Evaluate the Use of the Foundation Pain Index and the Nutritional Supplement BioPlete™ in Adults With Chronic Pain
CompletedNot applicableNCT05278533
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Prospective, Randomized, Double-blind, Placebo-controlled, Early-stage Study to Evaluate the Use of the Foundation Pain Index and the Nutritional Supplement BioPlete™ on Quality of Life in Adults With Chronic Pain
- Conditions
- Interventions
- Dietary supplement: BioPlete™ Advanced Formula
- Dietary supplement: Placebo
- Sponsor
- Ethos Research & Development
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Start date
- 2021-11-02
- Primary completion
- 2022-10-05
- Sex
- All
- Age range
- from 30 Years to 65 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Participant who is 30-65 years of age (inclusive). 2. Participant has been diagnosed with chronic pain (verbal confirmation from participant, physician records not needed) for more than 2 years at screening. 3. Participant with long term (more than 3 months) and current use of prescribed opioid medication for pain management, with a stable dosage at least 3 months prior to screening. 4. Participant scores a 7 or higher at the screening visit on an 11-point NRS for "average pain or discomfort over the past month", or participant scores 40 or higher on the MME Scale at the screening visit, or both. 5. Participant has a body mass index (BMI) range of 18.0 - 40.0 kg/m2 (inclusive). 6. Female participants of childbearing potential (i.e., participants who are not surgically sterilized or not post-menopausal \[defined as amenorrhea for greater than 1 year\], or transgendered males with retained ovaries and uterus) must agree to use a medically approved method of birth control or abstain from heterosexual intercourse throughout the duration of the study and have a negative urine pregnancy result at screening. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner must be used, or abstinence from heterosexual intercourse. 7. 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. Exclusion Criteria: 1. Participant has uncontrolled hypotension (defined as \<90 mmHg systolic and/or \<60 mmHg diastolic). 2. Participant has a medical history of heart disease/cardiovascular disease, kidney disease (dialysis or renal failure), or hepatic impairment. 3. Participant has a medical history of previously diagnosed major affective disorder, psychiatric disorder that required hospitalization in the year prior to the screening visit, immune disorder (i.e., HIV/AIDS), a history of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit). 4. Participant has a condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data. 5. Participant is currently taking any dietary supplement that contains active ingredients known to modulate FPI scoring i.e., any active ingredients in the Test Pr…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05278533