[Year:2017] [Month:July-September] [Volume:1] [Number:3] [Pages:7] [Pages No:150 - 156]
Introduction: Osteopenia/osteoporosis is a condition characterized by decrease in bone mineral density. It is a major public health problem especially for women in India. The clinical picture of osteopenia/osteoporosis is similar to the condition of Asthidhatukshaya described in Ayurveda which is characterized by the loss of saarata of Asthi dhatu leading to increased predisposition to other bone-related pathologies. Laksha Guggulu, Mukta-Shukti Pishti, Ashwagandha Churna, and Pravala Pishti are some of the most common medicines used in the management of osteopenia/osteoporosis. However, safety data are not collected on these formulations. Objective: To critically analyze and present clinical safety of classical Ayurvedic formulations, viz., Laksha Guggulu, Mukta-Shukti Pishti, Ashwagandha Churna, and Pravala Pishti in osteopenia/osteoporosis, through multicenter open-label studies at different Central Council for Research in Ayurvedic Sciences (CCRAS) centers. Materials and methods: Data were collected from two different clinical studies executed in peripheral institutes of CCRAS and critically analyzed to assess the safety of four formulations: Laksha Guggulu, Mukta-Shukti Pishti, Ashwagandha Churna, and Pravala Pishti in osteopenia/osteoporosis. Safety assessments were done through liver function tests [LFTs; serum glutamate pyruvate transaminase (SGPT), serum glutamate oxaloacetic transaminase (SGOT), alkaline phosphatase (ALP), serum protein, albumin, globulin, and bilirubin] and kidney function tests (KFTs; serum urea and serum creatinine) before and after the trial period. Drug compliance and adverse drug reaction/adverse events, if any, were noted. Conclusion: The finding in the two clinical studies indicated that Laksha Guggulu, Mukta-Shukti Pishti, Ashwagandha Churna, and Pravala Pishti are clinically safe, effective, and tolerable as participants belonging to different age groups, gender, geographical areas, and having different prakriti responded well to the trial medications without any adverse reactions or adverse events.