Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03558971
Recruitment Status : Completed
First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Helen Foundation

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.

Condition or disease Intervention/treatment Phase
Rheumatic Diseases Drug: Cortisol Phase 4

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.


Layout table for study information
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)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Patient self-administration of cortisol
Intervention is patient self-administration of cortisol.
Drug: Cortisol
Participants determine when to administer 5-day regimens of cortisol
Other Name: microdose therapy




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Clinical diagnoses of fibromyalgia, osteoarthritis, or rheumatoid arthritis -

Exclusion Criteria:

Congestive heart failure, stomach ulceration, unstable diabetes, and bipolar disorder

-


Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Arizona
Helen Foundation Clinic
Apache Junction, Arizona, United States, 85120
Sponsors and Collaborators
Helen Foundation
Investigators
Layout table for investigator information
Principal Investigator: Virgil I Stenberg, Ph.D. University of North Dakota

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Helen Foundation
ClinicalTrials.gov Identifier: NCT03558971     History of Changes
Other Study ID Numbers: HF 101
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Plan to publish the study, its results and conclusions

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Helen Foundation:
Cortisol
Additional relevant MeSH terms:
Layout table for MeSH terms
Rheumatic Diseases
Collagen Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents