Search

OBJECTIVE: In a drug monitoring study, the efficacy and safety of Adhatoda vasica was studied on patients ages 12 to 80 with dust mite allergies. METHODS: The drug monitoring study (DMS) was performed with 103 patients suffering from symptoms of dust mite allergy (at least 4 of the following symptoms: runny nose, congested nose, sneezing, red eyes, itching eyes, watery eyes, coughing or difficulty breathing). The patient population was composed of 35 children over the age of 12 and 68 adults. The patients took, every hour or half hour up to 12 times daily, 10 drops (maximum 120 drops per day) of the investigational product, over a period of 7-9 days. To evaluate the efficacy, the decrease in allergy symptoms was assessed by means of a scaled evaluation by the physicians, as well as by a global evaluation of the efficacy by the physicians and the patients. Safety was estimated by the occurrence of adverse events, as well as by a global evaluation by the physicians and patients. RESULTS: Upon completion of the DMS, 83,5 % of the total group, 74,3 % of the children’s group, and 88,2 % of the adult group showed an improvement in dust mite allergy symptoms. Global evaluation of the efficacy by the physicians and the patients was 72 and 77 % respectively an assessment of "very good” to "satisfactory”. The global evaluation of the safety was rated 99 % by the physicians and 96 % by the patients "very good” or "good”. During the treatment period, 6 adverse events (AE) occurred. None of these AEs was classified as an adverse drug reaction.