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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Platelet ATP
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Cunermuspir (Drug)
Placebo
Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm
干预措施: Placebo (Other)
结局指标
主要结局
Platelet ATP
时间窗: baseline and 28 days after enrollment
Platelet ATP levels were measured as previously published in the literature.
Neuromuscular Symptoms
时间窗: 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.
次要结局
- Diastolic Blood Pressure(baseline and 28 days after enrollment)
- WBC(baseline and 28 days after enrollment)
- MCHC(baseline and 28 days after enrollment)
- Household Chores and Neuro Muscular Sumptoms(baseline and 28 days after enrollment)
- Hemoglobin(baseline and 28 days after enrollment.)
- RDW(baseline and 28 days after enrollment)
- Platelets(baseline and 28 days after enrollment)
- Sodium(baseline and 28 days after enrollment)
- Hematocrit(baseline and 28 days after enrollment)
- Neutrophils(baseline and 28 days after enrollment)
- Glucose(baseline and 28 days after enrollment)
- Potassium(baseline and 28 days after enrollment)
- Heart Rate(baseline and 28 days after enrollment)
- RBC(baseline and 28 days after enrollment)
- MCV(baseline and 28 days after enrollment)
- MCH(baseline and 28 days after enrollment)
- Lymphocyte(baseline and 28 days after enrollment)
- Eosinophil(baseline and 28 days after enrollment)
- Cognition(baseline and 28 days after enrollment)
- Systolic Blood Pressure(baseline and 28 days after enrollment.)
- Monocyte(baseline and 28 days after enrollment)
- Basophil(baseline and 28 days after enrollment)
- Bilirubin(baseline and 28 days after enrollment)
- ALT(baseline and 28 days after enrollment)
- AST(baseline and 28 days after enrollment)
- GGT(baseline and 28 days after enrollment)
- Copper(baseline and 28 days after enrollment)
- NLR(baseline and 28 days after enrollment)
- Urea(baseline and 28 days after enrollment)
- Creatinine(baseline and 28 days after enrollment)
- eGFR(baseline and 28 days after enrollment)
- Chloride(baseline and 28 days after enrollment)