Juvenile arthritis is one of the most challenging conditions we’ve addressed—not just because of its complexity, but because it affects children. When standard anti-inflammatory therapies fail, families are left with few options. That’s why we conducted this Kre-Celazine juvenile arthritis study—a pilot trial in children who were unresponsive to conventional treatment. The results, including the normalized range of motion for all participants, offer hope and a clinically validated pathway for brands serving this underserved population.
Kre-Celazine® as a Viable Treatment for Juvenile Rheumatoid/Idiopathic Arthritis: A Pilot Study
Jeff Golini, Wendy Jones, MS
All American Pharmaceutical, Billings, MT, and Royal Knight, Incorporated, Rochester, MN
Background
Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) is a physiologically complex, chronic, childhood, autoimmune–related inflammatory disease of unknown etiology. An initial diagnosis has been confirmed in infants less than one year and in individuals older than 17 years. The unpredictability of onset and progression makes treatment particularly challenging, especially when conventional therapies fail or produce unwanted side effects in growing children.
Only two of the three sub-classifications: pauciarticular (affecting four or fewer joints), and polyarticular (impacting at least five joints) have shown a clear female gender preference. Systemic onset displays no gender preference and is the most aggressive, fibril-forming, and multi-organ-involved. Children with systemic onset often face the poorest prognosis, underscoring the urgent need for safe, effective interventions that can complement or replace standard pharmaceutical approaches.
Study Objective
Ascertain whether an oral, non-prescription nutritional supplement (proprietary alkali-buffered creatine monohydrate and cetylated fatty acids mixture) was efficacious in reducing/eliminating refractory pain and inflammation without untoward effects.
Participants and Method
Juveniles less than 17 years of age, with confirmed JRA/JIA, unresponsive to standard anti-inflammatory therapy, and who demonstrated palpable signs of inflammation, restricted range of motion, elevated inflammatory markers: CRP, ANA, and accelerated ESR.
Each participant received 2 750-mg capsules (total 1,500 mg) of Kre-Celazine®. This dose was taken daily (one in the morning and one in the evening) on an empty stomach, only with water, for 30 consecutive days.
Each family was provided with a Pain Journal to be completed weekly, indicating the perceived level of physical discomfort for each afflicted joint. At the conclusion of the 30-day treatment period, each individual returned to the hospital for re-examination and a fasting blood draw.
Results
By the end of the study, the range of motion was rated ‘normal’ by all physicians—a remarkable outcome given that these children had previously failed to respond to standard anti-inflammatory therapies. Two participants reported feeling “Fully recovered” and began playing basketball at their school, resuming normal childhood activities that had been impossible due to pain and stiffness. (Detailed numbers can be seen by clicking the Research Poster Presentation image below)
Summary
The study demonstrated the safety and efficacy of this treatment in juveniles who had not obtained satisfactory relief from their previous prescription medication.
Kre-Celazine® is capable of significantly improving or resolving unresolved JRA/JIA symptoms without undesirable side effects.
Research Poster Presentation Image:
