CTRI/2019/12/022519已完成未知
An open label, single arm observational study to evaluate Solimo orthopaedic memory foam mattress relative influence on subjects with mild to chronic back pain on their sleep quality, activities of daily livingâ??.
Amazon Development Centre India Pvt Ltd0 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
- 未知
- 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
- Observational
入排标准
入选标准
- •1.Male and Female subjectsâ?? in general good health.
- •2.Subjects in the age group 18-60 years (both the ages inclusive).
- •3.Subjects willing to give a written informed consent and agree to come for a regular follow up visit.
- •4.Subjects willing to abide by and comply with the study protocol.
- •5.Subjects who have not participated in a similar investigation in the past four weeks.
- •6.Healthy volunteers with no known allergy to any of the test ingredients as established by medical history
排除标准
- •1.Known history of hypersensitivity or intolerance to NSAIDs, aspirin, COX-2 inhibitors, and any other analgesic medicine.
- •2.Pregnant women, lactating women and women of child bearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy test
- •3.Non degenerative joint diseases or other joint degenerative diseases (musculoskeletal disorders) which will interfere with the evaluation of bone and joint health (Rheumatoid arthritis, active gout, recent joint trauma (target joint), or joint infection)
- •4.Subjects incapacitated or bound to wheel chair or bed and unable to carry out self-care activities
- •5.Treatment with intra-articular injection of corticosteroids into the knee within 3 months preceding study.
- •6.Ongoing treatment with anticoagulants, hydantoin, lithium, steroids, methotrexate and colchicine
- •7.Presence or history of active peptic ulcer in the preceding 6 months or bleeding ulcer at any time in the past.
- •8.Evidence of several renal, hepatic or hemopoiic disease or severe cardiac insufficiency as revealed by laboratory investigations.
- •9.Subjects with congestive heart failure
- •10.Subjects with hypertension
- •11.Clinically significant untreated hyperlipidaemia in context of a cardiovascular risk
- •12.History of having received any investigational drug or participated in any other clinical trial which ended in preceding month or currently ongoing.
- •13.Concurrent pain relieving medication such as antipyretics, analgesic, tranquilizers, hypnotics, excessive alcohol, NSAIDs, (Paracetamol & Tramadol are permitted in extreme pain) which would interfere with pain perception
- •14.Non-co-operative attitude of the volunteer
- •15.Any condition that in the opinion of the investigator does not justify the volunteerâ??s inclusion for the study.
研究者
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