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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Rheumatic Diseases

Intervention / Treatment
-----------------
* Drug: Cortisol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnoses of fibromyalgia, osteoarthritis, or rheumatoid arthritis - Exclusion Criteria: Congestive heart failure, stomach ulceration, unstable diabetes, and bipolar disorder -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All participants follow the same treatment protocol: First, the participants ingest a defined dosage, 3-week treatment of cortisol tablets to achieve a minimum symptom state. Second, after the first is complete, participants are trained to self-administer small-dosage, 5-day regimens of cortisol tablets to quench disease exacerbations to maintain the minimum symptom state.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient self-administration of cortisol<br>Intervention is patient self-administration of cortisol. | Drug: Cortisol<br>* Participants determine when to administer 5-day regimens of cortisol<br>* Other names: microdose therapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant evaluation of disease symptom intensity | Participants evaluate 50 symptoms for intensity using the 0 to 10 scale. 0 represents no disease intensity and 10 represents extreme maximum symptom intensity with the intermediate numbers defined as Mild I, Mild II, Mild III, Moderate I, Moderate II, Moderate III, Severe I, Severe II, Severe III for 2 through 9, respectively. The participant-determined disease intensity numbers of the 50 symptoms are added to obtain Total Score for each day. | Participants determine Total Scores 7 days prior to cortisol initiation to obtain the average baseline Total Score. Participant Total Score change is plotted daily vs. time for study. Outcome: Total Score at 24 weeks vs. baseline. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cortisol