Clinical evaluation to assess the safety and efficacy of coded herbal medicine "Dysmo-off" versus allopathic medicine "Diclofenac sodium" for the treatment of primary dysmenorrhea.

The purpose of the present research work was to carry out clinical study on primary dysmenorrhea to comparatively examine the coded herbal drug formulation "Dysmo-off" with authentic allopathic medicine "Diclofenac sodium" (NSAIDs). A random controlled clinical trial was conducted to compare the efficacy and safety of coded herbal medicinal treatments Dysmo-off with Diclofenac sodium/Phenylacetic acid. These evaluations were based on verbal rating scale so as to ascertain the rate of analgesic effects on dysmenorrhoeic pain. The patients were randomly allocated with the ratio of 1:2 for controlled treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) (n = 40) received Diclofenac sodium tablets twice daily for 4 days (50 mg one day prior to and three days after the menstruation), and test treatment with Dysmo-off (n = 80) received powdered Dysmo-off twice daily for four days (5 g one day prior to and three days after the menstruation). Treatment lasted for 4 consecutive menstrual cycles. Hemoglobin, ESR and ultrasound were measured at baseline during study. All subjects were clinically studied and completed the assigned therapy during the period May 2001 to June 2004.

RCT Entities:   Population Interventions Outcomes