Ramakanth G S H, Uday Kumar C, Kishan P V, Usharani P
Dept. of Clinical Pharmacology & Therapeutics, Nizam's Institute of Medical Sciences (NIMS), Hyderabad, India.
Dept. of Clinical Pharmacology & Therapeutics, Nizam's Institute of Medical Sciences (NIMS), Hyderabad, India.
J Ayurveda Integr Med. 2016 Jul-Sep;7(3):151-157. doi: 10.1016/j.jaim.2016.05.003. Epub 2016 Sep 16.
Root extracts of Withania somnifera (Ashwagandha) are known to possess analgesic, anti-inflammatory and chondroprotective effects. An aqueous extract of roots plus leaves of this plant has shown to yield higher percentages of withanolide glycosides and, accordingly, may possess better analgesic, anti-inflammatory and chondroprotective effects than root alone extracts.
To evaluate efficacy and tolerability of a standardized aqueous extract of roots plus leaves of W. somnifera in patients with knee joint pain and discomfort.
Sixty patients with knee joint pain and discomfort were randomized in a double-blind manner to W. somnifera 250 mg, W. somnifera 125 mg and placebo, all given twice daily. Assessment was done by Modified WOMAC, Knee Swelling Index (KSI), Visual Analogue Scale (VAS) at baseline and at the end of 4, 8, 12 weeks. Tolerability was assessed by incidence of adverse effects in treatment groups. Student's 't' test and ANOVA were used to compare mean change from baseline within and between the study groups. A p < 0.05 was considered significant.
At the end of 12 weeks, compared to baseline and placebo, significant reductions were observed in mean mWOMAC and KSI in W. somnifera 250 mg (p < 0.001), W. somnifera 125 mg (p < 0.05) groups. VAS scores for pain, stiffness and disability were significantly reduced in W. somnifera 250 mg (p < 0.001), W. somnifera 125 mg (p < 0.01) groups. W. somnifera 250 mg group showed earliest efficacy (at 4 weeks). All treatments were well tolerated.
Both the doses of an aqueous extract of W. somnifera produced significant reduction in outcome variables, with the 250 mg group showing significantly better response. In addition, the therapeutic response appears to be dose-dependent and free of any significant GI disturbances.
印度人参（睡茄）根提取物具有镇痛、抗炎和软骨保护作用。该植物根加叶的水提取物显示出更高百分比的睡茄内酯苷，因此可能比单独的根提取物具有更好的镇痛、抗炎和软骨保护作用。
评估标准化的印度人参根加叶水提取物对膝关节疼痛和不适患者的疗效和耐受性。
60例膝关节疼痛和不适患者以双盲方式随机分为250毫克印度人参组、125毫克印度人参组和安慰剂组，均每日服用两次。在基线以及第4、8、12周结束时，通过改良WOMAC量表、膝关节肿胀指数（KSI）、视觉模拟量表（VAS）进行评估。通过治疗组中不良反应的发生率评估耐受性。使用学生t检验和方差分析比较研究组内和组间相对于基线的平均变化。p < 0.05被认为具有统计学意义。
在12周结束时，与基线和安慰剂相比，250毫克印度人参组（p < 0.001）和125毫克印度人参组（p < 0.05）的平均改良WOMAC量表和KSI显著降低。250毫克印度人参组（p < 0.001）和125毫克印度人参组（p < 0.01）的疼痛、僵硬和残疾的VAS评分显著降低。250毫克印度人参组显示出最早的疗效（在4周时）。所有治疗耐受性良好。
印度人参水提取物的两个剂量均使结局变量显著降低，250毫克组显示出明显更好的反应。此外，治疗反应似乎呈剂量依赖性，且无任何明显的胃肠道干扰。
