CTRI/2010/091/000365已完成3 期
A Phase III, double blind, randomised, parallel design, controlled clinical study to evaluate the efficacy and safety of poly-herbal formulation "NARTANA" in patients with mild to moderate osteoarthritis of knees.
Nisarga Biotech PvtLtd2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2010年12月14日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Efficacy of poly-herbal formulation "Nartana" in comparison with Diclofenac
研究概览
简要总结
A Phase III, double blind, randomised, controlled clinical study is undertaken to evaluate the efficacy & safety of poly-herbal formulation "NARTANA" in 80 patients with mild to moderate oesteoarthritis of knees. The trial shall be conducted at two centres:1)Deenanath Mangeshkar Hospital & Research Centre, Pune & 2)Yogesh Hospital, Pune. The treatment will be given for 3 months. Diclofenac is used as a comparator (active controlled)drug. Efficacy of the drug will be evaluated based on visits on day (-7), 1, 15, 30, 45, 60, 75 & 90.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age above 40 years of either sex.
- •Diagnosis of OA in at least one knee joint (ACR classification for knee OA) confirmed by X ray.
- •Subject willing to come for regular follow up visits 4)Subject ready to give written informed consent.
排除标准
- •Patients who have very severe or doubtful OA diagnosis.
- •Subjects with severe co-morbidities, other known rheumatic conditions, congestive heart failure, Ischemic Heart Disease(IHD) and severe and or uncontrolled Hypertension3)The patients with current or recent corticosteroid treatment; or ongoing treatment with anticoagulants, hydantoin, lithium, steroids, methotrexate and colchicines or concurrent pain relieving medication such as antipyretics, analgesics, tranquilizers, hypnoties, excessive alcohol, NSAIDSs.4)Patients incapacitated or bound to wheel chair or bed and unable to carry out self care activities.5)History of active peptic ulcer, severe renal, hepatic or hemopoietic disease or severe cardiac insufficiency or undergoing artery bypass graft (CABG) surgery.6)Non degenerative joint diseases or other joint.7)Patient with history of known hypersensitivity to Diclofenac.8)Any condition that, in the opinion of the Investigator,does not justify the patient?s inclusion in the study.
结局指标
主要结局
Efficacy of poly-herbal formulation "Nartana" in comparison with Diclofenac
时间窗: at visit on day 1,45 & 90
次要结局
- Safety- Adverse events, serious adverse events, during the subject participation period of 90 days.(at visit on day 1,45 & 90)
研究者
研究点 (2)
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