will be determined by regulatory requirements. Mitosynergy favors as broad access as the law allows. If the law permits access on company websites, Mitosynergy will favor this.
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A total of 56 met the enrollment requirements. Of these only 49 completed the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Cunermuspir | Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide |
| FG001 | Placebo | Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cunermuspir | Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Neuromuscular Symptoms | Quality of life was assessed by using the Individualized Neuromuscular Quality of Life Questionnaire (INQoL) Answers to symptom questions are scored from 0 to 6 or 7 with 0 being "none at all" and and 6 to 7 being "an extreme amount" There are three questions regarding pain. The pain score is (a+b+c)/19 x100. The higher the score, the greater the symptom impact. | Three patients were lost to followup.Four other patients had testing issues that the study investigators deemed them to be removed from baseline and day 28 analyses. This is why there are not 28 patients represented in baseline whereas there are in toxicology related outcome measures. | Posted | Mean | Standard Error | score on a scale | baseline and 28 days after enrollment |
|
28 days
All treatment--emergent adverse events (AEs) are listed and MedDRA--coded to obtain the MedDRA Preferred Term and Organ System ("body system"). The nature, incidence, severity and causality were AEs were summarized in a frequency table, by body system and treatment. The proportion of subjects experiencing one or more AEs were compared between groups, separately for each body system and for all AEs combined.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cunermuspir | Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nasea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | also includes upset stomach, dry mouth, and dry mouth |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Barbara Leinweber, PhD | BDL Biochemistry, consultant for Mitosynergy | (520)334-5444 | barb@bdlbiochem.com |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D063806 | Myalgia |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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randomized, double--blind, placebo controlled, parallel study
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The investigational product bottles were labeled according to the requirements of ICH--GCP guidelines and applicable local regulatory guidelines. Investigational products were coded by the unblinded personnel at KGK Synergize who were not involved in the collecting or analyzing of study data. Each package contained a similar label differing only in randomization number.
|
| Placebo | Other | same non-medical ingredients and encapsulation as Intervention 1 |
|
| baseline and 28 days after enrollment |
| Cognition | Cognition is the mental process of knowing, including aspects such as awareness, perception, reasoning, and judgment. The mini-mental state exam (MMSE) puts a number to "cognition." Any score of 24 or more out of a total 30 points is considered normal cognition. A test taker may be asked to orientate in space and time by recalling aspects of the physical location as well as month, day, year, and perhaps season. Simple mathematical calculations like counting backwards from 100 by seven may also be included. A complex command such as redrawing geometric figures scores six points in this exam. Since none of the participates were cognitively impaired, the investigators decided to make obtaining a perfect score on this exam an outcome measure. | baseline and 28 days after enrollment |
| Heart Rate | heart rate is measured in beats per minute | baseline and 28 days after enrollment |
| Diastolic Blood Pressure | The diastolic blood pressure was measured in mm Hg | baseline and 28 days after enrollment |
| Systolic Blood Pressure | Systolic blood pressure was measured in mm Hg | baseline and 28 days after enrollment. |
| Hemoglobin | changes measured in g/L blood | baseline and 28 days after enrollment. |
| Hematocrit | changes in the fraction of whole blood occupied by red blood cells measured as L/L | baseline and 28 days after enrollment |
| WBC | changes in white blood cells (WBC) measured in units of 10^9 per liter blood | baseline and 28 days after enrollment |
| RBC | changes in red blood cells (RBC) measured in units of 10^12 per liter blood | baseline and 28 days after enrollment |
| MCV | changes in mean corpuscular volume (MCV) measured in units of fL | baseline and 28 days after enrollment |
| MCH | changes in mean corpuscular hemoglobin, measured in units of pg, the average amount of hemoglobin in a single RBC | baseline and 28 days after enrollment |
