title: Pharmacovigilance study of Ayurvedic medicine in Ayurvedic Teaching Hospital: A prospective survey study.
abstract: BACKGROUND
  Though Ayurveda is practiced in the Indian subcontinent since centuries, there is a paucity of systematic documentation related to the occurrence of adverse drug reactions (ADR) and other issues regarding the safety of Ayurveda medicines.
  
  
  OBJECTIVE
  To monitor and analyze the pattern and frequency of ADR to Ayurvedic medicines in an Ayurvedic hospital setup.
  
  
  METHODS
  In this prospective study, ADR monitoring was done in KLE Ayurveda Secondary Care Hospital, Belgaum, Karnataka, India by spontaneous and intensive monitoring technique for a span of 1-year (June 2010 to May 2011). Data pertaining to patient demography, drug and reaction characteristics, organ system involved and reaction outcomes were collected and evaluated. The reaction severity and predisposing factors were also assessed.
  
  
  RESULTS
  In a span of one year, 84 adverse drug events were reported out of which 52 confirmed as ADR. The overall incidence of ADR in the patient population was 1.14%, out of which 23 (44.23%) were related to Panchakarma (detoxification process), 13 (25.00%) related to the herbal formulations and 06 (11.53%) were of Rasa Aushadhi (mineral or herbo-mineral formulations). The commonly affected organ systems were gastrointestinal system 24 (46.15%) and skin 15 (28.84%). The majority of the reactions were moderate 30 (57.69%) to mild 20 (38.46%) in severity. Most patients recovered from the incidence.
  
  
  CONCLUSIONS
  The present work has documented the incidence and characteristic of ADR to Ayurvedic medicine in a typical Ayurveda hospital setup. This will help in developing various strategies for boosting pharmacovigilance in Ayurveda, thereby ensuring safer use of Ayurveda medicines.
authors.affiliation: Department of Dravyaguna, RGES's Ayurvedic Medical College Hospital and PG Research Center, Ron, Gadag, Karnataka, India.
authors.forename: Manjunath N
authors.initials: MN
authors.lastname: Ajanal
authors.affiliation: Department of Dravyaguna, KLEU's Shri BMK Ayurved Mahavidyalaya, Belgaum, Karnataka, India.
authors.forename: Shradda U
authors.initials: SU
authors.lastname: Nayak
authors.affiliation: Department of Research and Development, Rasayani Biologics Pvt Ltd., Pune, Maharashtra, India.
authors.forename: Avinash P
authors.initials: AP
authors.lastname: Kadam
authors.affiliation: Department of Panchakarma, KLEU's Shri BMK Ayurved Mahavidyalaya, Belagavi, Karnataka, India.
authors.forename: B S
authors.initials: BS
authors.lastname: Prasad
keywords: Adverse drug reactions; Ayurveda; Panchakarma pharmacovigilance; Rasaushadi; herbal medicine