CTRI/2008/091/000063已完成3 期
A Phase III equivalence drug trial for evaluation of efficacy and safety of SGPF â??Câ?? (an oral standardized herbal preparation) and SGPF â??Câ?? plus (with Guggul) in patients with symptomatic Osteoarthritis Knees: A randomized, double blind comparison with Oral Celecoxib and Glucosamine.
CSIR0 个研究点目标入组 440 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 440
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, 40 to 70 years of age.
- •2.Diagnosis of OA knees , based on typical history, clinical presentation, classical radiological findings and fulfilling the ACR classification criteria for OA knees
- •3Presence of typical osteophytes on skiagram knee is mandatory
- •4.A minimum pain VAS score > 4 on walking in one or both knees during the 24 hours preceding recruitment.
- •5.Patient ambulant and requiring treatment with an anti- inflammatory drug and not receiving regular anti â?? inflammatory or analgesic drugs, or are not satisfied with drugs being taken and seek a change.
- •6.Willing to come for regular follow â?? up visits.
- •7.Written Informed Consent from the patient.
排除标准
- •1.Known history of hypersensitivity or intolerance to NSAIDs, aspirin, COX-2 inhibitors, NSAIDs and any other analgesic medicine.
- •2.Pregnant women, lactating women and women of child bearing potential not following adequate contraceptive measure.
- •3.Patients with known contraindication to Shunthi, Guduchi, Amalaki and Guggul formulation
- •4.Non degenerative joint diseases or other joint diseases which will interfere with the evaluation of OA.
- •5.Patients incapacitated or bound to wheel chair or bed and unable to carry out self care activities.
- •6.Treatment with intra-articular injection of corticosteroids into the knee within 3 months preceding the study.
- •7.Pre-existing or recent onset of demyelinating disorders or type I diabetes
- •8.Ongoing treatment with anticoagulants, hydantoin, lithium, steroids, methotrexate and colchicine.
- •9.Presence or history of active peptic ulcer in the preceding 6 months or bleeding ulcer at anytime in the past.
- •10.Evidence of severe renal, hepatic or hemopoietic disease or severe cardiac insufficiency as revealed by laboratory investigations or other tests.
- •11.Patient with congestive heart failure
- •12.All patients with Hypertension and IHD will be excluded. All patients with severe and/or uncontrolled Hypertension. (Appendix C)
- •13.Patients of IHD diagnosed as per conventional clinical and routine investigations in standard care practice will be excluded. Patients with ECG abnormalities suggestive of IHD will be excluded.
- •14.Clinically significant untreated hyperlipidemia in context of a Cardiovascular risk. The normal range of the site laboratory will be used to interpret the lipid values. The significance of Hyperlipidemia will be decided by the Investigator based on the associated risk factors. (Appendix D)
- •15.History of having received any investigational drug in preceding one month.
- •16.Ayurvedic formulation or any form of CAM (Complimentary Alternative Medicine) therapy in the preceding 2 months
- •17.Concurrent pain relieving medication such as antipyretics, analgesics, tranquilizers, hypnotics, excessive alcohol, NSAIDs, (Paracetamol & Tramadol are permitted in extreme pain, see below for details) which would interfere with pain perception.
- •18.Unwilling to come for regular follow-up for the entire duration of the study.
- •19. Non â?? co-operative attitude of the patient.
- •20.Any condition (especially in particular with reference to Cardiovascular safety profile) that, in the opinion of the investigator, does not justify the
- •patientâ??s inclusion for the study.
研究者
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