An exploratory single-arm open-label clinical study to evaluate the combined effect of Vamana and Sarasvata Churna in reducing excessive daytime sleepiness

Background

Excessive Daytime Sleepiness (EDS) is inferred as persistent sleepiness and often a general lack of energy during the day even after apparently adequate or even prolonged nighttime sleep. The subjects may not be identifying excessive daytime sleepiness but may present as feeling tired, lack of energy etc. They may seem apparently healthy and without any other systemic illness. The prevalence was found to be as high as 18 % in 2012 in United Kingdom. Also, it is a risk factor for diseases like Alzheimer's disease, Parkinson's disease and other neurodegenerative diseases. Conventional management (Modafinil, Sodium Oxybate and Stimulants) addresses only the subjective condition in EDS and is associated with adverse effects compromising the quality of life. In the current health scenario there is a need for alternative interventions to manage this disease. On analyzing this condition through Ayurveda, we could understand it as Nidradhikya (Excessive daytime sleepiness) which is caused due to vitiated Kapha Dosha along with Vriddha Tamoguna (increased Tamoguna) that can be managed by Shodhana (biopurification) followed Shamana (pacification) therapies.

Objective

This study was aimed to assess the combined effect of Vamana (therapeutic vomiting) and Sarasvata Churna in reducing Excessive Daytime Sleepiness.

Materials and methods

This was a single-arm exploratory open-label clinical trial. 10 subjects having EDS diagnosed using Modified Epworth Sleepiness Scale (MESS) with a score of 10–24 with proper exclusion were recruited from OPD and IPD, Department of Kāyacikitsa, Amrita School of Ayurveda. All the participants were clinically examined, sought for medical history and further checked biochemically to exclude any other systemic illness that may lead to this condition. Only healthy subjects with quality night sleep (assessed by PSQI) and without any other systemic illness were selected. The treatment protocol adopted was Vamana Karma followed by 30 days of Sarasvata Churna as Shamana Aushadha (medicine for pacification). Assessment was done using MESS on 0^th day and after 30 days of Shamana Aushadha Sevana. After completion of treatment, the results were statistically analysed using Wilcoxon Signed Rank Test and final conclusion was drawn.

Results

On analysis of the symptoms using Modified Epworth Sleepiness Scale, the mean total score reduced from 14.8 to 2.8 with 81.08 % relief in these 10 subjects and a significant p value < 0.05 after Vamana followed by 30 days of Shamana Aushadha Sevana.

Discussion

Vamana helps in Kapha Nirharana (expelling) which removes the Avarana (occlusion) of Manas seen in Nidradhikya. This results in Hrit Shuddhi (purity of heart) that helps in bringing the equilibrium of Mano Gunas (qualities of mind) (Satvoudaryam Tamojayaha) which forms the line of management. Sarasvata Churna which was administered as Shamana Aushadha possesses Medhya (Nootropic), Buddhi Smriti Dhriti Vardhaka (intellect, memory and patience promoting) attributes and is being indicated in Vicetas. Most of the drugs in Sarasvata Churna are Rasayana (rejuvenation) that imparts Indriya Bala (strengthening of senses) and Priti (contempt) to Manas by Prinana (nourishing) of Rasa Dhatu.

Conclusion

From this study, we could conclude that the combination of Vamana Karma followed by Sarasvata Churna administration is effective in reducing EDS.