CLINICAL EVALUATION OF A UNANI FORMULATION IN THE TREATMENT OF OSTEOARTHRITIS WITH SPECIAL REFERENCE TO EVALUATION OF ITS ANTIOXIDANT ACTIVITY

Central council for research in Unani medicine-CCRUM1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2010年8月17日最近更新: 2011年7月31日

适应症

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 60
试验地点: 1
主要终点: Clinical Parameters WOMAC Osteoarthritis Index Visual Analogue Scale (VAS) Active Range Of Motion (AROM)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is randomised double blinded,single centric to assess the safety & efficacy of Unani formulation in osteoarthritis in India.The primary outcome WOMAC osteoarthritis index, Visual analogue scale (VAS),Active range of motion (AROM).Secondary outcome measuresBiochemical Parameters. These parameters will be done before the treatment and after the completion of the study?Lipidperoxidation 27?Reduced glutathione 28?Superoxide dismutase 29?Catalase 30Radiological parametersX Rays of the affected joints will be taken before and after treatment to compare radiological changes (if any)

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant Blinded

入排标准

入选标准

•Aged between 40 to 70 yearsEither SexPatients diagnosed according to American College of Rheumatology Criteria for osteoarthritis of different joints will be selected Patients with symptoms consistent with osteoarthritis of the joint involved for at least six months prior to screening.Patients, who will be willing to discontinue all NSAIDs or other analgesic medication taken for any condition, will be included in the test group.Willingness to sign the informed consent, follow the protocol and participate in clinical trial voluntarily.

排除标准

•Pregnancy and LactationDiabetes mellitusRenal dysfunctionLiver diseases Gastrointestinal diseases(Peptic ulcer disease)Other types of arthritisIHD and hypertensionHistory of surgery of the joint involved Patients who will be unable to read/or understand the WOMAC questionnaire form.

结局指标

主要结局

Clinical Parameters WOMAC Osteoarthritis Index Visual Analogue Scale (VAS) Active Range Of Motion (AROM)

时间窗: 1

次要结局

hese Parameters Will Be Done Before The Treatment And After The Completion Of The Study Lipidperoxidation Reduced Glutathione Superoxide Dismutase Catalase Radiological Parameters X Rays Of The Affected Joints Will Be Taken Before And After Treatment To Compare Radiological Changes (If Any)(2)

研究者

发起方

Central council for research in Unani medicine-CCRUM

研究点 (1)

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