Health Condition 1: M058- Other rheumatoid arthritis with rheumatoid factor
Conditions
Interventions
None listed
Sponsors
Valyou Products Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female participants aged over 18 years old with a DAS28_ESR score greater than 2.6. 2.Participants have been diagnosed with RA by a general practitioner and/or orthopedic physician/surgeon according to the 2010 American College of Rheumatology 168 (ACR). 3.Able to evaluate disease activity by themselves. 4.Participants who have no plans to start new treatments during the study period 5.Patients who require anti-inflammatory treatment, do not use anti-inflammatory/analgesic medications on a regular basis, or are unsatisfied with their treatments and want to alter them. 6.Patients ready to give written informed consent and willing to comply the study protocol.
Exclusion criteria
Exclusion criteria: 1. Participants using other complementary and alternative medicine or any addiction to psychotropic agents and opioids. 2. Participants with RA, septic arthritis, during the past 3 months. 3. Participants with uncontrolled medical conditions such as diabetes, uncontrolled hypertension, cardiovascular disease, gallbladder disease, renal disease, endocrine disease, or malignancies, neurological diseases, or psychiatric conditions. 4. Patients with concurrent rheumatoid diseases and gout. Use of biologic agent therapy in the last 6 months. 5. Participation in any other clinical trial within 30 days of screening. 6. Any history of allergy to any of the drugs/investigational products. 7. Pregnant and lactating women and women of childbearing age who do not follow adequate contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline to end of the study in VAS scoreTimepoint: Baseline(Day0), Week 12 and Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline to end of the study in ANA, ESRTimepoint: Baseline(Day0), Week 12 and Week 24;Change from Baseline to end of the study in Disease Activity Score (DAS28)Timepoint: Baseline(Day0), Week 12 and Week 24;Change from Baseline to end of the study in Health-related quality of life (HRQOL) using SF-36 ScoreTimepoint: Baseline(Day0), Week 12 and Week 24;Change from Baseline to end of the study in Ig G, IgM and IgETimepoint: Baseline(Day0), Week 12 and Week 24;Change from Baseline to end of the study in Patient and Physician Global Assessment of disease activityTimepoint: Baseline(Day0), Week 12 and Week 24;Change from Baseline to end of the study in Serum levels of CRP & RA factorTimepoint: Baseline(Day0), Week 12 and Week 24 | — |
Countries
India
Contacts
Public ContactDr Varuni B G
Valyou Products Private Limited
Outcome results
None listed