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Double-blind trial of solid lipid Boswellia serrata particles (SLBSP) vs. standardized Boswellia serrata gum extract (BSE) for osteoarthritis of knee

Preeti D. Kulkarni EMAIL logo , Neena D. Damle , Sumer Singh , Krishnat S. Yadav , Minal R. Ghante , Vaidhun H. Bhaskar , Lal Hingorani and Vikram S. Gota

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.


Corresponding author: Dr. Preeti D. Kulkarni, Associate Professor and HOD, School of Pharmacy and Medical Science, Singhania University, Pacheri Bari, Jhunjhunu, 333515, Rajasthan, India; and Gahlot Institute of Pharmacy, Koparkhairane, Navi Mumbai, 400709, India, Mobile: +91 22 27550816, E-mail:

  1. Research funding: None declared.

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Informed consent was obtained from all individuals included in this study.

  5. 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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Received: 2020-02-10
Accepted: 2020-02-23
Published Online: 2020-06-08

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