NCT05213052
Completed
Not Applicable
Document Magnitude and Timing for Pain Relief of Topical Cream
ConditionsChronic Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Natural Immune Systems Inc
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Change in degree of pain
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
To perform a clinical proof-of-concept study on a novel topical formula for pain relief.
Detailed Description
An open-label study where each participant will be involved in the study for 4 weeks. During the study participants will use the topical cream 1-2 times daily on the anatomical area(s) causing the most pain.
Investigators
Eligibility Criteria
Inclusion Criteria
- •BMI between 18.5 and 34.9 kg/m2 (inclusive)
- •Chronic joint/muscle related pain for at least past 6 months
- •Experiencing chronic pain in at least one specific anatomical area for more than 6 months.
Exclusion Criteria
- •Cancer during past 12 months
- •Chemotherapy during past 12 months
- •Currently taking prescription pain medications
- •Getting regular joint injections (such as cortisone shots);
- •Immunization during last month
- •Participation in another clinical trial study during this trial, involving an investigational product or lifestyle change
- •Regularly experiencing headaches, including migraines
- •Serious active illness within past 6 months
- •Significant active uncontrolled illness (such as lymphoma, liver disease, kidney failure, heart failure).
- •Skin allergies related to ingredients in test product.
Outcomes
Primary Outcomes
Change in degree of pain
Time Frame: 4 weeks
Pain questionnaire - yes/no, score 0-24 hours
Secondary Outcomes
- Activity level(4 weeks)
Study Sites (1)
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