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

NCT ID: NCT04737278

Last Updated: 2021-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-28
• Study Completion Date: 2014-09-29

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.

Conditions

Neuralgia; Myalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cunermuspir

Intervention Type: DRUG

Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Placebo

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

same non-medical ingredients and encapsulation as Intervention 1

Interventions

Cunermuspir

Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Intervention Type: DRUG

Placebo

same non-medical ingredients and encapsulation as Intervention 1

Intervention Type: OTHER

Other Intervention Names

cuprous nicotinic acid

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mitosynergy LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

KGK Synergize now KGK Science

London, Ontario, Canada

Countries

Canada

Other Identifiers

13MFHM

Identifier Type: -

Identifier Source: org_study_id