薄荷油和(艹贡)蒿子油的肠溶制剂给药后薄荷醇和香芹酮的药物动力学研究

患者服用薄荷油或蒿子油的肠溶制剂可避免因食管返流引起的不适。作者以随机、双交叉试验研究了健康志愿者口服薄荷油和蒿子油肠溶胶囊后薄荷醇和香芹酮的药物动力学,并与其速释制剂(对照组)的药物动力学进行了比较。每粒肠溶胶囊含90 mg 薄荷油和50mg 蒿子油,每粒速释胶囊含36 mg 薄荷油和20 mg 蒿子油。在禁食10 h 后,16名健康受试者1次服用2粒肠溶胶囊或5粒     

硫酸氨基葡萄糖胶囊治疗膝骨关节炎的疗效观察

目的：观察硫酸氨基葡萄糖胶囊治疗膝骨关节炎的疗效。方法：选择50例患有膝骨关节炎服用硫酸氨基葡萄糖胶囊2年的患者,每半年观察患者WOMAC骨关节炎指数和胫股关节内外侧关节间室的关节间隙的平均宽度变化。结果：服用硫酸氨基葡萄糖胶囊2年的患者在膝关节WOMAC骨性关节炎指数改善上疗效明显,膝胫股关节平均间隙基本无改变。结论：硫酸氨基葡萄糖在骨关节炎症状缓解和避免膝关节间隙狭窄方面疗效满意。     

复方甘草酸苷治疗斑秃疗效观察

目的:讨论复方甘草酸苷片(美能)治疗斑秃的疗效和安全性。方法:选择本院2008年8月～2010年8月斑秃患者64例,随机分为治疗组和对照组各32例。治疗组口服复方甘草酸苷片(商品名:美能,日本中复方甘草酸苷片发源制药公司生产)2片,每日3次,同时口服养血生发胶囊(佛山德众药业有限公司生产,每粒0.5g)4粒,每日2次口服,疗程2个月。对照组单用养血生发胶囊,用法及疗程同治疗组。两组治疗期间无外用药物,自己用梳子梳头刺激头皮,每日数次(3～4次)。治疗3个月后门诊随访判定疗效。两组疗程均为2个月,观察和记录患区毛发再生情况。结果:治疗组痊愈18例(56.25%),显效10例(31.50%),好转4例(12.50%),无效0例,总有效率为87.50%;对照组痊愈12例(37.50%),显效8例(25.00%),好转10例(31.50%),无效2例(6.25%),总有效率为62.50%。结论:复方甘草酸苷片联合养血生发胶囊治疗斑秃,疗效较好。     

氨基葡萄糖胶囊治疗骨性关节炎的临床疗效观察

目的探讨氨基葡萄糖胶囊在治疗骨性关节炎中的疗效及安全性。方法已被确诊为骨性关节炎的患者134例,随机分为两组,对照组服用芬必得0.3g,每日2次。试验组服用氨基葡萄糖胶囊0.75g,每日2次。以上两组患者分别记录患者的临床效果及不良反应。共观察6周。结果 6周后,两组在日常运动量、饮食等条件基本相同的情况下,实验组的疗效明显优于对照组,而不良反应却明显降低。结论氨基葡萄糖胶囊在治疗骨性关节炎中的疗效及安全性。     

盐酸氨基葡萄糖治疗骨关节炎的临床观察

目的观察盐酸氨基葡萄糖治疗膝骨关节炎的疗效。方法将65例膝骨关节炎患者随机分为两组,治疗组（35例）用盐酸氨基葡萄糖,口服,3次/d,2粒/次。对照组（30例）用布洛芬缓释胶囊,口服,2次/d,1粒/次。两组疗程均为4周。结果治疗组总有效率（91.4%）明显高于对照组（83.3%）（P〈0.05）。结论盐酸氨基葡萄糖能有效治疗膝骨关节炎。     

抗骨增生片联合骨肽片治疗骨质增生症60例

目的 观察抗骨增生片联合骨肽片治疗骨质增生症的疗效.方法 将120例骨质增生症患者随机均分为治疗组和对照组,治疗组60例口服抗骨质增生片4片和骨肽片2片、每日2次,对照组60例口服骨增消胶囊6粒、每日3次,均以30 d为1个疗程,共治疗4个疗程.结果 治疗组治愈率30.00%,明显高于对照组的8.33%(P<0.01).结论 抗骨增生片联合骨肽片治疗骨质增生症,疗效明显,值得推广.     

