A clinical study to evaluate efficacy and safety of AHPL/AYTAB/0313 in subjects suffering from osteoarthritis of knee(s)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Assessment of efficacy of AHPL/AYTAB/0313 tablet by assessing knee joint pain on VAS and by assessment of WOMAC Index
研究概览
简要总结
This study is an open label, interventional, single center, prospective clinical study to evaluate efficacy and safety of AHPL/AYTAB/0313 in subjects suffering from osteoarthritis of knee(s). The study will be conducted in 56 patients suffering from osteoarthritis of knee(s). The study will be conducted at Pune District Education Association’s, College of Ayurved & Research Centre and Hospital, Sector No. 25, Pradhikaran, Nigdi, Pune- 411 044, India. The primary outcome will be to evaluate the efficacy of AHPL/AYTAB/0313 by assessing knee joint pain on VAS and by assessing WOMAC Index score [on day -7, day 0, day 30, day 60, day 90, day 120, day 150 and day 180]. The secondary objectives will be to evaluate the efficacy of AHPL/AYTAB/0313 by assessing subject’s quality of life on SF-36 questionnaire, time required by subjects to walk 50 feet on even surface, knee joint swelling on graded scale, use of analgesic drug as rescue medicine [on day -7, day 0, day 30, day 60, day 90, day 120, day 150 and day 180]. The secondary objectives will be to evaluate the safety of AHPL/AYTAB/0313 by assessing laboratory investigations [on day -7 and day 180] and tolerability of the study drug with numbers of ADR [on day 180]. Also, clinical global evaluation for overall improvement by physician and by the patient will be assessed as secondary outcome on day 180.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subject willing to participate, who have read, understood and signed informed consent form 2.Subject with history of knee pain due to osteoarthritis requiring use of NSAIDs acetaminophen, or another analgesic agent on a regular basis (greater than or equal to 3 days per week) for at least 6 months before the screening visit.
- •3.OA confirmed by radiographs and diagnosed according to ACR diagnostic criteria (clinical and radiological) for the OA of the knee.
- •4.Subjects are willing to make all required study visits 5.Subjects are willing to follow study instructions given by the investigator.
排除标准
- •1.Subjects refused to give their informed consent 2.Subjects with rheumatoid arthritis, gout, pseudo gout, inflammatory arthritis, Pagets disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease 3.Subjects with history of surgery, including arthroscopy, or major trauma to the study joint in the previous six months before the screening visit 4.Subjects requiring knee arthroplasty within 6 months of screening or anticipating any need for a surgical procedure on the index joint during the study 5.Subjects with 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 6.Subjects using systemic corticosteroids within 2 months of screening, or intraarticular visco-supplementation within the past 3 months 7.Subjects with any other investigational drug within 1 month prior to randomization; 8.Subjects having diabetes mellitus, tuberculosis, HIV, ischemic heart disease 9.Subjects with known major medical or surgical disease 10.Pregnant and lactating women 11.Subjects with known hypersensitivity to ingredients used in study drug.
- •12.Subjects with significant abnormal laboratory parameters 13.ECG demonstrating any signs of uncontrolled arrhythmia and or acute ischemia.
结局指标
主要结局
Assessment of efficacy of AHPL/AYTAB/0313 tablet by assessing knee joint pain on VAS and by assessment of WOMAC Index
时间窗: Screening Visit (day -7), Baseline Visit (day 0), Visit 1 (day 30), Visit 2 (day 60), Visit 3 (day 90), Visit 4 (day 120), Visit 5 (day 150) and Visit 6 (day 180).
次要结局
- 1.Quality of life on SF -36 questionnaire(2.Time to walk 50 feet on even surface)