CTRI/2012/05/002661招募中2 期
Clinical Evaluation of Simhanaada Guggulu and Brihata Saindhavadi Taila in the Management of Rheumatoid Arthritis. - ACT- RA-2010
Department of AYUSH Ministry of Health Family Welfare Government of India0 个研究点目标入组 150 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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 16 weeks.
排除标准
- •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 corticosteoids, 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
研究者
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