Effects of Topical Cream for Pain Relief

Chronic Pain Clinical Trial

Official title:

Document Magnitude and Timing for Pain Relief of Topical Cream

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05213052
• Other study ID #: 173-001
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: May 2022
• Source: Natural Immune Systems Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To perform a clinical proof-of-concept study on a novel topical formula for pain relief.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• Topical cream
Topical cream applied to painful joint or muscle

Locations

Country	Name	City	State
United States	Gitte Jensen	Klamath Falls	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Natural Immune Systems Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Wellness	Wellness questionnaire - Score 0-10 [0 being strongly disagree, 10 being strongly agree]	4 weeks
Primary	Change in degree of pain	Pain questionnaire - yes/no, score 0-24 hours	4 weeks
Secondary	Activity level	Activities of daily living questionnaire	4 weeks