A Study on the Safety Spasmolytic and possible Endocrinological Modulatory Effects of Siddha Herbo Mineral Formulations NIS KM and NIS KLM in Primary Dysmenorrhoeic Dhoora Soolai state A Preclinical and Clinical Approach

Abstract

BACKGROUND: Of the many conditions affecting women. dysmenorrhoea or painful menstrual cramps is one of the most prevalent problems which ail them. Dysmenorrhoea can disrupt personal life and is a significant public health problem associated with substantial economic loss related to work absences. Ten percent of women with this condition suffer from severe pain that can be severely incapacitating. The annual economic loss has been estimated several million work hours and dollars. Primary Dysmenorrhoea is defined as unbearable menstrual cramps with no underlying pelvic pathology, presenting itself first in early teens 2-4 years after menarche affecting the adolescents and women in early 20s. Around 60 percentage of adolescent female population are reported to suffer from Primary dysmenorrhoea. In this study two Siddha herbo mineral formulations, Kariuppu Mezhugu (NIS KM) and Kanagalinga Mezhugu (NIS KLM) were chosen from the celebrated Siddha literature Anuboga Vaithya Navaneetham. Though the above formulations are used in practice for years, there is no scientifically published information available. Considering this enormous social burden of Primary dysmenorrhoea it was planned to introduce these drugs as a Siddha therapeutic regimen which would serve to produce a breakthrough in the management of this incapacitating gynecological public health problem of Primary dysmenorrhoea. Hence it was decided to standardize these formulations, determine the safety, pharmacological activities and clinical effectiveness of these drugs individually in two groups of Primary dysmenorrhoeic individuals. OBJECTIVE: To evaluate the efficacy of NIS KM and NIS KLM in the management of pain in Primary dysmenorrhea (Dhoora Soolai). CONCLUSION: Herbo-mineral formulations Kariuppu Mezhugu (NIS KM) and Kanagalinga Mezhugu (NIS KLM) exhibited no toxicity on short-term administration. The efficacy studies showed that the test formulations were highly effective in relieving the dymenorrhoeal cramps in human studies.