Safety and Efficacy of Cunermuspir on Energy, Strength, and Fatigue in Patients With Nerve or Muscle Pain

Phase 1

Completed

Conditions: Neuralgia
Myalgia

Interventions: Drug: Cunermuspir
Other: Placebo

Registration Number: NCT04737278

Lead Sponsor: Mitosynergy LLC

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 56

Inclusion Criteria

Male or female age 18-75
If female, subject is not of child bearing potential. Defined as females who have
had a hysterectomy or oophorectomy.
bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation).
Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include: Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo--Provera, Lunelle), or hormone implant (Norplant System), Intrauterine devices, Vasectomy of partner, Total Abstinence
Subject has unresolved persistent muscle or nerve pain (muscle or nerve pain population)
Subjects using other therapies for nerve/muscle pain (e.g., exercise, TENS, acupuncture, exercise, psychotherapy, massage, physiotherapy, etc), must be used at a stable schedule for 1 month prior to the trial and subject agrees to continue these therapies at the same schedule during the trial avoiding changes in frequency or intensity and to record therapies in the study diary
Agrees to comply with study procedures
Has given voluntary, written, informed consent to participate in
the study

Exclusion Criteria

Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
Planned surgery during the course of the trial
Use of prescription drugs for fibromyalgia or nerve pain (e.g.Lyrica, Cymbalta and Savella and others).
Use of prescription medications for depression, anxiety or other mental disorders
Requires the use of prescription drugs to control pain (other than provided rescue medication)
Use of oral or topical prescription or over the counter medications or natural health products for pain relief 3 days prior to randomization and during the trial (other than provided rescue medication)
Use of natural health products including vitamins and minerals within 3 days prior to randomization and during the trial
Use of blood thinning medications (e.g. warfarin)
Chronic lyme disease or chronic parasitic infections
Uncontrolled hypertension defined as untreated systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg
Subjects with diabetes
History of bleeding disorders, or significant blood loss in the past 3 months
Alcohol use >2 standard alcoholic drinks per day and/or alcohol or drug abuse within the past year
Allergy or sensitivity to study supplement ingredients or acetaminophen
Participation in a clinical research trial within 30 days prior to randomization
Individuals who are cognitively impaired and/or who are unable to give informed consent
Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cunermuspir	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.
Placebo	Placebo	Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Primary Outcome Measures

Name	Time	Method
Platelet ATP	baseline and 28 days after enrollment	Platelet ATP levels were measured as previously published in the literature.
Neuromuscular Symptoms	baseline and 28 days after enrollment	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.

Secondary Outcome Measures

Name	Time	Method
MCH	baseline and 28 days after enrollment	changes in mean corpuscular hemoglobin, measured in units of pg, the average amount of hemoglobin in a single RBC
Diastolic Blood Pressure	baseline and 28 days after enrollment	The diastolic blood pressure was measured in mm Hg
WBC	baseline and 28 days after enrollment	changes in white blood cells (WBC) measured in units of 10\^9 per liter blood
MCHC	baseline and 28 days after enrollment	mean corpuscular hemoglobin concentration is the concentration of hemoglobin in a single RBC measured in units of g/L
Household Chores and Neuro Muscular Sumptoms	baseline and 28 days after enrollment	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.
Hemoglobin	baseline and 28 days after enrollment.	changes measured in g/L blood
RDW	baseline and 28 days after enrollment	changes in the RBC distribution width (RDW) are reported in units of percentage (%)
Platelets	baseline and 28 days after enrollment	changes in the platelet counts are reported in units of 10\^9 per liter blood
Sodium	baseline and 28 days after enrollment	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
Hematocrit	baseline and 28 days after enrollment	changes in the fraction of whole blood occupied by red blood cells measured as L/L
Neutrophils	baseline and 28 days after enrollment	changes in neutrophils are reported in units of 10\^9 per liter blood
Glucose	baseline and 28 days after enrollment	changes in blood glucose are reported in units of mmol per liter
Potassium	baseline and 28 days after enrollment	changes in plasma potassium are reported in units of mmol per liter, reference value 3.5-5.4 mmol per liter, bloodbook.com
Heart Rate	baseline and 28 days after enrollment	heart rate is measured in beats per minute
RBC	baseline and 28 days after enrollment	changes in red blood cells (RBC) measured in units of 10\^12 per liter blood
MCV	baseline and 28 days after enrollment	changes in mean corpuscular volume (MCV) measured in units of fL
Lymphocyte	baseline and 28 days after enrollment	changes in lymphocytes are reported in units of 10\^9 per liter blood
Eosinophil	baseline and 28 days after enrollment	changes in eosinophils are reported in units of 10\^9 cells per liter blood
Cognition	baseline and 28 days after enrollment	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.
Systolic Blood Pressure	baseline and 28 days after enrollment.	Systolic blood pressure was measured in mm Hg
Monocyte	baseline and 28 days after enrollment	changes in monocytes are reported in units of 10\^9 per liter blood
Basophil	baseline and 28 days after enrollment	changes in basophils are reported in units of 10\^9 cells per liter blood
Bilirubin	baseline and 28 days after enrollment	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
ALT	baseline and 28 days after enrollment	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
AST	baseline and 28 days after enrollment	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
GGT	baseline and 28 days after enrollment	changes in the liver enzyme gamma-glutamyl transferase in the blood are reported as units per liter
Copper	baseline and 28 days after enrollment	changes in copper concentration in the blood are reported in units of micro moles per liter
NLR	baseline and 28 days after enrollment	Changes in the neutrophil to lymphocyte ratio (NLR) are reported as a dimensionless fraction of 1
Urea	baseline and 28 days after enrollment	changes in renal function as measured by blood urea are reported in units of mmol per liter
Creatinine	baseline and 28 days after enrollment	changes in creatinine are reported in units of micromol per liter
eGFR	baseline and 28 days after enrollment	changes in the estimated glomerular filtration rate (eGFR) are reported in units of mL/min/1.73m\^2
Chloride	baseline and 28 days after enrollment	changes in plasma chloride are reported in uits of mmol per liter The reference range is 98-106 mmol per liter, bloodbook.com