Safety and Efficacy of a Standardized Extract from Leaves of Dalbergia Sissoo in Healing of Long Bone Fracture: A Pilot Clinical Study

Abstract

Introduction: Healing of long bone fracture is a complex phenomenon and usually take months to years to recover completely. Varied products from different systems of medicine have been tried to accelerate fracture healing process. In recent preclinical studies it is found that standardized extract of leaves of Dalbergia sissoo accelerated fracture healing in rats by stimulating bone regeneration. The bone regeneration activity of herb is attributed to a novel compound CAFG. Aim: To evaluate the safety and efficacy of a standardized extract of Dalbergia sissoo (DSE) leaves in patients with long bone fracture. Materials and Methods: This was a single arm, pilot clinical study conducted at Nashik, Maharashtra. A total of 16 patients with lower or upper limbs long bone fracture were enrolled in this study to receive oral 300mg DSE capsules (twice daily for 2 months). The primary endpoint was fracture healing, assessed radiologically at week 2,4,6 and 8. Safety was evaluated by monitoring adverse event and biochemical investigations. Results: Treatment with DSE resulted in fading of fracture line in subsequent follow up visits and restored functional mobility. At the end of the study (week 8) all fractures were healed. No clinically significant adverse events were reported. At the end of the study, SGOT, SGPT and urea were significantly reduced compared with baseline. Conclusion: Overall, this study demonstrated that a standardized extract of DSE leaves was well tolerated with no safety concern and has a potential of fracture healing.