Health Condition 1: M069- Rheumatoid arthritis, unspecified
Conditions
Interventions
None listed
Sponsors
Nil
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of age group 18 to 65 years irrespective of sex 2. Patients diagnosed with Rheumatoid arthritis (as per predefined ACR 2010 criteria) 3. Patients with Sama condition (sign & symptoms) of the disease (Amavata) 4. Patients willing to give written informed consent and willing to participate for a period of six weeks as per the protocol requirements
Exclusion criteria
Exclusion criteria: 1. Patients with complications of Rheumatoid Arthritis such as widespread inflammation, joint damage, cardio-vascular involvement etc 2. Patients who are unable to walk without support, or are confined to wheel chair or unable to participate in the study assessments due to impaired mobility. 3. Patients with poorly controlled Hypertension (�160/100 mmHg) or Diabetes Mellitus {HbA1C >8%). 4. Patients diagnosed with other types of arthritis like septic arthritis, gout, psoriatic arthritis, Rieters disease etc. 5. Patients on prolonged ( > 6 weeks) medication with corticosteroids, antidepressants, anticholinergics etc. or any other drugs that may have an influence on the outcome of the study. 6. Patients with unstable cardio-vascular disease. 7.Those with a history or presence of hepatic, renal, endocrine, neurological or pulmonary illness that in the opinion of the investigator may influence the study outcomes 8. Current use or history of use of alcohol or drugs or other habit forming substances such as smoking in the past 6 months 9.H/o hypersensitivity to any of the ingredients of the trial interventions 10.Pregnant women and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in DAS 28 ScoreTimepoint: baseline and 28th Day | — |
Secondary
| Measure | Time frame |
|---|---|
| Advent of any ADR/ADEs during treatment periodTimepoint: 14 th day and 28th Day;ââ?¬Â¢Change in Disability Index score (The Indian Health Assessment Questionnaire)Timepoint: baseline, 14 th day, 28th Day and 42nd day;ââ?¬Â¢Improvement in Agni (assessed through Patient self-assessment and physicianââ?¬â?¢s assessment)Timepoint: Baseline and 28th Day;ââ?¬Â¢To elicit Ama- utpattikar-bhava from detailed history of the participantsTimepoint: Baseline;Change in Ayurvedic disease specific parametersTimepoint: baseline, 14 th day, 28th Day and 42nd day | — |
Countries
India
Contacts
Public ContactChawla Deepa Nanakram
Central Council for Research in Ayurvedic Sciences
Outcome results
None listed