Patient Self-administration of Cortisol for Cortisol-responding Disorders in Men and Women Over the Age of 17
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|ClinicalTrials.gov Identifier: NCT03558971|
Recruitment Status : Completed
First Posted : June 15, 2018
Last Update Posted : June 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Rheumatic Diseases||Drug: Cortisol||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2430 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|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|
|Actual Study Start Date :||January 1, 2000|
|Actual Primary Completion Date :||December 31, 2016|
|Actual Study Completion Date :||December 31, 2016|
Experimental: Patient self-administration of cortisol
Intervention is patient self-administration of cortisol.
Participants determine when to administer 5-day regimens of cortisol
Other Name: microdose therapy
- Participant evaluation of disease symptom intensity [ Time Frame: 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. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558971
|United States, Arizona|
|Helen Foundation Clinic|
|Apache Junction, Arizona, United States, 85120|
|Principal Investigator:||Virgil I Stenberg, Ph.D.||University of North Dakota|