复方盐酸氨基葡萄糖治疗骨关节炎的多中心随机双盲试验

目的:观察并验证复方盐酸氨基葡萄糖胶囊和片剂治疗骨关节炎的疗效及安全性。方法:360例骨关节炎病人采用多中心、随机、双盲的研究方法,分为胶囊剂、片剂及安慰剂3组,按照1:1:1的对照原则,每组120例。分别口服复方盐酸氨基葡萄糖胶囊、片剂和安慰剂,每次3粒,每日3次,连续服用3 mo,随访并观察其临床疗效及不良反应。结果:胶囊剂组与片剂组治疗骨关节炎总有效率为92．5％及93．3％,病人生活质量明显提高,临床上2组间疗效比较无显著差异(P>0．05)。安慰剂组有效率为20．8％,与试验组比较有显著差异(P<0．05)。胶囊剂组和片剂组的不良反应发生率分别为0．8％和3．3％,差异无显著意义(P>0．05)。结论:复方盐酸氨基葡萄糖胶囊和片剂治疗骨关节炎疗效好,安全性高。     

简述骨关节炎特异性药物治疗的前景

目的探索骨关节炎（OA）特异性药物治疗的优势。方法近几年来临床开辟了用氨基葡萄糖、硫酸软骨素片口服治疗骨关节炎的新途径。结果特异性药物治疗（包括氨基葡萄糖、硫酸软骨素、双醋瑞因等）通过各种措施减轻疼痛和改善关节功能,延缓或阻断骨关节炎的关节结构改变,可成为治疗OA的病情改善药。结论众多基础及临床试验均表明,氨基葡萄糖、硫酸软骨素可缓解OA的关节症状,还可具备软骨保护和修复作用,且这两种药物的疗效维持时间也较长。     

八珍胶囊治疗气血两虚证临床疗效观察

目的 观察八珍胶囊治疗气血两虚证的临床疗效.方法 将153名气血两虚患者以2:1抽签方式随机分为观察组(102例)和对照组(51例),观察组患者服八珍胶囊(每次3粒,每日2次每粒含量0.4g),对照组患者服用八珍丸(每次6g,每日2次)用药时间20天.采用单盲法观察治疗前后全部患者的气血两虚证候及贫血患者的血象,慢性缺血性心脏病患者的zx休息时心电图等变化情况,放免法测定免疫球蛋白水平.结果 症候疗效结果 显示,八珍胶囊组总有效率为9 3.1%,心电图总有效率为62.9%,优于八珍丸组(P＜0.0 5);八珍胶囊在升高患者Hb水平上也比八珍丸组好.结论 八珍胶囊治疗气血两虚证比八珍丸具有更佳的效果.     

乌灵胶囊治疗老年失眠症

目的：观察乌灵胶囊对老年失眠的影响。方法：56例老年失眠症病人随机分为乌灵、枣仁2组。乌灵组36例,其中男性20例,女性16例,口服乌灵胶囊(每粒装乌灵菌粉0.33 g),每次3粒,每日3次,共服用1 mo。枣仁组20例,男性11例,女性9例,口服复方枣仁胶囊(每粒装0.4 g),每日睡前服1粒,共服用1 mo。观察治疗后总有效率、入睡困难分值、夜醒次数和实际睡眠时间的变化。结果：枣仁组、乌灵组治疗老年失眠症临床总有效率分别为75%和86%。与治疗前比较,枣仁组、乌灵组均能够降低入睡困难分值,延长实际睡眠时间,差异有非常显著和显著意义(P＜0.01,P＜0.05)。治疗后2组间比较,降低入睡困难分值,以枣仁组优于乌灵组,差异有非常显著意义(P＜0.01)；延长实际睡眠时间和减少夜醒次数则以乌灵组为佳,差异有显著和非常显著意义(P＜0.05,P＜0.01)。结论：乌灵胶囊与复方枣仁胶囊均有较好的安神催眠作用,乌灵胶囊在减少夜醒次数和延长实际睡眠时间方面具有明显的优势。     

Efficacy and safety of low-dose SoluMatrix meloxicam in the treatment of osteoarthritis pain: a 12-week,phase 3 study

Objective:

Nonsteroidal anti-inflammatory drugs (NSAIDs) such as meloxicam are commonly used to treat osteoarthritis (OA) but are associated with potentially serious dose-related adverse events (AEs). SoluMatrix meloxicam has been developed with the goal of enabling effective treatment at low doses. This phase 3 study evaluated the efficacy and safety of low-dose SoluMatrix meloxicam capsules 5?mg and 10?mg administered once daily for 12 weeks in patients with OA-related pain.

