Effect oF Ayurvedic Formulations and Fomentations in Rheumatoid arthritis wrt pain and stiffness of joints

Phase 2

• Conditions: Health Condition 1: null- Signs and Symptoms of Rheumatoid Arthritis

• Registration Number: CTRI/2017/11/010717
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-09-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 29

Inclusion Criteria

1.Patients of either sex with age between 30 and 60 years

2.Presence of any four out of the following seven criteria (according to 1987, revised criteria of American College of Rheumatology)

a.Morning stiffness

b.Arthritis of three or more joints, at least three joint areas, observed by

c.Physician, having pain with soft tissue swelling or joint effusion, not just bonyover growth.

d.Arthritis of hand joints, at least 1 area in wrist and hand is swollen.

e.Symmetric arthritis (more than 6 week duration).

f.Presence of Rheumatoid Nodules

g.Serum Rheumatoid factor- positive

h.Typical radiographic changes of arthritis on PA view of hand & wrist radiograph that must include erosions or unequivocal bony decalcification,localized in or adjacent to involved joints.

3.Willing to participate in the study and to give written informed consent.

Exclusion Criteria

1.Patients who have developed complications of Rheumatoid Arthritis e.g.deformity of joints / bones, pleura-pericardial disease, or else.

2.Patients who are unable to walk without support and / or confined to wheel chair.

3.Patients with structural deformity as the complication of RA.

4.Duration more than 10 years

5.Patients with poorly controlled Hypertension( >= 160/100 mmHg)

6.Patients suffering with Diabetes Mellitus (Blood Sugar Fasting > 126 mg/dl).

7.Patients diagnosed with other arthritis like gouty arthritis, tuberculous arthritis etc.

8.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.

9.Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome,Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.

10.Symptomatic patients with clinical evidence of Heart failure.

11.Patients with concurrent serious hepatic disorder (defined as Aspartate AminoTransferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin,Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dL), Severe Pulmonary Dysfunction(Uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease[COPD]), or any other condition that may jeopardize the study.

12.Alcoholics and/or drug abusers.

13.H/o hypersensitivity to any of the trial drugs or their ingredients.

14.Pregnant / lactating woman.

15.Patients who have completed participation in any other clinical trial during the past six months.

16.Any other condition which the Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified