A Clinical study to evaluate efficacy and safety of Ostofix Tablet in subjects suffering from Osteoarthritis of Knee(s)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To assess efficacy of Ostofix Tablet in subjects suffering from Osteoarthritis of Knee by assessing
研究概览
简要总结
The present study will be conducted in India after IEC approval. Diagnosis of OA of knee will be confirmed byradiographs and diagnosed according to ACR diagnostic criteria. Subject will then undergo investigationsi.e. fasting blood sugar, CBC, ESR, Hb%, Liver function tests, Renal functiontests, Lipid profile, Urine routine and microscopic, Urine pregnancy test (onlyif the subject is female of child bearing potential), HIV test [every patient(for screening) will be sent to ICTC of Saneguruji Aarogya Kendra for preinvestigation counseling. The consent form will also be signed at ICTC and thephotocopy of the same will be enclosed in the CRF] and ECG.
A wash out period of 7 days will begiven. During washout period and the whole study period (viz. 90 days + 7days), subject will be advised to refrain from NSAID’S or any other local orsystemic analgesics and steroids, except tab Paracetamol (up to 2 gm/day incase of severe joint pain) or any standard analgesic drug. Also subject will beadvised to refrain from any Ayurvedic, Homeopathy, Unani, Siddha Medicine, andNutraceutical and food supplements for OA of Knee.
On baseline visit (Day 0),subjects will be recruited if he/she meets all the inclusion criteria. Subjectswill then undergo general and systemic examinations. Subject’s baseline kneejoint(s) pain will be assessed on Visual Analogue Scale (VAS), subjects jointpain subscore, stiffness subscore and physical function subscore will beassessed on WOMAC Index. The knee(s) will be evaluated for soft tissueswelling/synovitis (grade: 0= None, 1= Mild, 2=Moderate, 3=Severe.) All thesubjects will be evaluated for their quality of life on SF -36questionnaires. Subjects will be askedto walk 50 feet on flat surface and the time required to walk 50 feet and distance between feet while walking 50 feeton even surface will be recorded in the CRF.
Subjects will be given 1 HDPEcontainer (60 tablets) of Ostofix Tablet. All the subjects will be advised totake 2 tablets of given Ostofix twice daily orally after meals for 90 days. Afterthe baseline visit, subjects will be called for follow up visits on 15thday, 30th day, 45th day, 60th day, 75thday and 90th day
On every follow up visitexcept last follow up visit, subjects will be provided with study medicine. Onevery follow up visit, the empty container will be collected from the subjectand drug compliance will be checked.
During study period, subjects will beallowed to take tab Paracetamol up to 2 gm/day or any standard analgesic drug incase of severe joint pain. The use of Paracetamol or any standard analgesicdrug as a rescue medicine will be recorded in the CRF.
On every follow up visit,subjects will undergo general and systemic examinations. The Knee joint(s) painwill be assessed on Visual Analogue Scale (VAS). Subject’s knee joint(s) pain subscore,stiffness subscore and physical function subscore will be assessed on WOMACIndex. The knee(s) will be evaluated for soft tissue swelling/synovitis.Patient’s global evaluation and Investigator’s global evaluation for overallimprovement will be done on last follow up visit. On day 30, day 60 and day 90,all the subjects will be evaluated for their quality of life on SF -36questionnaires. Subjects will be asked to walk 50 feet on flat surface and thetime required to walk 50 feet and distancebetween feet while walking 50 feet on even surface will be recorded inthe CRF. Tolerability of the trial medicineswill be assessed by the investigator and by the subject at the end of study.All the subjects will be closely monitored for any adverse events/ adverse drugreactions.
On final follow up visit (i.e. Day 90),subject’s laboratory investigations (viz. CBC, ESR, Hb%, Liver function tests,Renal function tests, Lipid profile, Urine routine & microscopic) will beperformed. After completion of 90 days of studytreatment, all the subjects will be asked to stop trial medications and takeadvice of investigator for further treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Symptoms of osteoarthritis in one or both knee joints for a minimum of six months and maximum for five years •History of knee pain due to osteoarthritis requiring the use of NSAIDs Acetaminophen or another analgesic agent on a regular basis greater than or equal to three days per week for at least six months before the screening visit •OA confirmed by radiographs and diagnosed according to ACR diagnostic Criteria clinical and radiological •Subjects may take tab paracetamol greater than or equal to 2g per day or any standard analgesic drug for breakthrough pain •Subjects not having knee joint deformity •Subjects signing written informed consent and ready to comply with the protocol requirements •Subjects with pain VAS greater than 40 mm on weight bearing activities.
排除标准
- •â€¢Rheumatoid arthritis, gout pseudo gout inflammatory arthritis Pagets disease of bone chronic pain syndrome fibromyalgia or another major joint disease •History of surgery including arthroscopy or major trauma to the study joint in the previous six months before the screening visit •Subjects requiring knee arthroplasty within 6 months of screening or anticipating any need for a surgical procedure on the index joint during the study •Signs of clinically important active inflammation of the study knee joint including redness warmth and or a large bulging effusion with the loss of normal contour at the screening and or baseline visits •Use of systemic corticosteroids within 2 months of screening or intra-articular viscosupplementation within the past 3 months •Use of any other investigational drug within 1 month prior to randomization •Subjects having diabetes mellitus tuberculosis HIV Ischemic Heart Disease •Known other major medical or surgical disease •Pregnancy and Lactation.
- •â€¢Known hypersensitivity to ingredients used in study drug.
结局指标
主要结局
To assess efficacy of Ostofix Tablet in subjects suffering from Osteoarthritis of Knee by assessing
时间窗: Day 0 day 15 day 30 day 45 day 60 day 75 day | 90 | 1 Knee Joint Pain on VAS | 2 WOMAC Index
1 Knee Joint Pain on VAS
时间窗: Day 0 day 15 day 30 day 45 day 60 day 75 day | 90 | 1 Knee Joint Pain on VAS | 2 WOMAC Index
2 WOMAC Index
时间窗: Day 0 day 15 day 30 day 45 day 60 day 75 day | 90 | 1 Knee Joint Pain on VAS | 2 WOMAC Index
次要结局
- 1) Quality of life on SF -36 questionnaire 2) Assessment of time to walk 50 feet and distance between feet while walking 50 feet on even surface 3) Global assessment for overall improvement by the subject and by patient 4) Assessment of use of Tab Paracetamol or any standard analgesic drug as rescue medicine. 5) Assessment of Tolerability of the study drug 6) Assessment of safety laboratory investigations