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CLINICAL TRIAL OF PUNARNAVA GUGGULU RASNA SAPTAKA KASHAYA ON RHEUMATOID ARTHRITIS (AMAVATA)

CLINICAL EVALUATION OF PUNARNAVA GUGGULU AND RASNA SAPTAKA KASHAYA IN THE MANAGEMENT OF RHEUMATOID ARTHRITIS

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/04/005691
Enrollment
60
Registered
2015-04-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Rheumatoid Arthritis (Amavata)

Interventions

Intervention1: 1. Punarnava Guggulu (Bhaishajya Ratnavali, Amavata Chikitsa,29.152-154) 2.Rasna saptaka Kashaya (Chakradatta, Amavata Chikitsa, Sloka 8): 1.Punarnava Guggulu (Bhaishajya Ratnaval Dose:

Sponsors

CENTRAL COUNCIL FOR RESEARCH IN AYURVDEDIC SCIENCES
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1). 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 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. 3).Patients willing and able to participate in the study for 14 weeks.

Exclusion criteria

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 poorly controlled Diabetes Mellitus ({B.S. (F) >126 mg/dl and /or B.S.(2 hr. PP) >200 mg/dl}. 6. Patients diagnosed with other arthritis like gouty arthritis, tuberculous arthritis etc. 7. Patients on prolonged ( > 6 weeks) medication with corticosteoids, antidepressants, anticholin- ergics, 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 Investigator thinks may jeopardize the study.

Design outcomes

Primary

MeasureTime frame
Changes in DAS-28 scoreTimepoint: 2.5 years

Secondary

MeasureTime frame
â?¢Change in Disability Index (The Indian Health Assessment Questionnaire) â?¢Change in acute phase reactants â?? ESR and CRP â?¢Change in Health Questionnaire SF-36 Timepoint: 2.5 years

Countries

India

Contacts

Public ContactDR SHRIPRAKASH

National Veterinary Ayurveda Research institute and Hospital

drsprakash.ayu@gmail.com9451865403

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026