Double-blind trial of solid lipid Boswellia serrata particles (SLBSP) vs. standardized Boswellia serrata gum extract (BSE) for osteoarthritis of knee
-
Preeti D. Kulkarni
,
Neena D. Damle
Abstract
Objectives
The present study was planned to investigate the efficacy of SLBSP vs. standardized BSE for symptomatic knee osteoarthritis (OA) treatment.
Methods
It was a prospective, randomized, double-blind, double-dummy, placebo-controlled, and single-centre clinical trial for symptomatic osteoarthritis of knee. Subjects were randomized to receive SLBSP capsule+BSE Placebo or BSE tablet+SLBSP placebo for two months. Patients were allowed to take rescue analgesics (Acelofenac 100 mg). Improvement in pain and function was assessed utilizing WOMAC, VAS. Level of CTX-II in urine and serum levels of inflammatory cytokines including IL-2, IL-4, IL-6, TNF-α, and IFN-γ was measured initially and at end of treatment.
Results and conclusions
Western Ontario and McMaster Universities osteoarthritis index (WOMAC) and Visual Analog Scale score improved markedly in SLBSP as well as in BSE arm (p < 0.05). Difference in VAS and WOMAC scores between the two arms was not statistically significant. Most significant effect was observed in the need for rescue analgesics. SLBSP caused marked lowering of pro-inflammatory cytokines levels whereas a several fold increase was noted in the BSE arm (p < 0.05). Both groups showed marked improvement in pain, SLBSP being superior to BSE with respect to reducing the need for rescue analgesics in addition to modulating inflammatory cytokines.
Research funding: None declared.
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: Authors state no conflict of interest.
Informed consent: Informed consent was obtained from all individuals included in this study.
Ethical approval: The protocol was approved by the Institutional Ethics Committee of DY Patil University School of Ayurveda, Navi Mumbai. The study was conducted in accordance with the GCP principles stated in the Declaration of Helsinki.
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Articles in the same Issue
- Original Articles
- Five genetic polymorphisms of cytochrome P450 enzymes in the Czech non-Roma and Czech Roma population samples
- Assessment of tramadol pharmacokinetics in correlation with CYP2D6 and clinical symptoms
- The particulars of certain drugs’ effect on the endogenous coenzyme Q10 plasma level in patients with cardiovascular diseases
- Evaluation of the suitability of 19 pharmacogenomics biomarkers for individualized metformin therapy for type 2 diabetes patients
- Self-estimation of phenylketonuria patients on therapeutic diet. Psychological support
- Double-blind trial of solid lipid Boswellia serrata particles (SLBSP) vs. standardized Boswellia serrata gum extract (BSE) for osteoarthritis of knee
- Case Report
- Meropenem for management of valproic acid overdose: a case report
Articles in the same Issue
- Original Articles
- Five genetic polymorphisms of cytochrome P450 enzymes in the Czech non-Roma and Czech Roma population samples
- Assessment of tramadol pharmacokinetics in correlation with CYP2D6 and clinical symptoms
- The particulars of certain drugs’ effect on the endogenous coenzyme Q10 plasma level in patients with cardiovascular diseases
- Evaluation of the suitability of 19 pharmacogenomics biomarkers for individualized metformin therapy for type 2 diabetes patients
- Self-estimation of phenylketonuria patients on therapeutic diet. Psychological support
- Double-blind trial of solid lipid Boswellia serrata particles (SLBSP) vs. standardized Boswellia serrata gum extract (BSE) for osteoarthritis of knee
- Case Report
- Meropenem for management of valproic acid overdose: a case report
