CLINICAL EVALUATION OF EFFICACY OF INDUKANTA GHRITA AND TRAYODASHANG GUGGULU IN THE TREATMENT OF RHEUMATOID ARTHRITIS

Phase 3

Completed

• Conditions: RHEUMATOID ARTHRITIS VIS –A–VIS AMAVATA

• Registration Number: CTRI/2018/07/015025
• Lead Sponsor: CCRAS

Brief Summary

The study is a open Clinical trial to evaluate the efficacy  and safety of Indukantha ghritha(10 gm twice daily) and Trayodashang Guggulu (3 gutika of 500mg )in management of Rheumatoid Arthritis vis a vis Amavata in 50 patients each at NARIP,Cheruthuruthy  and  CARIID, Kolkota.The total duration of study is 2 years and the intervention for 12 weeks.The primary outcome measure is the DAS-28 score.The secondary outcome measure will be Changes in Disability Index,ESR 7 CRP,,Global assessment of disease activity ,Pain VAS scale (at Baseline and on 15th,29th,43rd,57th and 71st day ),Questionnaire SF36(At baseline and 85th day).Clinical trial was completed. 50 subjects were enrolled. 48 subjects completed the trial and 2 subjects dropped out from study. Statistical analysis of the data & publication of clinical findings are remaining.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-26
• Last Update Posted: 2020-07-12

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients of either sex with age between 20 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: Stiffness in and around joints lasting one hour before Maximal improvement (More than 6 week duration).
• 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 week duration).
• Arthritis of hand joints, at least 1 area in wrist and hand is swollen (more than 6 week duration).
• Symmetric arthritis (more than 6 week duration).
• Presence of Rheumatoid Nodules f.
• Serum Rheumatoid factor- positive g.
• Typical radiographic changes of arthritis on PA view of hand & wrist r adiograph that must include erosions or unequivocal bony decalcification, localized in or adjacent to involved joints.
• 3. Adult onset 4 ) Duration of establish diseases > 2 years.
• 5. Patients willing to give written informed consent to participate in the study for 12 weeks.

Exclusion Criteria

• 1.Patients who have developed complications of Rheumatoid Arthritis e.g deformity of joints/bones, pleura pericardial diseases, 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 (140/90 mmHg) 5.Patients suffering with uncontrolled Diabetes mellitus (HBA1c > 6.5%) 6.Patients diagnosed with other arthritis like gouty arthritis, tuberculosis 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 past history of Atrial Fibrillation, Acute coronary syndrome, Myocardial infarction , stroke or severe arrhythmia in the last 6 months.
• 10.Patients with concurrent serious hepatic disorders (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 more than upper limit of normal >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 months 15.Any other condition which the Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in DAS-28 score	At Baseline, 15th day, 29th day, 43rd day, 57th day, and 71th day.

Secondary Outcome Measures

Name	Time	Method
Change in Disability Index (The Indian Health Assessment Questionnaire)	Change in acute phase reactants – ESR and CRP

Trial Locations

Locations (1)

National Ayurveda Research Institute for Panchakarma; 🇮🇳 Thrissur, KERALA, India

National Ayurveda Research Institute for Panchakarma

🇮🇳Thrissur, KERALA, India

Dr Remya E

Principal investigator

9447378133

drremyaenair@gmail.com