Evaluation of Efficacy and Safety of Evecare Syrup in Menstrual Irregularities: A Multicentric, Post Marketing Surveillance Study.

ABSTRACT

A total of 1,000 female patients aged between 18-45 years with menstrual irregularities and those willing to give informed consent were included in this multicentric, post marketing surveillance study. At the initial visit, a detailed medical history, symptomatic evaluation and gynecological evaluation was carried out in all the patients. Out of the 1,000 patients, 372 had dysmenorrhea, 388 had menorrhagia and 240 patients had oligomenorrhea. Each patient was administered Evecare Syrup at a dose of 15 ml, twice-daily for a period of three months. Statistical analysis was carried out using GraphPad Prism, Version 4.03. In 372 patients suffering from dysmenorrhea, 14 had slight abdominal pain and 358 of them had total absence of symptoms at the end of treatment. In patients with menorrhagia, significant reduction was observed in the mean score of duration of menstruation, quantity of blood loss, blood flow loss and character of blood flow changed from clot to flow after treatment with Evecare Syrup. At the end of three months of treatment, 238 patients had normal menstruation, normal duration and flow in oligomenorrhea. No clinically significant adverse drug reactions were reported except for one patient, who had symptoms of nausea; one patient had symptoms of gaseous distension at third month of treatment and it did not require additional treatment or drug withdrawal. The results of the present study showing clinical benefit of Evecare Syrup appear promising in the management of menstrual irregularities.