A Randomized, Double-blind, Placebo-controlled, Cross-over, Pilot Study to Investigate the Efficacy of Pain Bloc-R in Healthy Participants With Non-pathological Aches and Discomfort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Comparison of change in unresolved aches and discomfort from pre-supplementation to Day 7 between Pain Bloc-R, comparator and placebo as assessed by the Brief Pain Inventory (BPI) questionnaire
研究概览
简要总结
A randomized, double-blind, placebo-controlled, cross-over pilot study to investigate the efficacy of Pain Bloc-R in healthy participants with non-pathological aches and discomfort. The study will have 3 study periods. During each study period, eligible participants will consume either Pain Bloc-R, comparator product, or placebo for 7 days during each study period (1 product per study period), with a 1-week washout period in between each period. The primary objective is the comparison of change in unresolved aches and discomfort from pre-supplement to Day 7 between the Pain Bloc-R, comparator, and placebo, as assessed by the Brief Pain Inventory (BPI) questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All products look identical in identical opaque capsules
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 18-65 years of age, inclusive
- •BMI of 18-32.5 kg/m2, inclusive
- •Individuals with occupational (construction workers, manual labourers, athletes) and non-occupational unresolved aches and discomfort for at least 2 weeks
- •Individuals on non-prescription, OTC medication for unresolved aches and discomfort and are willing to undergo a washout determined by the QI based on dose and frequency prior to enrollment
- •Female participants not of child bearing potential, defined as females who have had a hysterectomy or bilateral oophorectomy, bilateral tubal ligation, total endometrial ablation or are post-menopausal (natural or surgically with > 1 year since last menstruation) or, Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. All hormonal birth control must have been in use for a minimum of three months. 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)
- •Double-barrier method
- •Intrauterine devices
- •Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- •Vasectomy of partner at least 6 months prior to screening
- •Healthy as determined by laboratory results and medical history as assessed by the QI
- •Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
- •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 trial
- •Anticipated problems or allergy to any ingredients in the investigational products
- •Allergy to rescue medication
- •Have chronic disease conditions causing chronic pain
- •Uncontrolled high and low blood pressure
- •Uncontrolled blood sugar levels
- •Clinically significant abnormal laboratory results at screening
- •Prescribed medications used to help with aches and discomfort (Section 7.3.1)
- •OTC medications and supplements taken to help with aches and discomfort (Section 7.3.2)
- •Autoimmune disease or if immune-compromised (i.e. HIV-positive, use of anti-rejection medication, rheumatoid arthritis, Hepatitis B/C-positive)
- •Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow-up that is negative. Volunteers with cancer in full remission for more than 5 years after diagnosis are acceptable after review by QI
- •History of mental illness that might impair the ability of participants to provide written informed consent
- •Current or history of bleeding disorders
- •Current or history of liver or kidney disease as assessed by QI on a case by case basis.
- •Current or pre-existing unstable thyroid condition. Treatment on a stable dose medication for over one year will be reviewed on a case-by-base basis by the QI
- •Surgical procedures which may impact the study outcomes within the past 3 months to be assessed by the QI
- •Medicinal marijuana
- •Recreational marijuana; dose and frequency to be assessed by QI
- •Alcohol intake >2 standard drinks per day or >10 standard drinks per week
- •Illicit drug use in the past 6 months as assessed by the QI
- •Participation in clinical trials within 30 days prior to screening visit
- •Blood donation during or within 30 days after conclusion of clinical trial
- •Any other active or unstable medical condition, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant.
研究组 & 干预措施
Randomized to consume Pain Bloc-R, Acetaminophen, then placebo
Each study product will be consumed as 2 capsules daily for 7 days. Randomized to consume Investigational Natural Health Product in Study Period 1, Comparator in Study Period 2, and Placebo in Study Period 3.
干预措施: Pain Bloc-R (Dietary Supplement)
Randomized to consume Pain Bloc-R, Acetaminophen, then placebo
Each study product will be consumed as 2 capsules daily for 7 days. Randomized to consume Investigational Natural Health Product in Study Period 1, Comparator in Study Period 2, and Placebo in Study Period 3.