| MCHC | mean corpuscular hemoglobin concentration is the concentration of hemoglobin in a single RBC measured in units of g/L | baseline and 28 days after enrollment |
| RDW | changes in the RBC distribution width (RDW) are reported in units of percentage (%) | baseline and 28 days after enrollment |
| Platelets | changes in the platelet counts are reported in units of 10^9 per liter blood | baseline and 28 days after enrollment |
| Neutrophils | changes in neutrophils are reported in units of 10^9 per liter blood | baseline and 28 days after enrollment |
| Lymphocyte | changes in lymphocytes are reported in units of 10^9 per liter blood | baseline and 28 days after enrollment |
| Monocyte | changes in monocytes are reported in units of 10^9 per liter blood | baseline and 28 days after enrollment |
| Eosinophil | changes in eosinophils are reported in units of 10^9 cells per liter blood | baseline and 28 days after enrollment |
| Basophil | changes in basophils are reported in units of 10^9 cells per liter blood | baseline and 28 days after enrollment |
| NLR | Changes in the neutrophil to lymphocyte ratio (NLR) are reported as a dimensionless fraction of 1 | baseline and 28 days after enrollment |
| Glucose | changes in blood glucose are reported in units of mmol per liter | baseline and 28 days after enrollment |
| Urea | changes in renal function as measured by blood urea are reported in units of mmol per liter | baseline and 28 days after enrollment |
| Creatinine | changes in creatinine are reported in units of micromol per liter | baseline and 28 days after enrollment |
| eGFR | changes in the estimated glomerular filtration rate (eGFR) are reported in units of mL/min/1.73m^2 | baseline and 28 days after enrollment |
| Sodium | changes in plasma sodium are reported in units of mmol per liter, reference range is 133-146 mEq/L, same as mM/L bloodbook.com | baseline and 28 days after enrollment |
| Potassium | changes in plasma potassium are reported in units of mmol per liter, reference value 3.5-5.4 mmol per liter, bloodbook.com | baseline and 28 days after enrollment |
| Chloride | changes in plasma chloride are reported in uits of mmol per liter The reference range is 98-106 mmol per liter, bloodbook.com | baseline and 28 days after enrollment |
| Bilirubin | changes in total bilirubin are reported in units of micro moles per liter. Direct: up to 0.4 mg/dL, Total: up to 1.0 mg/dL bloodbook.com, Converts to 6.84-17.1 micro moles per liter. https://unitslab.com/node/37 | baseline and 28 days after enrollment |
| ALT | changes in the liver enzyme alanine aminotransferase (ALT) in the blood are reported as units per liter Reference range 1 - 21 units/L bloodbook.com | baseline and 28 days after enrollment |
| AST | changes in the liver enzyme aspartate aminotransferase (AST) in the blood are reported as units per liter Reference range 7 - 27 units/L bloodbook.com | baseline and 28 days after enrollment |
| GGT | changes in the liver enzyme gamma-glutamyl transferase in the blood are reported as units per liter | baseline and 28 days after enrollment |
| Copper | changes in copper concentration in the blood are reported in units of micro moles per liter | baseline and 28 days after enrollment |
| Protocol Violation |
|
| failure to complete questionnaire |
|
| BG001 | Placebo | Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1 |
|
|
|
| Primary | Platelet ATP | Platelet ATP levels were measured as previously published in the literature. | ATP isolated from platelets. Some samples were not used for analysis due to contamination with red blood cells. | Posted | Mean | Standard Deviation | nmol / E9 Platelets | baseline and 28 days after enrollment |
|
|
|
|
| Secondary | Household Chores and Neuro Muscular Sumptoms | Physical function in performing household chores was assessed using the Revised Symptom Impact Questionnaire (SQIR) For each household chore participants are asked to check 1 of 11 boxes between "no difficulty" and "extremely difficult" No difficulty is scored as 0 and extreme difficulty with the task is scored as 10. The higher the score, the more difficulty experienced performing the chore. Friend & Bennett Arthritis Res & Therapy 2011. Household chores are just one module with 9 questions for a maximum of 90 points. These scores are summed and divided by 3. Module 2 relates to the emotional impact with only two questions for a total of 20 points. Module 3 relates to physical symptoms with a total of ten questions worth a maximum of 100 points. This score is divided by 2. The three modules are summed for a total impact score of 100 points. A score of 0 indicates absolutely no impact and a score of 100 the greatest possible impact. | Three patients were lost to followup.Four other patients had testing issues that the study investigators deemed them to be removed from baseline and day 28 analyses. This is why there are not 28 patients represented in baseline whereas there are in toxicology related outcome measures. | Posted | Mean | Standard Error | units on a scale | baseline and 28 days after enrollment |
