Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Investigate the Efficacy of Pain Bloc-R in Healthy Participants With Non-pathological Aches and Discomfort

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03965819
Recruitment Status : Completed
First Posted : May 29, 2019
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
KGK Science Inc.
Information provided by (Responsible Party):
LifeSeasons Inc.

Tracking Information
First Submitted Date  ICMJE May 24, 2019
First Posted Date  ICMJE May 29, 2019
Last Update Posted Date August 13, 2019
Actual Study Start Date  ICMJE May 30, 2019
Actual Primary Completion Date August 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
  • 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 [ Time Frame: 7 days ]
    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.
  • 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 [ Time Frame: 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.
  • 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 [ Time Frame: 7 days ]
  • Comparison between Pain Bloc-R formula, comparator, and placebo in Product perception and tolerability as assessed by the product perception questionnaire [ Time Frame: 7 days ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
  • 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 [ Time Frame: 7 days ]
    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.
  • 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 [ Time Frame: 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.
  • 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 [ Time Frame: 7 days ]
  • Comparison between Pain Bloc-R formula, comparator, and placebo in Product perception and tolerability as assessed by the product perception questionnaire [ Time Frame: 7 days ]
    A questionnaire containing 7 questions regarding the participants satisfaction, tolerability, and feelings toward the study product. Answers include strongly agree, agree, no opinion, disagree, and strongly disagree.
Current Other Pre-specified Outcome Measures
 (submitted: May 24, 2019)
  • 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 7 days ]
  • The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on weight from pre-supplementation to Day 7 post-supplementation [ Time Frame: 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 [ Time Frame: 7 days ]
    Weight and Height are measured. BMI is calculated by kg/m2.
  • 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Between 42-87 days ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study to Investigate the Efficacy of Pain Bloc-R in Healthy Participants With Non-pathological Aches and Discomfort
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Randomized, double-blind, placebo-controlled, cross-over
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
All products look identical in identical opaque capsules
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • Dietary Supplement: Pain Bloc-R
    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
  • Other: Active Comparator - Acetaminophen
    DIN 02447479 Encapsulated for Blinding Purposes
  • Other: Placebo
    No active ingredients
Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Dietary Supplement: Pain Bloc-R
    • Other: Active Comparator - Acetaminophen
    • Other: Placebo
  • Experimental: 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.
    Interventions:
    • Dietary Supplement: Pain Bloc-R
    • Other: Active Comparator - Acetaminophen
    • Other: Placebo
  • Experimental: 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.
    Interventions:
    • Dietary Supplement: Pain Bloc-R
    • Other: Active Comparator - Acetaminophen
    • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2019)
27
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 9, 2019
Actual Primary Completion Date August 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males and females 18-65 years of age, inclusive
  2. BMI of 18-32.5 kg/m2, inclusive
  3. Individuals with occupational (construction workers, manual labourers, athletes) and non-occupational unresolved aches and discomfort for at least 2 weeks
  4. 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
  5. 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
  6. Healthy as determined by laboratory results and medical history as assessed by the QI
  7. Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
  8. Agrees to comply with study procedures
  9. Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

  1. Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
  2. Anticipated problems or allergy to any ingredients in the investigational products
  3. Allergy to rescue medication
  4. Have chronic disease conditions causing chronic pain
  5. Uncontrolled high and low blood pressure
  6. Uncontrolled blood sugar levels
  7. Clinically significant abnormal laboratory results at screening
  8. Prescribed medications used to help with aches and discomfort (Section 7.3.1)
  9. OTC medications and supplements taken to help with aches and discomfort (Section 7.3.2)
  10. Autoimmune disease or if immune-compromised (i.e. HIV-positive, use of anti-rejection medication, rheumatoid arthritis, Hepatitis B/C-positive)
  11. 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
  12. History of mental illness that might impair the ability of participants to provide written informed consent
  13. Current or history of bleeding disorders
  14. Current or history of liver or kidney disease as assessed by QI on a case by case basis.
  15. 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
  16. Surgical procedures which may impact the study outcomes within the past 3 months to be assessed by the QI
  17. Medicinal marijuana
  18. Recreational marijuana; dose and frequency to be assessed by QI
  19. Alcohol intake >2 standard drinks per day or >10 standard drinks per week
  20. Illicit drug use in the past 6 months as assessed by the QI
  21. Participation in clinical trials within 30 days prior to screening visit
  22. Blood donation during or within 30 days after conclusion of clinical trial
  23. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03965819
Other Study ID Numbers  ICMJE 18PPHL
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party LifeSeasons Inc.
Study Sponsor  ICMJE LifeSeasons Inc.
Collaborators  ICMJE KGK Science Inc.
Investigators  ICMJE
Principal Investigator: David Crowley, MD Qualified Investigator
PRS Account LifeSeasons Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP