CTRI/2013/06/003751已完成4 期
A Multi-center, Prospective, Open-label, Randomized, Active-Controlled, Parallel-Group Clinical Study of Safety and Efficacy of Diclofenac Diethylamine Gel with Capsaicin, Methyl Salicylate and Menthol With Voveran® Thermagel� (Diclofenac Diethylamine Gel with Capsaicin, Methyl Salicylate and Menthol) In Painful Musculoskeletal Conditions.
Inventia Healthcare Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
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.Male or female patients aged 18 â?? 65 years (both inclusive).
- •2.Patients with mild to moderate pain and inflammation following acute blunt trauma of small and medium-sized joints and periarticular structures like sprains, strains, as well as tendinitis, bursitis, neck & shoulder pain, sciatica, muscle stiffness, joint pain and lumbago.
- •3.Patients with at least moderate pain of Visual Analogue Scale (VAS)greater or equal to 3.
- •4.Patient is able to provide written informed consent prior to study.
- •5.Willingness to comply with the study schedule and procedures.
排除标准
- •1.Patients with painful muscle spasms associated with musculoskeletal systems, which need parenteral therapy / surgery / hospital admission for management.
- •2.Patients with known history of severe osteoarthritis and rheumatoid arthritis.
- •3.Patients with active or recent history of inflammatory diseases of the gastrointestinal tract such as peptic ulcer, gastritis, regional enteritis, or ulcerative colitis.
- •4.History of aspirin-sensitive asthma, adverse reaction to oral nonsteroidal anti-inflammatory drug (NSAID), bleeding diathesis, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease or in the setting of coronary artery bypass graft surgery (CABGS).
- •5.Patients with uncontrolled hypertension(Diastolic blood pressure more than or equal to 110 mmHg and/or systolic blood pressure; more than or equal to 180 mmHg).
- •6.Patients with open wounds infected skin or other conditions of broken skin, skin affected by infection, inflammations at the site of proposed application.
- •7.Patients underlying dermatitis or dermatosis associated with the injury.
- •8.Use of any oral or topical analgesic or anti-inflammatory treatment within 1 week prior to study, or any other topical products, including topical medications, sunscreens, lotions, moisturizers, and cosmetics.
- •9.Known hypersensitivity to aspirin, diclofenac diethylamine or any other ingredient of product.
- •10.Any other acute or chronic illness that in the opinion of the investigator could compromise the integrity of study data or place the patient at risk by participating in the study.
- •11.Patient is a female who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period or breast feeding.
- •12.Participation in any other clinical trial during last 30 days.
研究者
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