NCT05213052CompletedNot Applicable
Document Magnitude and Timing for Pain Relief of Topical Cream
Natural Immune Systems Inc2 sites in 1 country12 target enrollmentStarted: August 1, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Natural Immune Systems Inc
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Change in degree of pain
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Investigators
Study Sites (2)
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