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OpenTrials
Completed

NCT Number: NCT05213052

Effects of Topical Cream for Pain Relief

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

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gitte Jensen

Klamath Falls, Oregon, 97601-5904, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topical cream

Other

Topical cream applied to painful joint or muscle

Primary outcomes

  1. Change in degree of pain

    Time frame: 4 weeks

    Pain questionnaire - yes/no, score 0-24 hours

Secondary outcomes

  1. Activity level

    Time frame: 4 weeks

    Activities of daily living questionnaire

Other outcomes

  1. Wellness

    Time frame: 4 weeks

    Wellness questionnaire - Score 0-10 [0 being strongly disagree, 10 being strongly agree]

Sponsors and collaborators

Lead sponsor

Natural Immune Systems Inc

Other

Registry information

Official study title

Document Magnitude and Timing for Pain Relief of Topical Cream

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2022
Registry last updated
Jun 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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