Health Condition 1: M069- Rheumatoid arthritis, unspecified
Conditions
Interventions
Intervention1: One EnMax DS tablet + Standard of care (DMARDs i.e. methotrexate, leflunomide, hydroxychloroquine, and sulfasalazine alone or in combination): Twice daily, on an empty stomach with 240
Sponsors
Advanced Vital Enzymes P. Ltd. (Advenza)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female participants 30-60 years of age (both inclusive), who present RA (rheumatoid arthritis), diagnosed according to ACR or EULAR 2010 criteria;2.Mild to moderate disease activity, according to DAS 28 (Erythrocyte Sedimentation Rate ESR) greater than an equal to 3.2;3. Participant exhibiting clinically apparent symptoms such as joint swelling and tenderness greater than an equal to 6 weeks;4. Participant on stable medication that is DMARDs that is methotrexate, leflunomide, hydroxychloroquine, and sulfasalazine greater than an equal to 3 months for RA;5. Participants having VAS score in between 4 to 8;6. Willing to give informed consent for the study.
Exclusion criteria
Exclusion criteria: 1. Participants with other systemic complications of RA like rheumatic heart disease (RHD), rheumatic fever, pleural pericardial disease;2. Participants diagnosed with other arthritis like gouty arthritis, and tuberculous arthritis. However, participants with radiologically confirmed osteoarthritis may be excluded at the investigators discretion if the severity of OA is judged to interfere with the study assessment; 3. Allergy, sensitivity, or contraindication to interventional product; 4.Participants receiving anticoagulant and or antiplatelet agents; 5.Participants who are unable to walk without support and or confined to a wheelchair; 6.Past history of TNF (tumor necrosis factor) blocking agents or other biologic treatment; 7.Chronic antibiotic therapy, if the investigator considers this may affect the safety of the subject or the assessment of the study results; 8.History of psychiatric disorder that may impair the ability of participant to provide written informed consent; 9.A history presenting RA encompassing more than a year; 10.Participation in any RA related or any other trials involving investigational products within 30 days prior to the screening visit; 11.Participants treated with any investigational drug in the preceding 4 weeks; 12.Female participants with a positive pregnancy test or lactating; 13.History of drug abuse or dependence; 14.History of septic arthritis within a native joint within the last 12 months; 15.Presence of a transplanted organ; 16.Participants unable to comply with the treatment regimen; 17.Participant currently using any enzyme, nutraceutical, ayurvedic, herbal supplement for RA; 18.Participants with any other condition that, in the opinion of the investigator, does not justify the inclusion of the participant in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assessment of disease activity score (DAS-28) 2. Changes in Visual Analogue Scale (VAS) pain score 3. Assessment of changes in the duration of the morning stiffness (minutes)Timepoint: 1. At screening, day 1, day 15, day 30, and day 45. 2. At screening, day 1, day 15, day 30, and day 45. 3. At day 1, day 15, day 30 and day 45. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in biomarkers such as TNF-Alpha, IL-1, IL-6, hsCRP, MMP 3, ESR 2. Changes in physician’s global assessment score 3. Changes in requirement of analgesic as a rescue medication 4. Assessment of Indian version of the Health Assessment Questionnaire (HAQ-DI) disability index score 5. Changes in symptom score on 4- point Linkert scale for symptoms of heartburn, gastric discomfort & epigastric painTimepoint: 1. At day 1 and day 45. 2. At day 45. 3. At day 1, day 15, day 30, and day 45. 4. At day 1, day 15, day 30, and day 45. 5. At day 1, day 15, day 30 and day 45. | — |
Countries
India
Contacts
Public ContactDr Gayatri Ganu
Advanced Vital Enzymes P. Ltd. (Advenza)
Outcome results
None listed