CTRI/2012/02/002416招募中2 期
Clinical Evaluation of Punarnava Guggulu, Dashmoola ghrita, and Kottamacukkadi Taila in the Management of Osteoarthritis. - ACT- OA-2010
Department of AYUSH Ministry of Health and 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 aged between 40 and 75 years.
- •2. Patients with Primary Osteoarthritis (Diagnosis to be confirmed by Kellgren Lawrence Radiological scale)
- •3. Pain in the affected joint(s) > six weeks.
- •4. Willing and able to participate in the study.
排除标准
- •1. History of any surgical /diagnostic intervention with reference to the affected joint(s).
- •2. Patients who are incapacitated, bedridden or confined to a wheelchair.
- •3. Patients with co morbidities such as gouty arthritis, rheumatoid arthritis and psoriatic arthritis
- •4. Patients having any deformity of knee, hip or back.
- •5. Patients with poorly controlled Hypertension ( >160/100 mm of Hg)
- •6. Patients with Diabetes Mellitus {B.S. (F) > 126 mg% and / or B.S. (2 hr. PP) >200 mg% or HbA1c > 6.5%}.
- •7. Patients with evidence of malignancy.
- •8. 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.
- •9. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome,
- •Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •10. Symptomatic patients with clinical evidence of Heart failure.
- •11. 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.
- •12. Alcoholics and/or drug abusers.
- •13. H/o hypersensitivity to any of the trial drugs or their ingredients.
- •14. Pregnant / lactating woman.
- •15. Patients who have completed participation in any other clinical trial during the past
- •six (06) months.
- •16. Any other condition which the Principal Investigator thinks may jeopardize the
研究者
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