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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized to consume Pain Bloc-R, Acetaminophen, then placebo | Experimental | 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. |
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| Randomized to consume Acetaminophen, Placebo, then Pain Bloc-R | Experimental | 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. |
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| Randomized to consume Placebo, Pain Bloc-R, then Acetaminophen | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain Bloc-R | Dietary Supplement | Herbal Supplement containing Vit D3, Vit B6, Vit B12, White Willow Bark, Angelica Root, Acetyl L-carnitine HCl, Caffeine, L-Theanine, Benfotiamine, and L-Tetrahydropalmatine |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The modified Cornell Musculoskeletal Discomfort Questionnaire (mCMDQ) tool is used to assess physical discomfort. The questionnaire includes a list of body parts with an image for visualization. The questionnaire assesses the discomfort frequency score, from "never" (Rating Score = 0), "1-2 times/week" (RS 1.5), "3-4 times/week" (RS 3.5), "every day" (RS 5) and "several times a day" (RS 10). The questionnaire assesses discomfort severity score, as "slightly uncomfortable" (RS 1), "moderately uncomfortable" (RS = 2) or "very uncomfortable" (RS 3). Finally, the questionnaire determines the discomfort interference score, as "not at all" (RS 1), "slightly interfered" (RS 2), or "interfered a lot" (RS 3). The total discomfort score is calculated by multiplying the individual frequency, severity and interference scores for each body part, and then summed to yield a total discomfort score. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of pre- and post-emergent adverse events (AEs) in the Pain Bloc-R formula, comparator, and placebo groups from pre-supplementation to Day 7 | 7 days | |
| The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on systolic blood pressure from pre-supplementation to Day 7 post-supplementation |
Inclusion Criteria:
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:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Crowley, MD | Qualified Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science Inc. | London | Ontario | N6A 5R8 | Canada |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Randomized, double-blind, placebo-controlled, cross-over
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All products look identical in identical opaque capsules
| Active Comparator - Acetaminophen | Other | DIN 02447479 Encapsulated for Blinding Purposes |
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| Placebo | Other | No active ingredients |
|
| 7 days |
| 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 | 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. | 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 | A questionnaire containing 7 questions regarding the participants satisfaction, tolerability, and feelings toward the study product. The product perception questionnaire will be scored from 5,4,3,2,1 for strongly agree, agree, no opinion, disagree, strongly disagree respectively on each question. Min and max scores for each question are 1 and 5. The total score of the 7 questions is the sum scores of each question with the min and max of 1 and 35. The higher score indicates better product perception for each question and total score. | 7 days |
| 7 days |
| The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on diastolic blood pressure from pre-supplementation to Day 7 post-supplementation | 7 days |
| The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on heart rate from pre-supplementation to Day 7 post-supplementation | 7 days |
| The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on weight from pre-supplementation to Day 7 post-supplementation | 7 days |
| The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on body mass index (BMI) from pre-supplementation to Day 7 post-supplementation | Weight and Height are measured. BMI is calculated by kg/m2. | 7 days |
| The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on clinical chemistry from screening to end-of-study as assessed by alanine aminotransferase (ALT) levels in the blood | Between 42-87 days |
| The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on clinical chemistry from screening to end-of-study as assessed by aspartate aminotransferase (AST) levels in the blood | Between 42-87 days |
| The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on clinical chemistry from screening to end-of-study as assessed by bilirubin levels in the blood | Between 42-87 days |
| The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on clinical chemistry from screening to end-of-study as assessed by creatinine levels in the blood | Between 42-87 days |
| The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on clinical chemistry from screening to end-of-study as assessed by sodium levels in the blood | Between 42-87 days |
| The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on clinical chemistry from screening to end-of-study as assessed by potassium levels in the blood | Between 42-87 days |
| The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on clinical chemistry from screening to end-of-study as assessed by chloride levels in the blood | Between 42-87 days |
| The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on hematology from screening to end-of-study as assessed by hemoglobin | Between 42-87 days |
| The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on hematology from screening to end-of-study as assessed by hematocrit | Between 42-87 days |
| The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on hematology from screening to end-of-study as assessed by platelet count | Between 42-87 days |
| The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on hematology from screening to end-of-study as assessed by red blood cell (RBC) count | Between 42-87 days |
| The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on hematology from screening to end-of-study as assessed by red blood cell (RBC) indices | Between 42-87 days |
| The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on hematology from screening to end-of-study as assessed by red cell distribution width (RDW) | Between 42-87 days |
| The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on hematology from screening to end-of-study as assessed by white blood cell (WBC) count | Between 42-87 days |
| The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on hematology from screening to end-of-study as assessed by neutrophils | Between 42-87 days |
| The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on hematology from screening to end-of-study as assessed by lymphocytes | Between 42-87 days |
| The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on hematology from screening to end-of-study as assessed by monocytes | Between 42-87 days |
| The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on hematology from screening to end-of-study as assessed by eosinophils | Between 42-87 days |
| The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on hematology from screening to end-of-study as assessed by basophils | Between 42-87 days |