|
|
|
|
| Secondary | Cognition | Cognition is the mental process of knowing, including aspects such as awareness, perception, reasoning, and judgment. The mini-mental state exam (MMSE) puts a number to "cognition." Any score of 24 or more out of a total 30 points is considered normal cognition. A test taker may be asked to orientate in space and time by recalling aspects of the physical location as well as month, day, year, and perhaps season. Simple mathematical calculations like counting backwards from 100 by seven may also be included. A complex command such as redrawing geometric figures scores six points in this exam. Since none of the participates were cognitively impaired, the investigators decided to make obtaining a perfect score on this exam an outcome measure. | Three patients were lost to followup.Four other patients had testing issues that the study investigators deemed them to be removed from baseline and day 28 analyses. This is why there are not 28 patients represented in baseline whereas there are in toxicology related outcome measures. | Posted | Number | participants with perfect score | baseline and 28 days after enrollment |
|
|
|
|
| Secondary | Heart Rate | heart rate is measured in beats per minute | For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures | Posted | Mean | Standard Error | beats per minute | baseline and 28 days after enrollment |
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|
| Secondary | Diastolic Blood Pressure | The diastolic blood pressure was measured in mm Hg | For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures | Posted | Mean | Standard Error | mm Hg | baseline and 28 days after enrollment |
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|
| Secondary | Systolic Blood Pressure | Systolic blood pressure was measured in mm Hg | For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures | Posted | Mean | Standard Error | mm Hg | baseline and 28 days after enrollment. |
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| Secondary | Hemoglobin | changes measured in g/L blood | For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures | Posted | Mean | Standard Error | g/L | baseline and 28 days after enrollment. |
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| Secondary | Hematocrit | changes in the fraction of whole blood occupied by red blood cells measured as L/L | Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures | Posted | Mean | Standard Error | L/L | baseline and 28 days after enrollment |
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| Secondary | WBC | changes in white blood cells (WBC) measured in units of 10^9 per liter blood | Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures | Posted | Mean | Standard Error | 10^9 cells/L | baseline and 28 days after enrollment |
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| Secondary | RBC | changes in red blood cells (RBC) measured in units of 10^12 per liter blood | Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures | Posted | Mean | Standard Error | 10^12 cells/L | baseline and 28 days after enrollment |
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| Secondary | MCV | changes in mean corpuscular volume (MCV) measured in units of fL | Three patients were lost to followup.Four other patients had testing issues that the study investigators deemed them to be removed from baseline and day 28 analyses. This is why there are not 28 patients represented in baseline whereas there are in toxicology related outcome measures. | Posted | Mean | Standard Error | fempto liter per cell | baseline and 28 days after enrollment |
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| Secondary | MCH | changes in mean corpuscular hemoglobin, measured in units of pg, the average amount of hemoglobin in a single RBC | Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures | Posted | Mean | Standard Error | pg per cell | baseline and 28 days after enrollment |
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| Secondary | MCHC | mean corpuscular hemoglobin concentration is the concentration of hemoglobin in a single RBC measured in units of g/L | Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures | Posted | Mean | Standard Error | g/L | baseline and 28 days after enrollment |
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| Secondary | RDW | changes in the RBC distribution width (RDW) are reported in units of percentage (%) | Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures | Posted | Mean | Standard Error | red cell distribution width % | baseline and 28 days after enrollment |