Research design and methods:

This randomized, double-blind study enrolled patients ≥40 years of age with confirmed hip or knee OA (Kellgren–Lawrence grade II–III) who were chronic users of NSAIDs and/or acetaminophen for OA pain and had Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale mean scores ≥40?mm. Eligible patients experienced an OA pain flare (defined as a ≥15?mm increase in the WOMAC pain subscale score) following discontinuation of NSAIDs/acetaminophen. Patients were randomized to receive once-daily SoluMatrix meloxicam 5?mg or 10?mg, or placebo for 12 weeks.

ClinicalTrials.gov identifier: NCT01787188.

Main outcome measures:

The primary outcome measure was the mean change from baseline in WOMAC pain subscale score at week 12.

Results:

Low-dose SoluMatrix meloxicam 5?mg (?36.52 [2.49]; P?=?0.0005) and 10?mg (?34.41 [2.68]; P?=?0.0059) once-daily treatment significantly reduced the mean (standard error) WOMAC pain subscale score from baseline at week 12 compared with placebo (?25.68 [2.64]). Patients treated with SoluMatrix meloxicam 5?mg or 10?mg reported significantly greater improvements in total WOMAC score and in WOMAC stiffness and function subscale scores at 12 weeks compared with placebo. The most common AEs in the combined low-dose SoluMatrix meloxicam group were headache, diarrhea, nausea, osteoarthritis, and urinary tract infection.

Conclusions:

Low-dose SoluMatrix meloxicam may have a potential role as a new therapeutic option for the management of OA-related pain.     

Efficacy and tolerability profile of etoricoxib in patients with osteoarthritis: A randomized,double-blind,placebo and active-comparator controlled 12-week efficacy trial

OBJECTIVE: To evaluate the efficacy of 12 weeks of treatment with etoricoxib, a selective COX-2 inhibitor, in patients with osteoarthritis (OA) of the knee or hip. METHODS: In the 12-week placebo- and active comparator-controlled period of a randomized, double-blind study, eligible patients were treated with etoricoxib 60 mg once daily (n = 224), naproxen 500 mg twice daily (n = 221), or placebo (n = 56). Western Ontario McMaster's Osteoarthritis Index (WOMAC) pain and physical function subscales and patient's global assessment of disease status were primary end points. Key secondary and other end points were patient's and investigator's global assessment of response to therapy, WOMAC stiffness subscale, investigator's global assessment of disease status, rescue paracetamol use, proportion of patients discontinuing due to lack of efficacy, and study joint tenderness. RESULTS: Etoricoxib 60 mg demonstrated efficacy significantly superior to placebo (p < or = 0.005) and comparable to naproxen 500 mg twice daily as assessed by the primary efficacy end points. Secondary and other end points confirmed these results. Treatment effects were evident by day 2, maximal by week 2, and sustained over the entire 12 weeks. Etoricoxib was well tolerated for 12 weeks. CONCLUSIONS: Etoricoxib showed rapid and durable treatment effects in patients with OA of the knee or hip. Etoricoxib was generally well tolerated.     

An open-label study of a second course of hylan G-F 20 for the treatment of pain associated with knee osteoarthritis

