Trivalent Chromium Treatment for Rheumatoid Arthritis

Study Overview
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Brief Summary
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Trivalent chromium has shown good results in abolishing inflammation and had a successful result in treating animal model of rheumatoid arthritis. In addition to that, trivalent chromium lacks many side effects which are related to the already known medications of the disease. So this study aims to evaluate the efficacy of trivalent chromium supplementation in rheumatoid arthritis treatment and measuring the outcomes of that in rheumatoid arthritis patients.

Detailed Description
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Rheumatoid arthritis is a debilitating autoimmune disease which is treated by medications that have many side effects. Trivalent chromium, a naturally occurring element with regulatory effects on blood sugar, has shown anti-inflammatory properties in many studies and has shown a good response at alleviation of rheumatoid arthritis in the disease animal model. For these reasons trivalent chromium should be tried in rheumatoid arthritis patients.

Official Title
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Trivalent Chromium as a Treatment for Rheumatoid Arthritis Patients

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Trivalent chromium versus synthetic and/ or biological DMARDs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: rheumatoid arthritis Exclusion Criteria: other autoimmune diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Trivalent chromium<br>A dietary supplement already available in market one of its known uses is to control diabetes. | Drug: Trivalent chromium versus synthetic and/ or biological DMARDs<br>* Supplement and immunesuppressants<br>* Other names: Pure trivalent chromium (not in the form of a compound) and treatments the patients are already taking in comparison;|
| Active Comparator: Immunesuppressants<br>Synthetic and/ or biological DMARDs | Drug: Trivalent chromium versus synthetic and/ or biological DMARDs<br>* Supplement and immunesuppressants<br>* Other names: Pure trivalent chromium (not in the form of a compound) and treatments the patients are already taking in comparison;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arthritis scored by DAS28 score | DAS 28 is a score of arthritis | three months | 
| ESR in mm/hr | lab measures for disease activity | three months | 
| CRP mg/dL | lab measures for disease activity | three months | 
| Radiological investigations if required (X-RAY, ultrasound, MRI, bone scan) | To assess joints and bone | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum urea | A renal function test to exclude trivalent chromium side effects. | three months | 
| serum creatinine | A renal function test to exclude trivalent chromium side effects. | three months | 
| SGOT | A liver function test to exclude trivalent chromium side effects. | three months | 
| SGPT | A liver function test to exclude trivalent chromium side effects. | three months |