Efficacy of Brimhana Nasya and Ashwagandha (Withania somnifera (L.) Dunal) root powder in primary insomnia in elderly male: A randomized open-label clinical study.

BACKGROUND: Decreased ability to fall asleep and/or stay asleep with daytime effects of sleep deprivation is identified as primary insomnia. Elderly due to the predominant Vata Dosha in the body are easily affected by this problem. Brimhana Nasya (nourishing nasal drop) with Ksheera Bala Taila and oral administration of Ashwagandha (Withania somnifera (L.) Dunal) root powder both are indicated in Ayurvedic classics for the management of insomnia. AIM: To determine the combined efficacy of oral administration of Ashwagandha root powder along with Brimhana Nasya with Ksheera Bala Taila in primary insomnia in geriatric. MATERIALS AND METHODS: This was randomized, open-label clinical study conducted at the hospital of Pt. Khushilal Sharma Government Ayurveda College and Institute Bhopal. Randomly selected 60 elderly patients with primary insomnia were randomly divided into two groups (30 in each group). Pittsburgh Sleep Quality Index was used to assess the symptoms of primary insomnia. Relief in the subjective symptoms was assessed in percentage. Then, the statistical significance of result within the group was assessed using Wilcoxon matched-pairs signed-ranks test and the comparative effect of therapy in both groups was assessed using Mann-Whitney test. Graph Pad InStat-3 software was used for statistical analysis. RESULTS: On subjective sleep quality 86.66% relief with P < 0.0001, on sleep latency 60.02% improvement with P < 0.0001, improvement in sleep duration was reported in 89.15% of patients with P < 0.0001 and improvement in sleep efficiency was reported in 90.14% of patients with statistically extremely significant P < 0.0001 were observed in combined therapy group (Ksheera Bala Taila Brimhana Nasya along with oral administration of Ashwagandha root powder). While 38.66% improvement in sleep efficiency, 40.39% relief in sleep disturbances and 37.05% improvement on subjective sleep quality was reported in group B patients, i.e., Ashwagandha root powder group. CONCLUSION: In 30 days treatment combined therapy was found more effective in the management of primary insomnia in the elderly compared with Ashwagandha root powder alone.