Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
Conditions
Interventions
None listed
Sponsors
Madhusudan Healthcare
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 75 years old of either sex. 2. If rheumatoid arthritis is moderately or severely active, the disease activity during the screening period and the baseline period must meet the following criteria: Swollen joints count (SJC) >= 6 (based on 66 joint count) and tender joints count (Tender joints count: TJC) >= 6 (based on 68 joint count) (if the same joint has both swelling and Tenderness, this joint is included in the counts of swollen joints and tender joints). 3. Morning stiffness in and around the joints for at least 6 weeks which is lasting at least 1 hr before the maximal improvement. 4. Take medically approved non-drug contraceptive measures (such as drug-free intrauterine devices, condoms, female sterilization, and male sterilization) during the entire trial period and at least 3 months after the end of the medication, and no Pregnancy planner. 5. Those who understand, voluntarily sign the informed consent form, and comply with the requirements of the research plan.
Exclusion criteria
Exclusion criteria: 1. Those who have received any medical supportive treatments (such as whitening drugs, drugs for anaemia (except folic acid), liver-protecting and enzyme-lowering drugs, blood transfusions, etc.) within 2 weeks before screening. 2. Patients with acute myocardial infarction, unstable angina pectoris, stroke, and cardiac insufficiency within 6 months before screening. 3. The kidney, lung, digestive tract, nervous system and other serious diseased individuals (such as: poorly controlled severe diabetes, hypertension, interstitial pneumonia, obstructive Lung disease, bronchospasm, etc.), the investigator judged that it is not suitable to join the research. 4. Those who have a history of smoking, alcoholism, or drug abuse within 12 months before screening. 5. People with other primary or secondary immunodeficiencies in the past or at the time of screening, including patients with a history of HIV infection and positive HIV test results. 6. Patients administering any herbal or topical herbal pain relief agents. 7. The patients with current or recent corticosteroid treatment; or ongoing treatment with anticoagulants, hydantoin, lithium, steroids, methotrexate and colchicines or concurrent pain relieving medication such as antipyretics, analgesics, tranquilizers, hypnotic, excessive alcohol, NSAIDs. 8. Those who have participated in other clinical studies within 3 months before screening. 9. Women who are preparing for pregnancy, pregnancy, lactation, or who become pregnant during the planned trial period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the percentage of patients achieving a 20% of ACR response rate SECONDARY OUTCOME Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| . To estimate the change in DAS 28 score, VAS scoresand HAQ disability index (HAQDI) from baseline. 2. Change in the acute phase reactants ESR (mm/hr) and CRP (mg/L) which are unspecific and sensitive markers of the inflammatory process. 3. To evaluate the biochemical parameters (Anti-CCP, CRP, ESR, RA-Factor), digitalized X ray (for margin between knee joints ie gap between femur and tibia to be measured at three points for cartilage damage and recovery) on the basis of the physical examination done by an orthopedist before the treatment and after the treatment and after the completion of the study to compare for any changes (if any). Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactGagan Goswami
Pharexcel Consulting Private Limited
Outcome results
None listed