OBJECTIVE: To evaluate the efficacy and tolerability of a second course of hylan G-F 20 for the treatment of osteoarthritic knee pain in patients who experienced a clinical benefit with an initial course of therapy. RESEARCH DESIGN AND METHODS: In this prospective, open-label study, men or women (>/=40 years of age) with knee osteoarthritis (OA) received three weekly injections of hylan G-F 20. Consecutive patients who requested a second course of hylan G-F 20 therapy due to OA knee pain subsequent to pain relief with a first course of therapy were enrolled between October 26, 2000 and January 18, 2001. MAIN OUTCOME MEASURES: Pain while walking on a flat surface (Western Ontario and McMaster's Universities Osteoarthritis Index, WOMAC, question A1), WOMAC domain C (physical functioning), full WOMAC, and patient and investigator overall visual analog scales (VAS). Efficacy variables were measured at baseline and at weeks 1, 2, 4, 8, 12 and 26. An analgesic washout was required before all efficacy evaluations. RESULTS: Patients receiving at least one injection of hylan G-F 20 (n = 71) were predominantly Caucasian (84.5%) and female (64.8%), with a mean age of 65.5 years and mean weight of 200.1 pounds. The mean time between the first and second courses of hylan G-F 20 was 19.6 months (median 17.6 months). With hylan G-F 20, pain while walking on a flat surface was significantly lower (p < 0.001) than baseline at all time points up to week 26 (mean +/- SEM: -1.40 +/- 0.10 at week 26). Actual scores decreased from 2.4 +/- 0.10 at baseline to 0.97 +/- 0.11 at week 26. Scores for the WOMAC domain C, full WOMAC and patient and investigator overall VAS also significantly improved (p < 0.001) at all time points. A second course of hylan G-F 20 was generally well-tolerated, based on the low incidence of local adverse events (AEs) - only one patient (1.4%) experienced a severe event, the types of AEs, and the fact that no patients discontinued the study due to these AEs. The types of related AEs observed were not qualitatively different from those listed in the current product information and published literature. CONCLUSION: A second course of hylan G-F 20 therapy is an appropriate therapy for the treatment of OA knee pain in patients who had a previous favorable clinical response. For continued relief of osteoarthritis knee pain, this study supports repeat use of hylan G-F 20 in these patients.     

尼美舒利治疗类风湿关节炎和骨性关节炎的临床研究

目的：观察国产尼美舒利对类风湿关节炎（ＲＡ）和骨性关节炎（ＯＡ）的疗效和安全性。方法：选取ＲＡ患者５９ 例和ＯＡ患者４４ 例。ｐｏ 尼美舒利片１００ ｍｇ,ｂｉｄ;对照组ｐｏ 布洛芬缓释胶囊３００ｍｇ,ｂｉｄ。治疗时间为４ｗｋ。分别观察治疗前后临床指标和炎性实验指标的变化。结果：尼美舒利治疗ＲＡ４ｗｋ 后,疼痛程度、压痛关节数、关节压痛指数、关节肿胀指数、握力、晨僵时间、血沉均显著改善。对ＲＡ的总有效率为８３．３％ 。治疗ＯＡ４ｗｋ 后,膝关节活动痛、１５ｍ 行走时间、日常活动能力及病人综合评估均有显著改善。对ＯＡ的总有效率为７５．０％ 。其不良反应总发生率为１９．２％ , 以胃肠道反应为常见（９．６％）。尼美舒利对ＲＡ和ＯＡ的疗效及不良反应的发生率与布洛芬相比均无显著性差异。结论：尼美舒利对ＲＡ和ＯＡ的疗效及不良反应的发生率均与布洛芬相当。     

魏氏三辨取穴针灸治疗膝骨性关节炎临床研究

目的：评价魏氏三辨取穴针灸治疗膝骨性关节炎的临床疗效。方法将膝骨性关节炎患者60例随机分为2组,针灸组30例用魏氏三辨取穴针灸治疗;西药组30例口服双氯芬酸钠双释放肠溶胶囊。分别在针灸治疗前、治疗5次、治疗10次、治疗20次后采用 WOMAC 问卷、VAS 评分、关节功能评分对患者进行评价,所有数据使用 SPSS 11．5统计软件进行统计学分析。结果两组患者治疗后 WOMAC 问卷、VAS 评分、关节功能评分积分均有显著改善,与治疗前比较差异均有显著性（P ＜0．01）;治疗后组间 WOMAC 问卷、VAS 评分比较,针灸组优于西药组,差异有显著性（P ＜0．05）,关节功能评分积分比较差异无显著性（P ＞0．05）。治疗后针灸组临床痊愈3例、显效16例、有效8例、无效3例;西药组临床痊愈2例、显效8例、有效17例、无效3例,针灸组综合疗效优于西药组（P ＜0．05）。结论魏氏三辨取穴针灸能有效改善膝骨性关节炎患者的疼痛、僵硬症状,改善膝关节功能不显著。     

