NCT03558971

Patient Self-administration of Cortisol for Cortisol-responding Disorders in Men and Women Over the Age of 17

Patient Self-administration of Cortisol for Cortisol-responding Disorders in Men and Women Over the Age of 17, Demonstration of Double-blind Trial Results

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,430 (actual)
• Sponsor: Helen Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Participants diagnosed as having fibromyalgia, osteoarthritis, and rheumatoid arthritis are to be brought to a minimum symptom state using a 3-week period during which they are to ingest modest doses of cortisol tablets with weekly lowered tapered doses. Thereafter, the participants are to be taught to self-administer cortisol tablets on the as-needed basis to maintain the minimum symptom state. For this, they are to ingest a smaller-dosage, 5-day tapered regimen of cortisol tablets to quench each reoccurring exacerbation of the disease at its earliest stage. Participants are limited to using less than the safe use limit of cortisol per month and are required to include a minimum of 10 days per month during which no cortisol was ingested.

Detailed description

OBJECTIVE: To define why and demonstrate how patient self-administration of cortisol with stress management eliminates chronic inflammation pain within fibromyalgia, osteoarthritis, and rheumatoid arthritis. METHODS: One thousand seventeen hundred and twenty (1,720) participants with chronic inflammation-containing diseases, were brought to a minimum symptom state using daily-administered cortisol tablets. Thereafter, participants used 5-day, small-dosage cortisol regimens to quench subsequent disorder exacerbations to maintain the minimum symptom state. Stressors as emotional traumas, infections, allergies, and injuries were minimized to reduce cortisol consumption and participant discomfort. This protocol is compliant with current United States Food and Drug Administration recommendations for cortisol use applied to corticosteroid-responding disorders.

Conditions

• Rheumatic Diseases

Interventions

Type	Name	Description
DRUG	Cortisol	Participants determine when to administer 5-day regimens of cortisol

Timeline

• Start date: 2000-01-01
• Primary completion: 2016-12-31
• Completion: 2016-12-31
• First posted: 2018-06-15
• Last updated: 2018-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study