A Randomized open labelled controlled clinical study to evaluate the efficacy of Aparajita Churna in the management of Primary Insomnia.

Insomnia is a condition of unsatisfactory quantity and/or quality of sleep, which persists for a considerable period of time as per the International Classification of Diseases with code ICD-10 F 51.0.A study of general population in South India(2012), had found a prevalence of 18.6% for insomnia. There was increase in prevalence of Insomnia to 21% during COVID-19 pandemic and lockdown as per surveys conducted in India in 2020.The sleep related disorders though frequent, are under reported and their implications are often neglected.Primary insomnia refers to difficulty in initiating and maintaining sleep, not related to other mental disorder or physical condition; it constitutes about 15% of patients with chronic insomnia. The effects include fatigue or low energy, daytime sleepiness, impaired attention, concentration, or memory, mood disturbance, behavioral difficulties, impaired occupational or academic function, impaired interpersonal or social function.As per Ayurveda , Nidra is one among the Trayopasthambha (3 pillars of life) and its proper observance is considered necessary for the maintenance of life, whereas Nidranasha or Anidra (disturbed sleep) is said to cause various symptoms like Angamarda, Gaurava, Alasya, Jrumbha, Jadya, Glani, Bhrama, Apakti, Tandra. The National Ayurveda Morbidity Code(NAMC) given for Anidra is RA-1, which is closely related to Primary Insomnia.In conventional system of medicine, sedatives, tranquilizers and psychotropic drugs are generally used for sleep disorders, but they have also shown to develop addiction and dependence in the patient on extended use. They may induce other adverse effects like day- time sleepiness and CNS depression and also would have hazardous withdrawal effect. Considering the prevalence, effects on productivity; adverse effects and dependance on the contemporary interventions, it is highly relevant to search for a safer, effective and economical solution to manage Primary insomnia with special reference to Anidra.Aparajita (Clitoria ternatea Linn.), mentioned by Acharya Bhavaprakasha in Guduchyadi Varga is attributed with Sheeta virya , Tridoshahara, Medhya and5Rasayana property. Clitoria ternatea Linn. is also attributed with Anxiolytic, Tranquilizing, Sedative, Anti-stress, Nootropic, Memory enhancer property. Hence, taking the above background into consideration, it was thought worthwhile to evaluate the efficacy of oral administration of Aparajita Churna in the management of Primary Insomnia.Whereas, Ashwagandha , mentioned by Acharya Bhavaprakasha in Guduchyadi Varga being a proven drug for Primary Insomnia, is taken as a control drug for the present study, in form of Churna.