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Dietary Supplement

BioPlete™ Advanced Formula for 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
Participant is willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.
Participant who is 30-65 years of age (inclusive).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 21 and 42
Awards & highlights

Study Summary

This study is a randomized, double-blind, placebo controllled parallel design study to evaluate the use of the Foundation Pain Index and the Nutritional Supplement BioPlete™ on quality of life in adults with chronic pain. Eligible participants that provide informed consent and pass the screening visit procedures will be randomized in a 4:1 ratio to active product or placebo at the baseline visit (V2) and will return after 3 and 6 weeks of supplementation for study assessments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
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

Find a Location

Who is running the clinical trial?

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.NETWORK
32 Previous Clinical Trials
1,883 Total Patients Enrolled
Ethos Research & DevelopmentLead Sponsor
2 Previous Clinical Trials
95 Total Patients Enrolled
2 Trials studying Chronic Pain
95 Patients Enrolled for Chronic Pain
Anthony Bier, MDStudy DirectorNutrasource Pharmaceutical and Nutraceutical Services
6 Previous Clinical Trials
296 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Florida
Virginia
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
What site did they apply to?
Model Research Center, LLC
~9 spots leftby Mar 2025