An open label clinical trial of an orally-dosed herbal formulation Zinova (Registered Trademark) for the prevention of dysmenorrhoea (menstrual pain).

This is a single-site, open-label short-term clinical trial with baseline data collection. Approximately 20 female participants aged between 18 and 45 years will be recruited from the CRO’s participant database and public media. Following initial screening via telephone, potential participants will attend the clinic for an information session and will be requested to provide their consent for inclusion in the trial. Consenting potential participants will undergo a medical assessment including lifestyle, current medications, physical examination, medical history, and menstrual history; this data will be used for the comprehensive screening and to provide contextual data for the study. The primary outcome measure is the pain VAS rating scales. The secondary outcome measure is analgesic use. The expected duration of the trial is five consecutive menses (approximately five months) for each participant. Baseline data will be collected during the first 2 menstrual cycles prior to intervention and for 3 months while on treatment.