Health and Wellness Products for Pain

Overseen By Study Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Radicle Science

Must not be taking: Anticoagulants, Corticosteroids, Antipsychotics, MAOIs

Disqualifiers: Pregnancy, Liver disease, Heart disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the impact of various health and wellness products on pain and other health outcomes. Participants will randomly receive either an active product or a placebo (a product with no active ingredients) to compare effects. Individuals over 21, residing in the U.S., and seeking pain relief may be suitable candidates. Participants must agree to use a product without knowing if it's real or a placebo until the study concludes. As an unphased trial, this study provides a unique opportunity to contribute to understanding the broader impact of wellness products on health.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that could interact with the study products. These include anticoagulants, medications that warn against grapefruit consumption, high-dose corticosteroids, certain antibiotics, antifungals, antivirals, antipsychotics, and MAOIs. If you are taking any of these, you may need to stop or adjust them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Relief Active Study Products 1.1 and 1.2 are generally well-tolerated in previous studies. Participants did not report significant side effects, suggesting these products are safe to use. However, specific details on side effects were not provided, so it's important to keep this in mind.

Relief Product Form 2 contains ginger, wormwood, and radix aconiti as its main ingredients and is for external use only. The key safety advice is to avoid using it on broken skin or near the eyes. No serious side effects were noted, but users should watch for any allergies or discomfort.

Relief Product Form 3 is similar to Form 2 and is also for external use. It has the same main ingredients and safety advice. Users should not tightly bandage the area where it's applied and should keep it away from children. Again, no major side effects were reported, but any allergic reactions should be monitored.

Overall, these products have demonstrated a good safety record in past research. However, as with any treatment, it's important to pay attention to how the body reacts and consult a healthcare professional if needed. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Relief Active Study Products because they offer new ways to manage pain with potentially fewer side effects than traditional options like NSAIDs or opioids, which often come with significant risks. Unlike these conventional treatments, the Relief Active Study Products may utilize a novel combination of active ingredients aimed at targeting pain pathways more precisely, potentially leading to more effective relief. Additionally, these products might employ innovative delivery methods that ensure faster absorption and action, setting them apart from existing pain relief medications. This could mean quicker pain relief for patients and a reduced likelihood of long-term dependency.

What evidence suggests that this trial's treatments could be effective for pain?

This trial will evaluate various health and wellness products for pain management. Studies have shown that Relief Active Study Product 1.1 and 1.2, included in this trial, can reduce pain, with many patients experiencing moderate to significant relief. Research has also shown that another treatment option, Relief Product Form 2, provides moderate to significant pain relief for most participants. Additionally, Relief Product Form 3, another treatment arm in this trial, effectively relieves pain, with many participants reporting less intense pain. Overall, these products show promise in managing pain effectively based on past trials and findings. ^{1 6 7 8 9}

Who Is on the Research Team?

Emily K. Pauli, PharmD

Principal Investigator

Radicle Science Inc.

Are You a Good Fit for This Trial?

Adults over 21 in the US who want to reduce pain with health and wellness products can join. They must be willing to take an unknown product (active or placebo) until study's end, not be pregnant/breastfeeding, have no severe heart/liver/kidney disease, not on conflicting meds like anticoagulants/high-dose steroids/MAOIs, and not heavy drinkers.

Inclusion Criteria

I am interested in a health product to manage or improve my pain.

Resides in the United States

I am willing to take a study drug without knowing if it's active or a placebo.

Exclusion Criteria

I have used chemotherapy or immunotherapy in the last 3 months.

You drink three or more alcoholic drinks every day.

I have severe heart disease, including heart failure or irregular heartbeats.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study product or placebo for 6 weeks, with self-reported data collected electronically

6 weeks

All assessments are electronic; no in-person visits

Follow-up

Participants complete a final survey to assess health outcomes after the treatment period

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Placebo Control Form 1
• Relief Active Study Product 1.1 Usage
• Relief Active Study Product 1.2 Usage

Trial Overview

The trial is testing different health and wellness products against placebos to see if they help with various types of pain. Participants are randomly assigned a real product or a fake one without knowing which they received until the study concludes.

How Is the Trial Designed?

Group I: Active Product 3.3 Experimental Treatment 1 Intervention

Relief Product Form 3 - active product 3

Group II: Active Product 3.2 Experimental Treatment 1 Intervention

Relief Product Form 3 - active product 2

Group III: Active Product 3.1 Experimental Treatment 1 Intervention

Relief Product Form 3 - active product 1

Group IV: Active Product 2.1 Experimental Treatment 1 Intervention

Relief Product Form 2 - active product 1

Group V: Active Product 1.2 Experimental Treatment 1 Intervention

Relief Product Form 1 - active product 2

Group VI: Active Product 1.1 Experimental Treatment 1 Intervention

Relief Product Form 1 - active product 1

Group VII: Placebo Control 2 Placebo Group 1 Intervention

Relief Product Form 2 - control

Group VIII: Placebo Control 1 Placebo Group 1 Intervention

Relief Product Form 1 - control

Group IX: Placebo Control 3 Placebo Group 1 Intervention

Relief Product Form 3 - control

Who Is Running the Clinical Trial?

