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

NCT ID: NCT03558971

Last Updated: 2018-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2430 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-01-01
• Study Completion Date: 2016-12-31

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.

Conditions

Rheumatic Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patient self-administration of cortisol

Intervention is patient self-administration of cortisol.

Group Type: EXPERIMENTAL

Cortisol

Intervention Type: DRUG

Participants determine when to administer 5-day regimens of cortisol

Interventions

Cortisol

Participants determine when to administer 5-day regimens of cortisol

Intervention Type: DRUG

Other Intervention Names

microdose therapy

Eligibility Criteria

Inclusion Criteria

Clinical diagnoses of fibromyalgia, osteoarthritis, or rheumatoid arthritis -

Exclusion Criteria

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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helen Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Virgil I Stenberg, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of North Dakota

Locations

Helen Foundation Clinic

Apache Junction, Arizona, United States

Countries

United States

References

Stenberg VI, Fiechtner JJ, Rice JR, Miller DR, Johnson LK. Endocrine control of inflammation: rheumatoid arthritis double-blind, crossover clinical trial. Int J Clin Pharmacol Res. 1992;12(1):11-8.

Reference Type: BACKGROUND

PMID: 1526694 (View on PubMed)

Irwin JB, Baldwin AL, Stenberg VI. General theory of inflammation: patient self-administration of hydrocortisone safely achieves superior control of hydrocortisone-responding disorders by matching dosage with symptom intensity. J Inflamm Res. 2019 Jun 13;12:161-166. doi: 10.2147/JIR.S195165. eCollection 2019.

Reference Type: DERIVED

PMID: 31354330 (View on PubMed)

Other Identifiers

HF 101

Identifier Type: -

Identifier Source: org_study_id