RANDOMIZED OPEN-LABELLED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF LAVANGADI CHURNA IN GRAHANI WITH SPECIAL REFERENCE TO IRRITABLE BOWEL SYNDROME

Abstract

Background & Objectives: Grahani was described as an Ann avaha Srotovikara with Mandhagni as an important underlying factor and altered bowel movements as a characteristic manifestation. Based on the symptomatology and absence of detectable structural abnormalities, the condition was correlated in the study with Irritable Bowel Syndrome (IBS). The present study was undertaken to clinically evaluate the efficacy of Lavangadi Churna in Grahani with special reference to IBS and to compare its effect with Bruhad Gangadhara Churna. Methods: A randomized, open-labelled, parallel-group, active-controlled clinical study was conducted in 30 subjects fulfilling the study criteria. Subjects were randomly allocated into Group A (n=15), receiving Lavangadi Churna, and Group B (n=15), receiving Bruhad Gangadhara Churna. Both interventions were administered orally for 30 days followed by a 15-day drug-free follow-up. Subjective parameters included Baddha Mala Pravrutti, Drava Mala Pravrutti, Muhur Muhur Mala Pravrutti, Udara Shoola, Amayukta Mala Pravrutti, Flatulence and Quality of Life. Assessments were performed on Day 0, Day 30 and Day 45. Within-group analyswas used the Friedman repeated-measures analysis of variance on ranks, while between-group comparison used the Mann-Whitney U test. Effect size was assessed using Kendall's W for Friedman analyswas and r = Z/√N for other non-parametric analyses. Results: Group A showed statistically significant improvement in all assessed subjective parameters after treatment, with highly significant changes reported for Baddha Mala Pravrutti and Amayukta Mala Pravrutti, and significant changes in Drava Mala Pravrutti, Muhur Muhur Mala Pravrutti, Udara Shoola, Flatulence and Quality of Life. Several improvements remained statistically significant during follow-up. Group B also showed significant or highly significant improvement across the assessed parameters. Between-group comparisons at Day 30 and Day 45 were non-significant for all parameters. The parameter-wise overall improvement ranged from 60% to 87% in Group A and from 50% to 89% in Group B. Conclusion: In the present study, both Lavangadi Churna and Bruhad Gangadhara Churna produced significant improvement in the assessed subjective parameters of Grahani with special reference to IBS. No statistically significant difference was observed between the groups at Day 30 or Day 45. The study therefore reported Lavangadi Churna as clinically comparable to Bruhad Gangadhara Churna for the assessed parameters.