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

NCT03965819 | Completed

• 1 other identifier: 18PPHL
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Aches; Discomfort; Healthy; Adults; Body aches

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

• 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

Other Outcomes (25)

• 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

  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

Study Arms (3)

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.

Dietary Supplement: Pain Bloc-R; Other: Active Comparator - Acetaminophen; Other: Placebo

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.

Dietary Supplement: Pain Bloc-R; Other: Active Comparator - Acetaminophen; Other: Placebo

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.

Dietary Supplement: Pain Bloc-R; Other: Active Comparator - Acetaminophen; Other: Placebo

Interventions

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

Randomized to consume Acetaminophen, Placebo, then Pain Bloc-R; Randomized to consume Pain Bloc-R, Acetaminophen, then placebo; Randomized to consume Placebo, Pain Bloc-R, then Acetaminophen

Active Comparator - Acetaminophen OTHER

DIN 02447479 Encapsulated for Blinding Purposes

Randomized to consume Acetaminophen, Placebo, then Pain Bloc-R; Randomized to consume Pain Bloc-R, Acetaminophen, then placebo; Randomized to consume Placebo, Pain Bloc-R, then Acetaminophen

Placebo OTHER

No active ingredients

Randomized to consume Acetaminophen, Placebo, then Pain Bloc-R; Randomized to consume Pain Bloc-R, Acetaminophen, then placebo; Randomized to consume Placebo, Pain Bloc-R, then Acetaminophen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LifeSeasons Inc.: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6A 5R8, Canada

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Crowley, MD

  Qualified Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All products look identical in identical opaque capsules
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, cross-over

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 29, 2019
• Study Start: May 30, 2019
• Primary Completion: August 9, 2019
• Study Completion: August 9, 2019
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)