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

Neuralgia Clinical Trial

Official title:

A Randomized, Double Blind, Placebo Controlled, Parallel Study Evaluating the Safety and Efficacy of Cunermuspir on Energy, Strength, Fatigue and Discomfort in Subjects With Nerve or Muscle Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04737278
• Other study ID #: 13MFHM
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 28, 2014
• Est. completion date: September 29, 2014

Study information

• Verified date: March 2021
• Source: Mitosynergy LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 29, 2014
• Est. primary completion date: May 28, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Myalgia
• Neuralgia

Intervention

Drug:
• Cunermuspir
Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide

Other:
• Placebo
same non-medical ingredients and encapsulation as Intervention 1

Locations

Country	Name	City	State
Canada	KGK Synergize now KGK Science	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Mitosynergy LLC

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	baseline and 28 days after enrollment
Primary	Platelet ATP	Platelet ATP levels were measured as previously published in the literature.	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.	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.	baseline and 28 days after enrollment
Secondary	Heart Rate	heart rate is measured in beats per minute	baseline and 28 days after enrollment
Secondary	Diastolic Blood Pressure	The diastolic blood pressure was measured in mm Hg	baseline and 28 days after enrollment
Secondary	Systolic Blood Pressure	Systolic blood pressure was measured in mm Hg	baseline and 28 days after enrollment.
Secondary	Hemoglobin	changes measured in g/L blood	baseline and 28 days after enrollment.
Secondary	Hematocrit	changes in the fraction of whole blood occupied by red blood cells measured as L/L	baseline and 28 days after enrollment
Secondary	WBC	changes in white blood cells (WBC) measured in units of 10^9 per liter blood	baseline and 28 days after enrollment
Secondary	RBC	changes in red blood cells (RBC) measured in units of 10^12 per liter blood	baseline and 28 days after enrollment
Secondary	MCV	changes in mean corpuscular volume (MCV) measured in units of fL	baseline and 28 days after enrollment
Secondary	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
Secondary	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
Secondary	RDW	changes in the RBC distribution width (RDW) are reported in units of percentage (%)	baseline and 28 days after enrollment
Secondary	Platelets	changes in the platelet counts are reported in units of 10^9 per liter blood	baseline and 28 days after enrollment
Secondary	Neutrophils	changes in neutrophils are reported in units of 10^9 per liter blood	baseline and 28 days after enrollment
Secondary	Lymphocyte	changes in lymphocytes are reported in units of 10^9 per liter blood	baseline and 28 days after enrollment
Secondary	Monocyte	changes in monocytes are reported in units of 10^9 per liter blood	baseline and 28 days after enrollment
Secondary	Eosinophil	changes in eosinophils are reported in units of 10^9 cells per liter blood	baseline and 28 days after enrollment
Secondary	Basophil	changes in basophils are reported in units of 10^9 cells per liter blood	baseline and 28 days after enrollment
Secondary	NLR	Changes in the neutrophil to lymphocyte ratio (NLR) are reported as a dimensionless fraction of 1	baseline and 28 days after enrollment
Secondary	Glucose	changes in blood glucose are reported in units of mmol per liter	baseline and 28 days after enrollment
Secondary	Urea	changes in renal function as measured by blood urea are reported in units of mmol per liter	baseline and 28 days after enrollment
Secondary	Creatinine	changes in creatinine are reported in units of micromol per liter	baseline and 28 days after enrollment
Secondary	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
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	baseline and 28 days after enrollment
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	baseline and 28 days after enrollment
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	baseline and 28 days after enrollment
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	baseline and 28 days after enrollment
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	baseline and 28 days after enrollment
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	baseline and 28 days after enrollment
Secondary	GGT	changes in the liver enzyme gamma-glutamyl transferase in the blood are reported as units per liter	baseline and 28 days after enrollment
Secondary	Copper	changes in copper concentration in the blood are reported in units of micro moles per liter	baseline and 28 days after enrollment