A pilot clinical trial to evaluate the effect of Thalam with Karuthavattu and Ksheerabala (101) in insomnia disorders w.s.r to EEG and sleep indices

Insomnia is defined as difficulty in initiating or maintaining sleep or early

morning awakening associated with impaired daytime time functioning viz reduced

cognitive performance fatigue or mood disorders. As Age increases, the prevalence of

insomnia also increases. As insomnia can lead to a lot of systemic disorders and

psychological disorders, management is crucial.

Thalam is a unique method of drug delivery developed by Vridha Vaidyas of Kerala

and is practiced widely. It is an integral part of Ayurvedic treatment showing deep knowledge

and precision in medicinal application. Thalam with karutha vattu and ksheerabala (101)Is

widely practiced in Kerala for sleeplessness.

There are numerous studies claiming effectiveness in insomnia with ayurvedic

intervention. But the realm of scientific validation with electrical changes the intervention

brings about remains unscathed, the main reason being difficulty in accessing affordable

technology. . The objective of the study is to evaluate whether thalam with Karuthavattu

and Ksheerabala (101) Is effective in inducing EEG changes in Insomnia disorders. As this

is A pilot clinical trial , a total number of 12 patients having Insomnia disorder is

administered Thalam and pre and post treatment Polysomnography ( PSG)  will be evaluated along with sleep

quality indices

.For sleep indices, parameters taken will be Sleep latency, total sleep time (TST), Sleep

efficiency, percentages of REM and NREM sleep. and its sub-stages Nl, N2 and N3.

The PSG parameters for objective assessment of sleep during pre and post treatrnent will

be done using basic EEG, EMG and EOG required sensors as per AASM (American

Association of Sleep Medicine): EEGs including O1, 02, F3, F4, C3, C4 channels along

with mastoid references Ml, M2; EOG (left and right) and chin EMG lbr insomnia and

ECG.

Keywords: - Insomnia disorders, Thalam ,Karuthavattu, Ksheerabala(101) ,EEG, PSG