Health Condition 1: M05- Rheumatoid arthritis with rheumatoid factor Health Condition 2: M057- Rheumatoid arthritis with rheumatoid factor without organ or systems involvement
Conditions
Interventions
Intervention1: Unani Compound Formulation: Unani Compound formulation contains Suranjan Talkh (Colchicum luteum Baker-Dried Corm-1 part), Zanjabeel (Zingiber officinale Rosc. Dried Rhizome- 1 part) an
Sponsors
Central Council for Research in Unani Medicine New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients irrespective of gender will be selected for the study. 2. Patients in the age group of 18 to 65 years fulfilling the criteria of the New American College of Rheumatology-European League Against Rheumatism 2010 for the diagnosis of rheumatoid arthritis. 3. Patients, who are ready to sign the informed consent, follow the protocol and willing to participate in the clinical study voluntarily. 4. Patients with features of preclinical rheumatoid arthritis, established rheumatoid arthritis and presence of active disease will be included in the study.
Exclusion criteria
Exclusion criteria: 1. Patients below 18 years and above 65 years of age. 2. Patients who fail to follow up. 3. Patients who fail to give written consent. 4. Women who are pregnant, planning pregnancy, or breast feeding. 5. Patients having other types of arthritis. 6. Patients with the history of any systemic illness like uncontrolled diabetes, malignant hypertension, cardiovascular diseases, severe blood disorders and impaired renal function or patient with any other severe chronic or acute disease interfering with attendance for therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity, Swollen joint count, Morning stiffness and Fatigue.The Data for these subjective parameters will be recorded on 0,7th,15th,30th and 45th day. Timepoint: 45 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| DAS 28 (Disease Activity Score), DAS 28-CRP, Erythrocyte Sedimentation Rate (ESR), Quantitative C -reactive protein (CRP), Quantitative Rheumatoid factor (RF) , Quantitative Anti-citrullinated protein antibody (ACPA/Anti-CCP),and Interleukin 6(IL-6).The data for these objective parameters including serum biomarkers will be recorded on 0th and 46th day of the study.The ECG, Haematological and Biochemical assessment will be done before and after the study in view of safety evaluation. The Data for remaining objective parameters i.e.Tender joint count and HAQ disability index score will be recorded on 0,7th,15th,30th and 45th day. Timepoint: 45 days | — |
Countries
India
Contacts
Public ContactDr Towseef Amin Rafeeqi
Regional Research Institute of Unani Medicine (RRIUM)
Outcome results
None listed