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| Secondary | Platelets | changes in the platelet counts are reported in units of 10^9 per liter blood | By day 28 three participants were lost to followup: two in the Cunermuspir group and one in the placebo group. There were issues in handling of one platelet sample in the Cunermuspir group. This brings the number in the Cunermuspir group down to 25 on day 28. For technical reasons, platelet data are missing for subject 021. All other blood cell data are present in this report of data. | Posted | Mean | Standard Error | 10^9 platelets/L | baseline and 28 days after enrollment |
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| Secondary | Neutrophils | changes in neutrophils are reported in units of 10^9 per liter blood | Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures | Posted | Mean | Standard Error | 10^9 cells/L | baseline and 28 days after enrollment |
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| Secondary | Lymphocyte | changes in lymphocytes are reported in units of 10^9 per liter blood | Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures | Posted | Mean | Standard Error | 10^9 cells/L | baseline and 28 days after enrollment |
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| Secondary | Monocyte | changes in monocytes are reported in units of 10^9 per liter blood | Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures | Posted | Mean | Standard Error | 10^9 cells/L | baseline and 28 days after enrollment |
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| Secondary | Eosinophil | changes in eosinophils are reported in units of 10^9 cells per liter blood | Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures | Posted | Mean | Standard Error | 10^9 cells/L | baseline and 28 days after enrollment |
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| Secondary | Basophil | changes in basophils are reported in units of 10^9 cells per liter blood | Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures | Posted | Mean | Standard Error | 10^9 cells/L | baseline and 28 days after enrollment |
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| Secondary | NLR | Changes in the neutrophil to lymphocyte ratio (NLR) are reported as a dimensionless fraction of 1 | Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures | Posted | Mean | Standard Error | dimensionaless units | baseline and 28 days after enrollment |
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| Secondary | Glucose | changes in blood glucose are reported in units of mmol per liter | In this population the initial screening was considered the baseline for all blood chemistry parameters. Three of the the participants were lost to followup or withdrew from the study | Posted | Mean | Standard Error | mmol/L | baseline and 28 days after enrollment |
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| Secondary | Urea | changes in renal function as measured by blood urea are reported in units of mmol per liter | Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures | Posted | Mean | Standard Error | mmol/L | baseline and 28 days after enrollment |
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| Secondary | Creatinine | changes in creatinine are reported in units of micromol per liter | Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures | Posted | Mean | Standard Error | micromol/L | baseline and 28 days after enrollment |
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| Secondary | eGFR | changes in the estimated glomerular filtration rate (eGFR) are reported in units of mL/min/1.73m^2 | Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures | Posted | Mean | Standard Error | mL/min/1.73 m^2 | baseline and 28 days after enrollment |
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| Secondary | Sodium | changes in plasma sodium are reported in units of mmol per liter, reference range is 133-146 mEq/L, same as mM/L bloodbook.com | Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures | Posted | Mean | Standard Error | mmol/L | baseline and 28 days after enrollment |
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| Secondary | Potassium | changes in plasma potassium are reported in units of mmol per liter, reference value 3.5-5.4 mmol per liter, bloodbook.com | The study sponsor is of the opinion that these participants were dehydrated when they started the study. They were instructed to drink more water. Three of the 56 that started the study were lost to followup or withdrew. | Posted | Mean | Standard Error | mmol/L | baseline and 28 days after enrollment |
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| Secondary | Chloride | changes in plasma chloride are reported in uits of mmol per liter The reference range is 98-106 mmol per liter, bloodbook.com | Enrollment pre-screening values are taken as the baseline. The study sponsor was of the opinion that these participants started the study dehydrated. Of the original 56 three were lost to followup or withdrew. | Posted | Mean | Standard Error | mmol/L | baseline and 28 days after enrollment |
