CTRI/2017/11/010340已完成1 期
Evaluation of the effect of Patrapinda sveda, Tailadhara externally and Panchatiktaka ksheera and ghruta internally in the management of Sandhivata (Osteo arthritis-knee)
Ministry of AYUSH Government of India0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 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 with age between 35 and 65 years
- •2.Patients of primary osteoarthritis knee
- •(Unilateral or bilateral with knee pain >= 14 mm on a 100 mm
- •visual analogue scale and at least 3 of following ACR clinical
- •category diagnostic criteria i.e.,
- •i) Crepitus on active motion
- •ii) less than 30 min of morning stiffness
- •iii) Joint tenderness
- •iv) Joint enlargement
- •v) No palpable warmth of synovium
- •3. Radiological changes as per Grade I- Grade III of
- •KELLGREN LAWRENCE Radiological scale
- •4.Able and willing to participate and to provide signed informed consent.
排除标准
- •1.Patient with Grade IV Kellgren & Lawrence Radiological scale.
- •2.History of trauma/ fractured joint/ surgical/ diagnostic intervention with reference to the affected joints
- •3.Patients with co- morbidities such as Gouty Arthritis, Rheumatoid Arthritis and Psoriatic Arthritis.
- •4.Patients having any deformity of knee, hip or back altering the gait and the posture of the patient.
- •5.Any unstable cardiovascular disease.
- •6.Patients who are not ready for IPD admission or for Panchakarma procedures.
- •7.Patients with ESR level above 35mm/hr
- •8.Patients with poorly controlled Hypertension ( >160/100 mmHg)
- •9.Patients with poorly controlled Diabetes Mellitus having HbA1C of > 6.5%
- •10.Patients on medication with corticosteroids, phototherapy, biologics, antidepressants 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.Symptomatic patient with clinical evidence of Heart failure.
- •13.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.
- •14.The Patient has been administered any chondroprotective drugs, intra articular injections into the affected joints or systemic medications with corticosteroids, during the preceding 3 months
- •15.Alcoholics and/or drug abusers
- •16.H/o hypersensitivity to any of the trial drugs or their ingredients
- •17.Pregnant/lactating woman.
- •18.Patients who have completed participation in any other clinical trial during the past six months.
- •19.Other conditions which are contraindicated for prescribed treatments.
- •20.Any other condition which the Investigator thinks may jeopardize the study.
研究者
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