This study is a single arm clinical study to evaluate the analgesic effect of Trailokya vijaya vati plus. 60 sample size will be recruited by conducting 14 screening camps in 4 panchayats of Karunagapally. This screening camp includes Gynecological history, confirmatory tests like USG, and blood investigations after accessing the inclusion and exclusion criteria. The study protocol will be explained to the subjects by convenience and purposive sampling 60 subjects will be recruited for the study. The proposed intervention will be given in BD dose for 3 days of 4 consecutive menstrual periods followed by one menstrual cycle follow-up.
Menstrual Distress Questionnaire will be administered to assess the physical and behavioral mood changes and arousal symptoms during different phases and the severity of pain of recruited subjects of Primary Dysmenorrhea. The trial drug is Formulation Femme which is Trailokya Vijaya Vati tabled fortified by adding Aśvagandhā/ Thus, this formulation is chosen to manage pain in Primary Dysmenorrhoea. Each tablet of Trailokya Vijaya Vati Plus contains 62.5 mg of dried Vijaya (Cannabis ruderalis Linn) leaves and 62.5 mg of dried Vansh lochan (Bambusa arundianacea), Ashwagandha (Withania somnifera). Studies have reported anti-inflammatory activity of compounds Cannflavin A and B, which inhibit Prostaglandin E2 and 5-lipoxygenase in Vijaya20 (Cannabis ruderalis Linn). As per studies, Bambusa arundianacea (Vansh lochan) is also a potent anti-inflammatory active herb with the least toxic (no ulcerogenic) activity. This project is funded by Hemp Street, India.