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| Secondary | Bilirubin | changes in total bilirubin are reported in units of micro moles per liter. Direct: up to 0.4 mg/dL, Total: up to 1.0 mg/dL bloodbook.com, Converts to 6.84-17.1 micro moles per liter. https://unitslab.com/node/37 | Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures | Posted | Mean | Standard Error | micromol/L | baseline and 28 days after enrollment |
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| Secondary | ALT | changes in the liver enzyme alanine aminotransferase (ALT) in the blood are reported as units per liter Reference range 1 - 21 units/L bloodbook.com | Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures | Posted | Mean | Standard Error | U/L | baseline and 28 days after enrollment |
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| Secondary | AST | changes in the liver enzyme aspartate aminotransferase (AST) in the blood are reported as units per liter Reference range 7 - 27 units/L bloodbook.com | Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures | Posted | Mean | Standard Error | U/L | baseline and 28 days after enrollment |
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| Secondary | GGT | changes in the liver enzyme gamma-glutamyl transferase in the blood are reported as units per liter | Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures | Posted | Mean | Standard Error | U/L | baseline and 28 days after enrollment |
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| Secondary | Copper | changes in copper concentration in the blood are reported in units of micro moles per liter | Of the 56 enrolled in the study three were lost to followup or dropped out. | Posted | Mean | Standard Error | U/L | baseline and 28 days after enrollment |
|
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 6 |
| 26 |
| EG001 | Placebo | Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1 | 0 | 28 | 0 | 28 | 7 | 27 |
|
| seasonal respiratory infections | Infections and infestations | MedDRA (10.0) | Systematic Assessment | includes sinusitis, common cold, and flu |
|
| moderate dermatitis | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| head ache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment | the study investigators concluded that on of the two head ache in the Cunermuspir Arm may have been related to the study product. |
|
The study PI (Dale Wilson) retired soon after the study was completed. KGK Synergize has undergone reorganization as KGK Science. The original intent was to publish the study results in a peer review journal.
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D059352 | Musculoskeletal Pain |
| Other |
| comparison made at day 28 | Wilcoxon (Mann-Whitney) | 0.01 | Other |
| comparison between baseline and day 28 | t-test, 2 sided | 0.07 | Other |
| Other |
| day 28 |
|
|
| day 28 |
|
|
| day 28 |
|
|
| day 28 |
|
|
| day 28 |
|
|
| day 28 |
|
|
| day 28 |
|
|
| day 28 |
|
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| day 28 |
|
|
| day 28 |
|
|
| day 28 |
|
|
| day 28 |
|
|
| day 28 |
|
|
| Other |
| day 28 |
|
|
| day 28 |
|
|
| 0.24 |
| Other |
| day 28 |
|
|
| day 28 |
|
|
| day 28 |
|
|
| day 28 |
|
|
| 0.04 |
| Other |
| ANCOVA | 0.92 | Other |
| day 28 |
|
|
| day 28 |
|
|
| day 28 |
|
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| day 28 |
|
|
| Other |
| Blood sodium concentration between baseline and day 28 in the Placebo group. | t-test, 2 sided | 0.01 | Other |
| day 28 |
|
|
| Other |
| comparison of blood potassium concentrations from enrollment to day 28 in participants in the Placebo arm. | t-test, 2 sided | <0.001 | Other |
| day 28 |
|
|
| Other |
| comparison of blood chloride concentrations between baseline and day 28 in Placebo Arm participants | t-test, 2 sided | 0.003 | Other |
| day 28 |
|
|
Wilcoxon Signed-Rank |
| 0.72 |
| Other |
| bilirubin concentrations compared between baseline and Day 28 in the Placebo Arm | Wilcoxon (Mann-Whitney) | 0.35 | Other |
| day 28 |
|
|
| Other |
| comparison between baseline and day 28 values for the Placebo Arm | Wilcoxon (Mann-Whitney) | 0.8 | Other |
| day 28 |
|
|
| 0.24 |
| Other |
| baseline to day 28 comparison of AST activity in Placebo group | Wilcoxon (Mann-Whitney) | 0.11 | Other |
| day 28 |
|
|
| Wilcoxon Signed Rank |
| 0.01 |
| Other |
| Comparison of GGT activity in blood between Placebo Arm participants at baseline and on day 28 | Wilcoxon Signed-Rank | 0.97 | Other |
| day 28 |
|
|
| 0.10 |
| Other |
| comparison between baseline and day 28 serum copper concentrations in the Placebo Arm | t-test, 2 sided | 0.89 | Other |