A clinical study to see the effect of some Ayurvedic formulations in the management of Arthritis of small joints.

Phase 2

• Conditions: Health Condition 1: null- Rheumatoid Arthritis

• Registration Number: CTRI/2012/03/002534
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences CCRAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

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

a. Morning stiffness: Stiffness in and around joints lasting one hour before maximal improvement (More than 6 weekâ??s duration).

b. Arthritis of three or more joints, at least three joint area, observed by Physician, having pain with soft tissue swelling or joint effusion, not just bony over growth, (more than 6 weeks duration).

c. Arthritis of hand joints, at least 1 area in wrist and hand is swollen (more than 6 weeks duration).

d. Symmetric arthritis (more than 6 weekâ??s duration).

e. Presence of rheumatoid Nodules

f. Serum rheumatoid factor- positive

g. 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.

2. Patients Willing and able to participate in the study for 16 weeks.

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. Patients with poorly controlled Hypertension ( >160/100 mm of Hg)

5. Patients with Diabetes Mellitus {B.S. (F) > 126 mg% and / or B.S. (2 hr. PP)

>200 mg% OR HbA1c > 6.5%}

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

7. 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.

8. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome,

Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.

9. Symptomatic patients with clinical evidence of Heart failure.

10. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino

Transferase (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.

11. Alcoholics and/or drug abusers.

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

13. Pregnant / lactating woman.

14. Patients who have completed participation in any other clinical trial during

the past six (06) months.

15. Any other condition which the Principal Investigator thinks may jeopardize

the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified