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Clinical Trials/NCT05213052
NCT05213052
Completed
Not Applicable

Document Magnitude and Timing for Pain Relief of Topical Cream

Natural Immune Systems Inc1 site in 1 country12 target enrollmentAugust 1, 2021
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.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
May 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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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