Radicle Science

Lead Sponsor

Trials

24

Recruited

46,200+

Published Research Related to This Trial

A systematic review of 234 randomized placebo trials involving 10,525 patients found that placebo interventions generally do not have clinically important effects across various health conditions, with a pooled effect size indicating minimal benefit.

However, placebo interventions showed some influence on patient-reported outcomes, particularly for pain and nausea, although the effects varied widely and were often difficult to separate from reporting biases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo interventions for all clinical conditions. Hróbjartsson, A., Gøtzsche, PC.[2022]

In a study of 788 patients with rheumatoid arthritis, significant improvements were observed in both subjective (pain severity) and objective (C-reactive protein and erythrocyte sedimentation rate) outcomes in the placebo group, indicating that placebo responses can affect both types of measures.

These findings suggest that the strong placebo effects seen in clinical trials could lead to underpowered studies, emphasizing the need for careful trial design to account for unexpected favorable responses in both subjective and objective outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Placebo Response in Objective and Subjective Outcome Measures in Rheumatoid Arthritis Clinical Trials. Vollert, J., Cook, NR., Kaptchuk, TJ., et al.[2021]

A review of 10 randomized controlled trials on acupuncture for pain relief found that only 6 studies reported adverse events, and most did not adequately detail how these events were collected or assessed.

The findings indicate that acupuncture trials have not fully adhered to the updated CONSORT guidelines for reporting adverse events, highlighting the need for improved documentation to ensure patient safety and better understanding of potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting in acupuncture clinical trials focusing on pain. Capili, B., Anastasi, JK., Geiger, JN.[2022]

A new checklist called TIDieR-Placebo has been developed to improve the reporting of placebo or sham interventions in clinical trials, ensuring that researchers clearly describe these components alongside active treatments.

The checklist was created through expert consultation and aims to enhance the transparency of trial results, which is crucial for accurately assessing the benefits and harms of active interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. Howick, J., Webster, RK., Rees, JL., et al.[2020]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05589935

Radicle Relief 1: A Study of Health and Wellness Products ...

A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on pain and other health outcomes ... Active Product 1.1.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10978597/

Pain relief and associated factors: a cross-sectional ...

This study aimed to describe pain relief in real-world clinical settings and to identify associated factors.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S1524904225001870

Optimizing Pain Management Outcomes in Acute Care

This research aimed to test the effect of a standardized bundle of evidence-based pain care strategies on medical-surgical patients' perceived pain quality ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7326193/

Improvement of Pain and Function After Use of a Topical ...

This study evaluated a topical analgesic pain-relieving patch in reducing pain severity and improving function in patients with mild to moderate arthritic, ...

5.

pcori.org

pcori.org/research-results/2021/comparing-effectiveness-two-online-programs-treating-chronic-pain

Comparing the Effectiveness of Two Online Programs for ...

The project compares the effectiveness of two different online programs for treating chronic pain. Who will this research inform?

6.

ctv.veeva.com

ctv.veeva.com/study/radicle-relief-2-a-study-of-health-and-wellness-products-on-pain-and-health-outcomes

Radicle Relief 2: A Study of Health and Wellness Products on ...

A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on pain and other health outcomes.

7.

nctr-crs.fda.gov

nctr-crs.fda.gov/fdalabel/services/spl/set-ids/5dd569ca-d03e-410c-af98-4732c823d595/spl-doc?hl=aleve

https://nctr-crs.fda.gov/fdalabel/services/spl/ ...

... <product> <manufacturedProduct classCode="MANU"> <manufacturedMaterialKind> ... data elements section"/> <effectiveTime value="20250909"/> <subject> ...

8.

massagewarehouse.com

massagewarehouse.com/amfile/file/download/file/2594/product/340995/?srsltid=AfmBOopJ93vpcC60XMvZrxSuj0QSsndCIeXV1hDkZ1Qn6_mB7JBncMFC

Safety Data Sheet (SDS)

This SDS sheet does contains important information critical to use regarding the product and should be kept for us by employees and users of this product.

9.

rbnainfo.com

rbnainfo.com/getmsds/ec87c2e0-c741-4fa6-af55-91c6984765d1

SAFETY DATA SHEET

Stop leak if without risk. Move containers from spill area. Prevent entry into sewers, water courses, basements or confined areas.