微小RNA的辐射敏感性和生物标记作用的研究进展

目的 探讨复方玄驹胶囊联合双醋瑞因治疗膝骨性关节炎的临床疗效。方法 选取2019年5月—2021年4月在扬州大学医学院附属沭阳医院就诊的200例膝骨性关节炎患者作为研究对象,按照治疗方法将患者分为对照组和观察组,各100例。对照组口服双醋瑞因胶囊,50 mg/次,2次/d。观察组在对照组基础上口服复方玄驹胶囊,3粒/次,3次/d。患者连续治疗4周。观察两组的临床疗效,比较两组治疗前后的西安大略和麦马斯特大学骨关节炎指数（WOMAC）、膝关节的活动度评分（ROM）、膝关节功能评分（Lysholm）以及血清人类软骨寡聚蛋白（COMP）、基质金属蛋白酶-3（MMP-3）、白细胞介素-17（IL-17）水平。结果 治疗后,观察组的总有效率为91.00%,明显高于对照组的80.00%,差异有统计学意义（P<0.05）。治疗后,两组的疼痛、僵硬、日常生活评分、WOMAC总分显著降低（P<0.05）;治疗后,观察组的疼痛、僵硬、日常生活评分、WOMAC总分显著低于对照组,差异有统计学意义（P<0.05）。治疗后,两组ROM评分、Lysholm评分均显著升高（P<0.05）,且观察组ROM评分、Lysholm评分显著高于对照组（P<0.05）。治疗后,两组的COMP、MMP-3、IL-17水平均显著降低（P<0.05）;且观察组COMP、MMP-3和IL-17水平显著低于对照组,差异有统计学意义（P<0.05）。结论 复方玄驹胶囊联合双醋瑞因治疗膝骨性关节炎的疗效确切,可改善膝关节功能和活动度,控制病情,可能与调节炎症因子有关,安全性良好。     

Magnetic pulse treatment for knee osteoarthritis: a randomised, double-blind, placebo-controlled study

We assessed the efficacy and tolerability of low-frequency pulsed electromagnetic fields (PEMF) therapy in patients with clinically symptomatic knee osteoarthritis (OA) in a randomised, placebo-controlled, double-blind study of six weeks' duration. Patients with radiographic evidence and symptoms of OA (incompletely relieved by conventional treatments), according to the criteria of the American College of Rheumatology, were recruited from a single tertiary referral centre. 75 patients fulfilling the above criteria were randomised to receive active PEMF treatment by unipolar magnetic devices (Medicur) manufactured by Snowden Healthcare (Nottingham, UK) or placebo. Six patients failed to attend after the screening and were excluded from analysis. The primary outcome measure was reduction in overall pain assessed on a four-point Likert scale ranging from nil to severe. Secondary outcome measures included the WOMAC Osteoarthritis Index (Likert scale) and the EuroQol (Euro-Quality of Life, EQ-5D). Baseline assessments showed that the treatment groups were equally matched. Although there were no significant differences between active and sham treatment groups in respect of any outcome measure after treatment, paired analysis of the follow-up observations on each patient showed significant improvements in the actively treated group in the WOMAC global score (p = 0.018), WOMAC pain score (p = 0.065), WOMAC disability score (p = 0.019) and EuroQol score (p = 0.001) at study end compared to baseline. In contrast, there were no improvements in any variable in the placebo-treated group. There were no clinically relevant adverse effects attributable to active treatment. These results suggest that the Medicur unipolar magnetic devices are beneficial in reducing pain and disability in patients with knee OA resistant to conventional treatment in the absence of significant side-effects. Further studies using different types of magnetic devices, treatment protocols and patient populations are warranted to confirm the general efficacy of PEMF therapy in OA and other conditions.     

Overall tolerability and analgesic activity of intra-articular sodium hyaluronate in the treatment of knee osteoarthritis

OBJECTIVE: Viscosupplementation with intra-articular hyaluronic acid (HA) is an alternative to the treatment of symptomatic knee osteoarthritis (OA) with pain relieving drugs. Sinovial, is a sterile, non-pyrogenic 0.8% solution of highly purified sodium hyaluronate for intra-articular application. The aim of the present study was to investigate the safety and tolerability profile of this preparation in patients with symptomatic knee OA over 24 weeks. RESEARCH DESIGN AND METHODS: This was a single group, open-label study, including outpatients of both sexes, aged between 18 and 85 years, with symptomatic knee OA. All patients underwent weekly intra-articular injections of HA for 5 consecutive weeks and were followed-up for 19 additional weeks. The safety and tolerability profile (primary endpoint) was assessed by adverse event (AE) reporting. The secondary endpoint was efficacy evaluated by changes in the Western Ontario and McMaster Universities (WOMAC) score vs. baseline. Patient and physician satisfaction were also recorded. RESULTS: Intra-articular HA was generally well tolerated. The most frequent AE was pain at the injection site (5.8% of the injections); no serious treatment-related AE was reported. The WOMAC score was significantly reduced within the first 2 weeks of treatment (from 4.02 +/- 1.90 to 3.55 +/- 2.04, p = 0.0011), further decreased by the end of the injection series (week 6: 2.59 +/- 1.90; p < 0.0001) and maintained during the follow-up (week 24: 2.44 +/- 1.88; p < 0.0001). The WOMAC subscores were also significantly reduced from week 4 for 'pain' and from week 6 for 'stiffness' and 'physical function'. CONCLUSIONS: In the present study, intra-articular HA was well tolerated and safe in patients with symptomatic knee OA. Based on the sustained improvements in WOMAC score and subscores, a carry-over effect lasting for at least 19 weeks after the last injection may be proposed. These results further confirm the evidence of efficacy and safety of intra-articular HA in the management of knee OA.     

