A Double Blind Randomized Comparator Controlled Study to Assess the Effect of E-OA-07 (Lanconone) on Acute Pain Response in Subjects Suffering From Osteoarthritis of the Knee

The repetitive motions associated with active life and many sports can increase the wear and tear to the joints that leads to decrease in flexibility and joint pain finally heading its way to osteoarthritis. Activities such as jumping, running can wear away the cartilage that supports and cushions the joints of hands and knees, causing bones to rub against each other. Injuries stemming from repetitive motions can also cause and worsen the joint pain.
Joint pain is discomfort that arises from any joint . Irrespective of the underlying mechanisms, joint pain usually originates in activation of nociceptors, or free nerve endings. Complex neuronal activation occurs, which involves not only local sensitization of joint nociceptors but also modifications in central pain pathways.
Even though, the numerous pharmacological interventions are available for joint pain, there is much debate amongst clinicians about the best approach to the treatment of joint pain. NSAIDs which is frequently used for treatment in such cases, carries concerns related to gastro-intestinal system, cardiovascular system as well as central nervous system .
Hence there is a need of a safer alternative treatment option for relieving acute joint pain which is comparable to the modern medicines, without posing concerns to the subject's general well being.
Herbs are known to be used since ages in traditional literature and do not pose any potential health concern. Inspite of such positive attributes herbs are not employed in treatment of acute pains as there is lack of evidence proving the same.
In order to address the need of the hour Enovate Biolife has invented a novel poly herbal formulation E-OA-07 (Lanconone). Lanconone has been studied previously in patients with osteoarthritis has been proven efficacious . It has a good history of marketing and is sold in the United States, with no reported adverse event related to the product. However there is no concrete evidence proving the product's acute pain relieving dynamics, hence the current study has been employed to comprehend the effect of lanconone in joint acute pain.

开始日期2014-08-01

申办/合作机构

Vedic Lifesciences Pvt Ltd

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项与 Lanconone 相关的文献（医药）

2016-12-01·Trials4区 · 医学

A clinical trial comparing Lanconone® with ibuprofen for rapid relief in acute joint pain

4区 · 医学

ArticleOA

作者: Srivastava, Shalini ; Girandola, Robert N ; Loullis, Costas C

BACKGROUNDTo study the effect of Lanconone® (1000 mg) on acute pain on exertion as compared to the standard of care, Ibuprofen (400 mg).METHODThe study recruited 72 subjects diagnosed with mild to moderate knee joint pain on exertion. Subjects with Pain Visual Analogue Scale of more than 40 mm were included. Uphill walking was provided as the stressor using Naughton's protocol on a treadmill. The subjects walked for 10 minutes continuously followed by a rest period and baseline pain score for index knee joint was recorded. Subjects were administered a single dose of Lanconone® (1000 mg)/Ibuprofen (400 mg). Thereafter the same stressor was provided at 0.5, 1, 2, 3, 4, and 6 hours, subsequently, pain scores were recorded on a visual analogue scale. Double stopwatch method was used to evaluate the onset of pain relief and time taken to meaningful pain relief.RESULTBoth Lanconone® and Ibuprofen showed the first perceived pain relief at 65.31 ± 35.57 mins as compared to 60.82 ± 32.56 mins respectively. The mean time taken to experience meaningful pain relief in Lanconone® group was 196.59 ± 70.85 mins compared to 167.13 ± 71.41 mins amongst Ibuprofen group. The meaningful pain relief continued for 6 hours.CONCLUSIONThe current study successfully demonstrated rapid pain-relieving potential of Lanconone® which was comparable to Ibuprofen. No adverse event related to the interventions was reported in the study.TRIAL REGISTRATIONClinical trials.gov NCT02417506 . 21 January 2015.

2011-03-01·American Journal of Therapeutics4区 · 医学

Efficacy and Safety of E-OA-07 in Moderate to Severe Symptoms of Osteoarthritis: A Double-Blind Randomized Placebo-Controlled Study

4区 · 医学

Article

作者: Shakeel, Aliya ; Kulkarni, Mugdha P ; Rosenbloom, Richard A ; Shinde, Bhakti S

