CTRI/2014/08/004878已完成未知
An Open Labelled, Interventional, Single centric Clinical study to assess the Therapeutic Efficacy & Safety of Ossigen Capsules for the treatment of Knee Osteoarthritis
SG Phyto Pharma Pvt Ltd0 个研究点目标入组 36 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
- 入组人数
- 36
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
- •Male and Female (of and between 18 and 60 years of age) subjects suffering from Knee Osteoarthritis.
- •Be informed of the nature of the study and will give written informed consent.
- •Able to communicate well with the investigator, to understand and comply with the requirements of the study.
- •Patients who are suffering from Osteoarthritis
排除标准
- •Individuals who usually use an ambulation aid to walk such as a cane, crutch, walker or wheel chair.
- •Amputation of foot or previous major trauma to foot that would raise concerns about whether an insert might worsen foot pain. Persons with foot lesions such as sores or ulcers in which redistributing load in the foot might be dangerous, will be excluded.
- •Past history of deep venous thrombosis.
- •Pain emanating more from back or hip than from knee
- •Low pain score on WOMAC (less than or equal to 24)
- •Individuals who have received corticosteroid injections in the month prior to starting the trial. Individuals who had bilateral total knee replacements (TKR) or planning for TKR in next 6 months for affected knee.
- •Known other causes of arthritis including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), gout, psoriatic arthritis, pseudo gout.
- •Individuals with BMI > 30 kg/m2
- •Any disease or condition which might compromise the hematopoietic, renal, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- •History of autoimmune disorders â?? lupus erythematosis (SLE) or immunodeficiency diseases, including HIV.
- •Subjects using NSAIDS.
- •Presence of clinically significant abnormal laboratory results during screening.
- •Pregnancy or not using appropriate means of contraception
- •Use of any recreational drugs or a history of drug addiction.
- •Patient not willing to sign informed consent.
研究者
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