An open-label study of a second course of hylan G-F 20 for the treatment of pain associated with knee osteoarthritis

SUMMARY

Objective: To evaluate the efficacy and tolerability of a second course of hylan G-F 20 for the treatment of osteoarthritic knee pain in patients who experienced a clinical benefit with an initial course of therapy.

Research design and methods: In this prospective, open-label study, men or women (≥40 years of age) with knee osteoarthritis (OA) received three weekly injections of hylan G-F 20. Consecutive patients who requested a second course of hylan G-F 20 therapy due to OA knee pain subsequent to pain relief with a first course of therapy were enrolled between October 26, 2000 and January 18, 2001.

Main outcome measures: Pain while walking on a flat surface (Western Ontario and McMaster's Universities Osteoarthritis Index, WOMAC, question A1), WOMAC domain C (physical functioning), full WOMAC, and patient and investigator overall visual analog scales (VAS). Efficacy variables were measured at baseline and at weeks 1,2,4,8,12 and 26. An analgesic washout was required before all efficacy evaluations.

Results: Patients receiving at least one injection of hylan G-F 20 (n?=?71) were predominantly Caucasian (84.5%) and female (64.8%), with a mean age of 65.5 years and mean weight of 200.1 pounds. The mean time between the first and second courses of hylan G-F 20 was 19.6 months (median 17.6 months). With hylan G-F 20, pain while walking on a flat surface was significantly lower (p?<?0.001) than baseline at all time points up to week 26 (mean?±?SEM: ?1.40?±?0.10 at week 26). Actual scores decreased from 2.4?±?0.10 at baseline to 0.97?±?0.11 at week 26. Scores for the WOMAC domain C, full WOMAC and patient and investigator overall VAS also significantly improved (p?<?0.001) at all time points. A second course of hylan G-F 20 was generally well-tolerated, based on the low incidence of local adverse events (AEs) -only one patient (1.4%) experienced a severe event, the types of AEs, and the fact that no patients discontinued the study due to these AEs. The types of related AEs observed were not qualitatively different from those listed in the current product information and published literature.

Conclusion: A second course of hylan G-F 20 therapy is an appropriate therapy for the treatment of OA knee pain in patients who had a previous favorable clinical response. For continued relief of osteoarthritis knee pain, this study supports repeat use of hylan G-F 20 in these patients.     

Safety and efficacy of Curcuma longa extract in the treatment of painful knee osteoarthritis: a randomized placebo-controlled trial

Curcuma longa Linn. is widely used for the treatment of disorders associated with inflammation and was evaluated for its safety and efficacy in the treatment of painful knee osteoarthritis (OA). This was a randomized, single blind, placebo-controlled trial. Total of 120 patients (37 males and 83 females) with primary knee OA received either placebo (400 mg twice daily) or NR-INF-02 (500 mg twice daily) or glucosamine sulphate (GS) (750 mg twice daily) alone or combination of NR-INF-02 and GS for 42 days. The efficacy was assessed during treatment period, on day 21 and day 42. The decrease in severity of pain symptom and function of affected knee as primary efficacy outcome measure was assessed by Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale, respectively. The clinical examination of affected joint was measured by an orthopaedic specialist and using a Clinician Global Impression Change (CGIC) scale. The analysis of post-treatment scores following administration of NR-INF-02 using VAS, WOMAC, and CGIC at each clinical visit showed significant decrease (p < 0.05) compared to placebo. NR-INF-02 treated group showed a significant (p < 0.01) decrease in use of rescue medication, along with clinical and subjective improvement compared to placebo. The tolerability and acceptability profile of NR-INF-02 was better during the trial period. The study demonstrates safety and efficacy of NR-INF-02 as a useful treatment option for patients with primary painful knee OA.