CTRI/2018/03/012292已完成2 期
Clinical Evaluation of Rasnadi Kvatha Churna (Maha), Trayodashanga Guggulu and Brihatsaindhavadya Taila in the Management of Osteoarthritis of Knee (Janugata Sandhivata)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
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 aged between 35 and 65 years.
- •2)Patient with Primary Osteoarthritis (knee joints) fulfilling the diagnostic criteria of osteoarthritis recommended by the American College of Rheumatology. (ACR clinical classification criteria)
- •Knee pain and at least three of the following 6 criteria:
- •i.50 years of age or older
- •ii.Stiffness lasting less than 30 minutes
- •iii.Crepitus
- •iv.bony tenderness
- •v.bony enlargement
- •vi.no warmth to the touch
- •3)With radiological changes as per Grade I to III of Kellgren & Lawrence Radiological scale)
- •Kellgren & Lawrence Radiological scale
- •Grade 1: Narrowing is defined as doubtful narrowing of joint space and possible osteophytic lipping.
- •Grade 2: Osteophytes and definite narrowing of joint space.
- •Grade 3: Moderate multiple osteophytes, definite narrowing of joint space, some sclerosis and possible deformity of bone ends.
- •Grade 4: Large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone contour.
- •4) Willing and able to participate in the study for 16 weeks.
排除标准
- •1)Patients with Grade IV Kellgren & Lawrence Radiological scale.
- •2)History of any trauma / fractured joint / surgical / diagnostic intervention with reference to the affected joint(s).
- •3)Gross disability in performing daily normal routine i.e. bedridden patients or confined to a wheelchair.
- •4)Patients with co-morbidities such as gouty arthritis, rheumatoid arthritis and psoriatic arthritis.
- •5)Patients having any deformity of knee, hip or back altering the gait and posture of the patient.
- •6)Patients with uncontrolled hypertension ( >160/100 mm of Hg).
- •7)Patients with uncontrolled diabetes mellitus HbA1C > 7%
- •8)Patients with evidence of malignancy.
- •9)The patient has been administered any chondroprotective drugs, intra-articular injection into the affected joint.
- •10)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.
- •11)Patients who have a past history of atrial fibrillation, acute coronary syndrome, myocardial infarction, stroke or severe arrhythmia in the last 6 months.
- •12)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]).
- •13)Pregnant / lactating woman.
- •14)Patients who are currently participating in any other clinical trial.
- •15)Patients who have completed participation in any other clinical trial during the past six months
- •16)Any other condition which the Principal Investigator thinks may jeopardize the study.
研究者
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