A Single Center Open label, Randomized Controlled Pilot Clinical Study to Assess and Compare the Efficacy and Tolerability of a combination of Ostikot oral tablets (three 1 g tablets twice daily) and Rhukot Plus cream external application v/s Ostikot oral tablets (three 1 g tablets twice daily) and Rhukot Liniment external application v/s Ostikot tablet (three 1 g tablets twice daily) alone in Subjects with Osteo Arthritis of Knee over a period of 12 weeks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- The primary outcome with respect to the effectiveness on KOA will be the mean change in the global scale value of the Western Ontario and McMaster Osteoarthritis Index (WOMAC) from baseline to 12 weeks.
研究概览
简要总结
Thisis a randomized pilot, open labelled, prospective, single-center study toevaluate and compare the efficacy and safety of a combination of Ostikot oraltablets (three 1 g tablets twice daily) and Rhukot Plus cream v/s Ostikot oraltablets (three 1 g tablets twice daily) and Rhukot Liniment v/s Ostikot tablet alone(three 1 g tablets twice daily) in Subjects with Osteo Arthritis of Knee. All medicines used as Ayurvedic formulations prepared by Vaidyaratnam PS Varier’s Aryavaidyasala, Kottakkal. Ostikot tablets contain Alpinia galanga,Cassia fistula,Zingiber officinale,Tribulusterrestris,Ricinus communis,Boerhaavia diffusa and Commiphora mukul. Rhukot plus cream contains Azadirachta indica,Cedrus deodara,Menthaspecieses,Cinnamomum camphora and Gaultheria fragrantissima, Rhukot liniment contains Cedrus deodara,Azadirachtaindica,Camphora officinaram,Gaultheria fragrantissima and Mentha specieses. The clinical study is for a duration of 12 weeks for each subject and will recruit a total of 75 subject (25 in each group
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Diagnosed with idiopathic KOA according to the clinical guidelines of the American College of Rheumatology.
- •The guidelines include patients currently experiencing pain in one or both knees with at least 3 of the following 6 conditions: 1) aged 50 to 70 years, 2) morning stiffness within 30 minutes of waking, 3) crepitus, 4) bony tenderness, 5) bony enlargement, and 6) no palpable warmth.
- •2.VAS score during the most painful knee movement between 40-70 mm 3.Lequesne’s functional index score between 6-10 points 4.Patients ready to give written informed consent and willing to comply the study protocol.
排除标准
- •1.Inflammatory diseases, including rheumatoid arthritis 2.Cancer 3.Traumatic injury that might be related to the current knee pain 4.Autoimmune disease 5.Uncontrolled hypertension 6.Diabetes mellitus requiring insulin injection 7.Life-threatening cardiovascular or neurological events within the past year 8.Pregnant and lactating women 9.Chronic respiratory disease 10.Hemorrhagic disorder 11.Alcohol or drug addiction 12.Active infectious disease, including tuberculosis 13.Significant knee joint deformity 14.Knee replacement surgery for the affected knee 15.Knee arthroscopy within the past 2 years 16.Steroid injection in the knee joints within the past 3 months 17.Viscosupplement injections in the knee joints within the past 6 months 18.Joint fluid injection within the past 6 months 19.Acupuncture, Ayurvedic Therapy, or herbal medicine within the past 4 weeks.
结局指标
主要结局
The primary outcome with respect to the effectiveness on KOA will be the mean change in the global scale value of the Western Ontario and McMaster Osteoarthritis Index (WOMAC) from baseline to 12 weeks.
时间窗: Baseline week 2 week 4 week 6 week 8 week 10 week 12
次要结局
- 1.Change in VAS From Baseline to End of Treatment(2.Change in LFI from Baseline to End of Treatment)