Health Condition 1: M069- Rheumatoid arthritis, unspecified
Conditions
Interventions
Intervention1: Glycyrrhiza glabra extract along with standard of care (SOC): Two capsules twice daily (four capsules per day) 30 minutes after breakfast and dinner with 240 ml of water along with SOC
Sponsors
SAVA HEALTHCARE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female participants 30 to 60 years of age (both inclusive) who present RA (rheumatoid arthritis), diagnosed according to ACR or EULAR 2010 criteria with a total score of greater than equal to 6 2. Mild disease activity, indicated by a DAS 28 score greater than equal to 2.6 to smaller than 3.2 3. Participant exhibiting clinically apparent symptoms such as joint swelling and tenderness greater than equal 12 weeks.4. Participants should have been diagnosed with rheumatoid arthritis within the past 3 months and their dose of disease-modifying antirheumatic drug(s) must have been stable for at least 8 weeks prior to trial participation.5. Participants having VAS score in between 4 to 6 . 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 or history of dengue and chikungunya, other arthritis like, gouty arthritis, tuberculous arthritis etc. However, participants with radiologically confirmed osteoarthritis (OA) may be excluded at the investigators discretion if the severity of osteoarthritis is judged to interfere with the study assessment 3. Participants undergoing physiotherapy or oil massages for pain relief. 4. Allergy, sensitivity, or contraindication to interventional product 5. Participants receiving anticoagulant and or antiplatelet agents (high dose aspirin (greater than 100 mg per day) 6. Participants who are unable to walk without support and or confined to a wheelchair 7. Participants with a history of or currently on a biologic (tumor necrosis factor blocking agents) or targeted synthetic DMARDs treatment or other biologic treatment 8. Use of corticosteroids within 2 weeks prior to study entry or planned use within 12 weeks of randomization 9. Chronic antibiotic therapy, if the investigator considers this may affect the safety of the participant or the assessment of the study results 10. History of psychiatric disorder that may impair the ability of the participant to provide written informed consent 11. A history presenting RA encompassing more than a year 12. Participation in any RA-related or any other trials involving investigational products within 30 days before the screening visit 13. Participants treated with any investigational drug in the preceding 4 weeks 14. Female participants with a positive pregnancy test or lactating 15. History of drug, alcohol abuse or dependence 16. History of septic arthritis within a native joint within the last 12 months 17. Organ transplantation history 18. Participants unable to comply with the treatment regimen 19. Participant currently using any enzyme, nutraceutical, ayurvedic, herbal supplement for RA 20. 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. Achieving the American College of Rheumatology (ACR20) Responder Index It is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA) 2. Changes in Visual Analogue Scale (VAS) pain score. 3. Change in the Disease Activity Score Based on a 28-joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP) 4. Changes in the levels of urinary CTX-II, serum hsCRP, s-CoLL2-1NO2,s-COMP.Timepoint: 1.At baseline and day 90. 2.At screening, baseline, day 7, day 30, day 60 and day 90. 3. At screening and day 90. 4. At screening and day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Median of individual participants mean duration of morning joint stiffness based on a 7 day recall at baseline, and recorded in participant diaries . 2. Mean severity of morning joint stiffness using Numeric Rating Scale (NRS) based on a 7 day recall at baseline, and recorded in participant diaries . 3. Change from baseline in the Indian version of the Health Assessment Questionnaire disability index (HAQ DI) score . 4. Mean worst tiredness using numeric rating scale based on a 7 day recall at baseline, and recorded in participant diaries 5. Assessment of requirement of anti inflammatory and analgesic (eterocoxib) as a rescue medication . Timepoint: 1.At day 7, day 30, day 60 and day 90. 2. Day 7, day 30, day 60 and day 90. 3.Baseline and day 90. 4.At day 7, day 30, day 60 and day 90. 5.At day 7, day 30, day 60 and day 90 | — |
Countries
India
Contacts
Public ContactDr Sriram Padmanabhan
SAVA HEALTHCARE LIMITED
Outcome results
None listed