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Role of Stifain tablet in the management of Rheumatoid arthritis

EVALUATION OF CLINICAL SAFETY & EFFICACY OF STIFAIN TABLET IN THE MANAGEMENT OF RHEUMATOID ARTHRITIS (AMAVATA)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/02/012142
Enrollment
60
Registered
2018-02-26
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

Interventions

Intervention1: stifain Tablet : Each tablet contains: 1. Maharasanadi Kvatha Formulation 150 mg 2. Yograj guggulu Formulation 100 mg 3. Mahavatvidhwans Ras Formulation 50 mg 4. Ekangvira Rasa Formula

Sponsors

Ayurchem Products Mumbai
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: CRITERIA FOR DIAGNOSIS:- Presence of any four out of the following seven (Joneâ??s) criteria (according to 1987, revised criteria of American College of Rheumatology) 4 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 scholar, 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. Patients fulfilling the diagnostic criteria, of either sex with age between 20 and 60 years (2) Willing and able to participate in the study.

Exclusion criteria

Exclusion criteria: 1) Patients who have developed complications of Rheumatoid Arthritis e.g. severe deformity of joints / bones, pleura-pericardial disease, or else. (2) Patients with poorly controlled Hypertension or with uncontrolled Diabetes Mellitus and having a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. (4) Patients on prolonged medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study. (5) H/o hypersensitivity to any of the trial drugs or their ingredients. (6) Pregnant/lactating women. (7) Patients having chronicity >10 years

Design outcomes

Primary

MeasureTime frame
To assess the clinical safety and efficacy of Stifain Tablet in the management of Rheumatoid Arthritis (Amavata) Timepoint: 2 months

Secondary

MeasureTime frame
To assess the improvement in physical mobility and quality of life in patientTimepoint: 2 months

Countries

India

Contacts

Public ContactDr Mandip Goyal

Institute for Post Graduate Teaching and Research in Ayurved, Jamnagar

mandipgoyal22@gmail.com09427572306

Outcome results

None listed

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