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

Mitosynergy LLC56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Neuralgia Myalgia

Interventions

CunermuspirDRUG

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

PlaceboOTHER

same non-medical ingredients and encapsulation as Intervention 1

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

KGK Synergize now KGK Science

London, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: baseline and 28 days after enrollment

Platelet ATP

Platelet ATP levels were measured as previously published in the literature.

Time frame: baseline and 28 days after enrollment

Secondary Outcomes

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.

Time frame: 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.

Data from ClinicalTrials.gov

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