Comparative efficacy of Boswellia serrata extract and 5-Loxin® in the treatment of osteoarthritis of knee: a randomised, double-blind placebo-controlled clinical study

aila Impex (India)0 个研究点目标入组 75 人开始时间: 2008年10月9日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Participants must understand risks and benefits of the protocol and able to give informed consent
•2. Male and female subjects of 40-80 years of age
•3. Females of child bearing potential must agree to use an approved form of birth control and have a negative pregnancy test result
•4. Unilateral or bilateral OA of the knee for more than 3 months
•5. Visual Analogue Scale (VAS) score during the most painful knee movement between 40-70 mm after 7 day withdrawal of usual medication
•6. Lequesne's Functional Index (LFI) score greater than 7 points after 7 days of withdrawal of usual medication
•7. Ability to walk
•8. Availability for the duration of the entire study period

•1. History of underlying inflammatory arthropathy or severe rheumatoid arthritis (RA)
•2. Hyperuricemia (greater than 440 umol/L) and/or past history of gout
•3. Recent injury in the area affected by OA of the knee (past 4 months) and expectation of surgery in the next 4 months
•4. Intra-articular corticosteroid injections within the last 3 months
•5. Hypersensitivity to NSAIDs, abnormal liver or kidney function tests, history of peptic ulceration and upper gastrointestinal (GI) haemorrhage, congestive heart failure, hypertension, hyperkalemia
•6. Major abnormal findings on complete blood count, history of coagulopathies, haematological or neurological disorders
•7. High alcohol intake (greater than 2 standard drinks per day)
•8. Pregnant, breastfeeding or planning to become pregnant during the study
•9. Use of concomitant prohibited medication other than ibuprofen
•10. Obesity: Body Mass Index (BMI) more than 30

发起方

aila Impex (India)