- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03965819
A Study to Investigate the Efficacy of Pain Bloc-R in Healthy Participants With Non-pathological Aches and Discomfort
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 5R8
- KGK Science Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
No active ingredients
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
DIN 02447479 Encapsulated for Blinding Purposes
|
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.
|
No active ingredients
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
DIN 02447479 Encapsulated for Blinding Purposes
|
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.
|
No active ingredients
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
DIN 02447479 Encapsulated for Blinding Purposes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
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. |
7 days
|
Secondary Outcome Measures
Outcome Measure |
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
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.
|
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
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. |
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
Time Frame: 7 days
|
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.
|
7 days
|
Other Outcome Measures
Outcome Measure |
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
Time Frame: 7 days
|
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
|
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
|
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
|
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
|
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.
|
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
Time Frame: Between 42-87 days
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
Between 42-87 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David Crowley, MD, Qualified Investigator
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18PPHL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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