Arthritis, Joint Pain, Joint Stiffness, Muscle Pain, Musculoskeletal Pain
Conditions
Brief summary
This is a randomized, triple-blind, controlled clinical trial evaluating the effects of Saje Pain Release Joint & Arthritis Cream on symptoms of arthritis, joint pain, and muscle pain in adults aged 20-65. The trial is conducted virtually over seven days, with 80 participants randomized equally into an intervention arm (active topical cream) and a control arm (matched control product). Participants apply their assigned product three times daily to affected areas (knees, elbows, wrists, or ankles) and complete questionnaires at Baseline, 30 minutes after the first application, and at the end of Day 7. The primary objective is to assess changes in arthritis and musculoskeletal pain symptoms, while secondary objectives assess participants' perceptions of joint pain, stiffness, function, comfort, flexibility, mobility, and overall quality of life.
Interventions
DIETARY_SUPPLEMENTIntervention (Saje Pain Release Joint & Arthritis Cream)
40 participants apply a thin layer of the Saje Pain Release Joint \& Arthritis Cream to arthritis-affected areas (knees, elbows, wrists, ankles) three times daily (morning, afternoon, and evening) for seven days
DIETARY_SUPPLEMENTPlacebo Comparator
40 participants apply a matched control product (identical in appearance and consistency to the active product but without active ingredients such as L-menthol and balsam copaiba oil) to arthritis-affected areas three times daily (morning, afternoon, and evening) for seven days
Sponsors
Saie Beauty
Citruslabs
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Be male or female * Be aged 20-65 * Has experienced issues regarding all of the following in the past four weeks: symptoms of arthritis of the knees, elbows, wrists, or ankles * joint pain and stiffness * Self-reported issues must be at least 3 out of 10 in severity, with 1 being the least severe and 10 being the most * Generally healthy - does not live with any uncontrolled chronic disease * If taking oral over-the-counter supplements or herbal remedies targeted at symptoms of arthritis, joint and muscle pain, has been consistently taking these for at least 3 months prior to starting the study, and is willing to maintain this routine for the study duration * Willing to avoid introducing any new forms of prescription medication or supplements that target symptoms of arthritis, joint and muscle pain for the study duration * Resides in the United States * Willing to maintain their current diet, sleep pattern, and activity levels for the duration of the trial
Exclusion criteria
* Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders * Anyone with any allergies or sensitivities to any of the study product ingredients * Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period) * Symptoms occurring in a joint that has been surgically repaired * Anyone unwilling to follow the study protocol * Anyone who identifies as having sensitive skin * Anyone with any history of skin cancer or any pre-cancerous lesions on their skin * Anyone with a history of substance abuse * Anyone who is currently a smoker or has been a smoker in the past 3 months * Currently partaking in another research study or will be partaking in any other research study at any point during this study's duration * Anyone with chronic skin conditions (e.g., dermatitis, eczema, psoriasis) * Anyone who currently takes prescription pain relief to manage their symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in symptoms of arthritis | Baseline, 30 minutes after first application, and Day 7 | Assessed via self-reported numerical pain rating scale and the Musculoskeletal Health Questionnaire (MSK-HQ) validated questionnaire |
| Change in symptoms of joint pain | Baseline, 30 minutes after first application, and Day 7 | Assessed via self-reported numerical pain rating scale and the Musculoskeletal Health Questionnaire (MSK-HQ) validated questionnaire |
| Change in symptoms of muscle pain | Baseline, 30 minutes after first application, and Day 7 | Assessed via self-reported numerical pain rating scale and the Musculoskeletal Health Questionnaire (MSK-HQ) validated questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in self-reported joint pain | Baseline, 30 minutes after first application, and Day 7 | Assessed via self-reported questionnaire |
| Change in self-reported joint stiffness | Baseline, 30 minutes after first application, and Day 7 | Assessed via self-reported questionnaire |
| Change in self-reported joint function | Baseline, 30 minutes after first application, and Day 7 | Assessed via self-reported questionnaire |
| Change in self-reported joint comfort | Baseline, 30 minutes after first application, and Day 7 | Assessed via self-reported questionnaire |
| Change in self-reported flexibility | Baseline, 30 minutes after first application, and Day 7 | Assessed via self-reported questionnaire |
| Change in self-reported mobility | Baseline, 30 minutes after first application, and Day 7 | Assessed via self-reported questionnaire |
| Change in self-reported quality of life | Baseline, 30 minutes after first application, and Day 7 | Assessed via self-reported questionnaire |
| Change in self-reported overall health | Baseline, 30 minutes after first application, and Day 7 | Assessed via self-reported questionnaire |
Countries
United States
Outcome results
None listed