Health Condition 1: M069- Rheumatoid arthritis, unspecified
Conditions
Interventions
None listed
Sponsors
Eutherva Medicament Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Male and female participants aged over 20-65 years 2) Participants have been diagnosed with rheumatoid arthritis by a general practitioner and or orthopedic physician or 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 uncontrolled medical conditions such as diabetes, uncontrolled hypertension, cardiovascular disease, gallbladder disease, renal disease, endocrine disease, or malignancies, neurological diseases, or psychiatric conditions. 3) Patients with concurrent rheumatoid diseases and gout. Use of biologic agent therapy in the last 6 months. 4) Participation in any other clinical trial within 30 days of screening. 5) Any history of allergy to any of the drugs investigational products. 6) Pregnant and lactating women and women of childbearing age who do not follow adequate contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Change in pain levels assessed by the Visual Analogue Scale (VAS) score from baseline to the end of the treatment. 2) Improvement in sleep quality as measured by the Athens Insomnia Scale (AIS) scores, from baseline to the end of the study.Timepoint: Visit-01, Visit-02, Telephonic Visit, Visit-04 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in serum cortisol levels from baseline to the end of treatment. 2) Change in serum levels of C - reactive protein (CRP) from baseline to the end of treatment. 3) Change in Erythrocyte Sedimentation Rate (ESR) from baseline to the end of treatment. 4) Change in Health-Related Quality of Life (HRQOL) Using the SF-36 Score. 5) Changes in overall health status and treatment effectiveness assessed by Subject Global Assessment (SGA) and Physician Global Assessment (PGA) scores from baseline to the end of treatment. 6) Change in vital signs, and laboratory safety parameters including CBC, liver function tests (SGPT and SGOT) and kidney function tests (Sr. creatinine). 7) Incidence of adverse events related to the study interventions recorded throughout the study period.Timepoint: Visit-01, Visit-02, Telephonic Visit, Visit-04 | — |
Countries
India
Contacts
Public ContactMr Manik Chaudhuri
Xplora Clinical Research Services Pvt. Ltd.
Outcome results
None listed