干预措施: Active Comparator - Acetaminophen (Other)
Randomized to consume Pain Bloc-R, Acetaminophen, then placebo
Each study product will be consumed as 2 capsules daily for 7 days. Randomized to consume Investigational Natural Health Product in Study Period 1, Comparator in Study Period 2, and Placebo in Study Period 3.
干预措施: Placebo (Other)
Randomized to consume Acetaminophen, Placebo, then Pain Bloc-R
Each study product will be consumed as 2 capsules daily for 7 days. Randomized to consume Comparator in Study Period 1, Placebo in Study Period 2, and the Investigational Product in Study Period 3.
干预措施: Pain Bloc-R (Dietary Supplement)
Randomized to consume Acetaminophen, Placebo, then Pain Bloc-R
Each study product will be consumed as 2 capsules daily for 7 days. Randomized to consume Comparator in Study Period 1, Placebo in Study Period 2, and the Investigational Product in Study Period 3.
干预措施: Active Comparator - Acetaminophen (Other)
Randomized to consume Acetaminophen, Placebo, then Pain Bloc-R
Each study product will be consumed as 2 capsules daily for 7 days. Randomized to consume Comparator in Study Period 1, Placebo in Study Period 2, and the Investigational Product in Study Period 3.
干预措施: Placebo (Other)
Randomized to consume Placebo, Pain Bloc-R, then Acetaminophen
Each study product will be consumed as 2 capsules daily for 7 days. Randomized to consume Placebo in Study Period 1, Investigational Product in Study Period 2, and Comparator in Study Period 3.
干预措施: Pain Bloc-R (Dietary Supplement)
Randomized to consume Placebo, Pain Bloc-R, then Acetaminophen
Each study product will be consumed as 2 capsules daily for 7 days. Randomized to consume Placebo in Study Period 1, Investigational Product in Study Period 2, and Comparator in Study Period 3.
干预措施: Active Comparator - Acetaminophen (Other)
Randomized to consume Placebo, Pain Bloc-R, then Acetaminophen
Each study product will be consumed as 2 capsules daily for 7 days. Randomized to consume Placebo in Study Period 1, Investigational Product in Study Period 2, and Comparator in Study Period 3.
干预措施: Placebo (Other)
结局指标
主要结局
Comparison of change in unresolved aches and discomfort from pre-supplementation to Day 7 between Pain Bloc-R, comparator and placebo as assessed by the Brief Pain Inventory (BPI) questionnaire
时间窗: 7 days
The Brief Pain Inventory (BPI) questionnaire developed by MD Anderson Cancer Centre is a discomfort assessment tool used to score an individual's level of discomfort severity and discomfort interference. Part A of the questionnaire evaluates pain severity, asking the participants to rate their "worst", "least", "average" and "right now" (current) levels of pain on a scale of 0 (no pain) to 10 (as bad as you can imagine). Part B evaluates the pain interference levels, asking the participants to rate the impact of their pain on their general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. Together, part A and part B aim to serve as a concise quantification tool for the pain levels and the participant's resulting quality of life. The questionnaire will be administered at each visit to monitor changes in participant's pain over the course of each phase.
次要结局
- Comparison between Pain Bloc-R formula, comparator, and placebo in the change in general discomfort from pre-supplementation to Day 7 post-supplementation as assessed by the BPI questionnaire(7 days)
- Comparison between Pain Bloc-R formula, comparator, and placebo in the proportion of participants consuming rescue medicine when taking Pain Bloc-R, comparator, or placebo(7 days)
- Comparison between Pain Bloc-R formula, comparator, and placebo in Product perception and tolerability as assessed by the product perception questionnaire(7 days)
- Comparison between Pain Bloc-R formula, comparator, and placebo in the change in musculoskeletal discomfort (MD) from pre-supplementation to Day 7 post-supplementation as assessed by modified Cornell musculoskeletal discomfort questionnaire(7 days)