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Dietary Supplement

Evaluate the Use of the Foundation Pain Index and the Nutritional Supplement BioPlete™ in Adults With Chronic Pain

N/A
Waitlist Available
Led By Pamela Kane
Research Sponsored by Ethos Research & Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 21 and 42

Summary

This trial is testing a new pain measurement test and a nutritional supplement in adults with chronic pain. The test identifies markers related to pain, and the supplement aims to improve pain by addressing nutritional issues.

Eligible Conditions
  • Chronic Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 21 and 42
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 21 and 42 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline (Day 0) in 36-Item Short Form Survey (SF-36) questionnaire scores (0-100; higher is better), assessed on Day 42.
Secondary study objectives
Change from baseline (Day 0) in 36-Item Short Form Survey (SF-36) questionnaire scores (0-100; higher is better), assessed on Day 21.
Change from baseline (Day 0) in Foundation Pain Index (FPI) (0-100; higher is worse), assessed on Days 21 and 42.
Change from baseline (Day 0) in Numeric Rating Scale (NRS) scores for pain (0-10, higher is worse), assessed on Days 21 and 42.
Other study objectives
Change from baseline (Day 0) in Morphine Milligrams Equivalent (MME), assessed on Days 21 and 42.
Within the confines of this study design, duration and population, to determine change from baseline (Day 0) the relative safety of the Test Product over 1.5 months of use.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BioPlete™ Advanced FormulaExperimental Treatment1 Intervention
BioPlete™ Advanced Formula in Capsule Intervention: Dietary Supplement: Multi-Vitamin
Group II: PlaceboPlacebo Group1 Intervention
Rice Flour in a capsule Intervention: Other: Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BioPlete™ Advanced Formula
2021
N/A
~30

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Who is running the clinical trial?

Ethos Research & DevelopmentLead Sponsor
2 Previous Clinical Trials
95 Total Patients Enrolled
2 Trials studying Chronic Pain
95 Patients Enrolled for Chronic Pain
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.NETWORK
36 Previous Clinical Trials
2,072 Total Patients Enrolled
Anthony Bier, MDStudy DirectorNutrasource Pharmaceutical and Nutraceutical Services
7 Previous Clinical Trials
328 Total Patients Enrolled
Pamela KanePrincipal InvestigatorPrincipal Investigator
1 Previous Clinical Trials
500 Total Patients Enrolled
1 Trials studying Chronic Pain
500 Patients Enrolled for Chronic Pain
~7 spots leftby Dec 2025
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