The efficacy and safety of a polyherbal preparation E-OA-07 was compared against placebo in patients with moderate to severe symptoms of osteoarthritis (OA) of the knee, in a double-blind, randomized, parallel groups study. Male or female subjects with American Rheumatism Association functional class II/III and Kellgren Lawrence grade 2 or 3 OA of the knee, who had moderate to severe OA symptoms as recorded by a score of at least 60 on the modified version of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, and an overall pain score of at least 70 mm on a 100 mm Visual analogue (VAS) scale were studied. Subjects received 2 capsules of E-OA-07 or placebo twice daily for 12 weeks and paracetamol up to 2 gm per day as rescue medication. Efficacy outcome measures were WOMAC and VAS scores, functional tests for joint mobility and gait, consumption of rescue medication, investigator's global assessment and subjects' opinion. Safety was assessed through incidence of adverse events and subject's assessment of tolerability. After 12 weeks of treatment, there was a significant reduction of WOMAC scores in the E-OA-07 group as compared with placebo (P < 0.01). Mean (±SEM) reductions in WOMAC scores of pain, stiffness, and physical function for E-OA-07 versus placebo were 8.86 (1.77) versus 2.50 (0.76), 3.00 (0.65) versus 0.75 (0.45), and 30.00 (5.22) versus 10.87 (2.18). Significant between-group differences were also observed for VAS scores of pain and stiffness. The symptom alleviating effect of E-OA-07 persisted over a follow-up period of 4 and 6 weeks as VAS pain and stiffness scores continued to remain statistically lower (P < 0.01) in the E-OA-07 group than placebo. Subject's opinion was significantly greater in favor of E-OA-07 than placebo, whereas both groups received favorable responses from investigator. Consumption of rescue medication and tolerability ratings were similar between the 2 groups. One E-OA-07 subject was hospitalized due to accidental fall and withdrawn from the study. No other serious adverse event occurred. The effect of E-OA-07 in relieving moderate to severe symptoms of OA of the knee is well tolerated, superior, and more persistent than placebo.

Journal of Pain Research3区 · 医学

<p>Effect Of E-OA-07 On Improving Joint Health And Mobility In Individuals With Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study</p>

3区 · 医学

ArticleOA

作者: Srivastava, Shalini ; Chaudhary, Jayesh A ; Girandola, Robert N

AIMThe aim of the present study was to evaluate the effect of E-OA-07 on individuals having osteoarthritis of the knee.BACKGROUNDLanconone^® (E-OA-07) is a widely marketed dietary supplement which has been previously studied in different clinical settings for managing chronic joint pain. This was a confirmatory study planned at a lowered dose regimen with the purpose of improving compliance and reducing consumer cost.METHODSMale and female participants aged between 40 and 65 years, with history of joint pain for at least 3 years, were recruited. Knee joint dysfunction of grade II/III was radiographically characterized as per Kellgren-Lawrence system of classification. Enrolled participants were randomized to receive E-OA-07 at a dose of 1000 mg/day or placebo over a period of 8 weeks. The primary efficacy parameter was assessment of change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score. Whereas, the secondary parameters explored in the study included WOMAC subscales of stiffness and physical function, EQ-5D-5L questionnaire, systemic inflammatory marker (hs-CRP) and self-assessment of treatment satisfaction.RESULTSAt the end of 8 weeks, joint pain severity as per WOMAC was found to be significantly reduced in the E-OA-07 group as compared to placebo (p<0.001). Similar improvement was observed in the subscales of stiffness and physical function which corresponds to significant improvement in the quality-of-life standards of E-OA-07 participants (p<0.001), reporting higher treatment satisfaction (p<0.001).CONCLUSIONE-OA-07 at a dose of 1000 mg/day was able to significantly reduce joint pain and thereby improve joint mobility in study participants. At the end of the study period, there was a clinically relevant change of 45.55%, 45.91% and 38.19% for pain, stiffness and physical function, respectively. Moving forward, studies could be planned for understanding the cartilage regenerative properties of E-OA-07.

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适应症	最高研发状态	国家/地区	公司	日期
急性疼痛	临床2期	印度	Enovate Biolife Pvt Ltd.	2014-08-01
急性疼痛	临床2期	印度	Vedic Lifesciences Pvt Ltd	2014-08-01
膝关节炎	临床2期	印度	Vedic Lifesciences Pvt Ltd	2009-05-28

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02417506 (Pubmed \| Trials)	N/A	关节痛	72	Lanconone® (1000 mg)	(艱鬱醖簾夢願範襯糧觸) = 淵築廠顧觸鑰壓鏇鏇鹹築艱壓鑰齋壓糧憲襯淵 (網壓構憲選糧齋選夢觸 )	-	2016-04-06
				Ibuprofen (400 mg)	(艱鬱醖簾夢願範襯糧觸) = 廠齋觸壓鏇淵築鏇憲衊築艱壓鑰齋壓糧憲襯淵 (網壓構憲選糧齋選夢觸 )