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

Sponsor
Helen Foundation (Other)
Overall Status
Completed
CT.gov ID
NCT03558971
Collaborator
(none)
2,430
Enrollment
1
Location
1
Arm
204
Actual Duration (Months)
11.9
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
2430 participants
Allocation:
N/A
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.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 :
Jan 1, 2000
Actual Primary Completion Date :
Dec 31, 2016
Actual Study Completion Date :
Dec 31, 2016

Arms and Interventions

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 Names:
  • microdose therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Participant evaluation of disease symptom intensity [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Clinical diagnoses of fibromyalgia, osteoarthritis, or rheumatoid arthritis -

    Exclusion Criteria:

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

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Helen Foundation Clinic Apache Junction Arizona United States 85120

    Sponsors and Collaborators

    • Helen Foundation

    Investigators

    • Principal Investigator: Virgil I Stenberg, Ph.D., University of North Dakota

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Helen Foundation
    ClinicalTrials.gov Identifier:
    NCT03558971
    Other Study ID Numbers:
    • HF 101
    First Posted:
    Jun 15, 2018
    Last Update Posted:
    Jun 15, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Rheumatic Diseases
    Collagen Diseases
    Hydrocortisone

    Study Results

    No Results Posted as of Jun 15, 2018