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Abstract
Purpose
Osteoarthritis is the single most common cause of disability in older adults with an estimated 10% to 15% prevalence in individuals above 60 years. The contemporary medications include nonsteroidal anti-inflammatory drugs acetaminophen, cyclooxygenase-2 inhibitors, and surgical interventions. In view of safety issues regarding their longterm use, necessitating search for effective and safe alternatives, we evaluated Capsule Longvida® Optimized Curcumin prepared using solid lipid curcumin particles (SLCP) technology in patients with knee osteoarthritis.
Patients and methods
Eligible patients fulfilling American College of Rheumatology Criteria were randomized to SLCP group (400 mg twice daily delivering 80 mg of curcumin per capsule) or Ibuprofen with placebo group (400 mg each once daily) for 90 days. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Visual Analog Scale (VAS) were used for clinical assessment of knee pain and function. Degree of knee flexion and swelling were also noted. Blood biochemistry included hemogram, blood urea, creatinine, Random blood sugar and inflammatory markers viz. PGE2, TNF α, IL6, IL1β and LTB4 while urine examination included degenerative marker CTX II. The parametric data was analyzed using unpaired t test while non-parametric data was analyzed using Friedman’s test or Mann Whitney t test as applicable. A level of p<0.05 was considered as statistically significant.
Results
Out of 50 recruitments, 25 from the Ibuprofen group and 17 from the SLCP group completed the study with significant improvements in VAS and WOMAC scores indicating comparable efficacy of SLCP in alleviating pain with Ibuprofen. None of the markers displayed significant changes. Except one withdrawal in the study group due to rash and itching, the study drug was found safe.
Conclusions
SLCP in a dose of 160 mg daily was found to be effective and safe in alleviating symptoms in patients suffering from knee osteoarthritis when administered for 90 days.
Acknowledgments
Authors acknowledge support from Director, IRSHA and Superintendent, Bharati Ayurved Hospital. This study has been funded by Pharmanza Herbals Pvt. Ltd. Dr Lal Lachhmandas Hingorani and Dr Amol Panjabrao Deshmukh are listed as co-authors in this study and they represent the sponsor Pharmanza Herbals Pvt. Ltd.
Ethics approval and consent to participate
The study was approved by Bharati Vidyapeeth Deemed University College of Ayurveda Ethics Committee (BVDUCOA-EC)/127 in the year 2015 and performed in compliance with the Helsinki Declaration and ICH-GCP guidelines. Trial registration number: CTRI/2015/07/006061 registered retrospectively. Registry- Clinical Trial Registry of India. Registered on July 31, 2015.
Abbreviations list
WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index; VAS, Visual Analog Scale; OA, osteoarthritis; NSAIDs, nonsteroidal anti-inflammatory drugs; COX, cyclooxygenase; TNF α, tumor necrosis factor alpha; IL, interleukin; SLCP, solid lipid curcumin particle; ACR, American College of Rheumatology; BMI, body mass index; PGE2, prostaglandin E2; LTB4, leukotriene B4; CTX-II, C terminal telopeptides of type II collagen; LOX, lipoxygenase.
Data sharing statement
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Disclosure
The authors report no conflicts of interest in this work.