Efficacy of Mamsyadi Ghana capsule in Insomnia Disorder - A randomized controlled trial.

Background: Insomnia disorder is a common sleep disorder. Mamsyadi Ghana Capsule (Ayurveda medication) is assessed for its role in the management of Insomnia disorder.

Objective: The study was planned to evaluate the efficacy of Mamsyadi Ghana Capsule in the management of Insomnia disorder METHODS: 50 patients attending the OPD of the institute, meeting the diagnostic criteria of Insomnia Disorder (DSM 5) of age group 20-80 years of both sex participated in the study. They were randomly divided and Tagara Churna group (TC) received Tagara Churna (Valeriana wallichi DC) 4 gram and Mamsyadi Ghana group (MG) received Mamsyadi Ghana Capsule 500 mg respectively thrice a day for 30 days. Evaluations were done through Insomnia severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness scale (ESS), Sleep diary recordings of past 15 days and depression Anxiety and Stress Scale (DASS). Clinical assessments were on 15th and 30th day. Blood parameters like haemoglobin, liver function tests, serum creatinine were evaluated at baseline and post study.

Results: Study showed that Mamsyadi Ghana Capsule produced significant improvement compared to Tagara Churna in ISI and ESS (p = 0.01) and effect size was large. Both interventions were comparable in PSQI, DASS, sleep diary variables. Both the interventions produced significant improvement in ISI, ESS, PSQI, DASS (p < 0.001) and sleep diary variables on within group comparison. Serum Creatinine and Liver function tests showed that both the interventions had good safety profile.

Conclusion: Study showed that Mamsyadi Ghana Capsule is better than the Tagara Churna in Insomnia Disorder and both showed anxiolytic and antidepressant effect.