A double blind, randomized, crossover, two period, parallel group, single center, placebocontrolled study to evaluate safety and efficacy of WSCS IIIM (comprising extract A andExtract B) for sleep disorder(s) in otherwise healthy volunteers

The objective of this study is to validate the safety & efficacy of oral administration of Ashwagandha capsule (comprising extract A and Extract B) for sleep disorder (Insomnia) in otherwise healthy volunteersInsomnia, also known as sleeplessness, is a sleep disorder in which people have trouble sleeping. They may have difficulty falling asleep, or staying asleep as long as desired. Insomnia is typically followed by daytime sleepiness, low energy, irritability, and a depressed mood. It may result in an increased risk of motor vehicle collisions, as well as problems focusing and learning.

Withania somnifera, known commonly as Ashwagandha or winter cherry, is an evergreen shrub in the Solanaceae or nightshade family that grows in India, the Middle East, and parts of Africa.

Several other species in the genus Withania are morphologically similar. It has been traditionally known since ancient times in India for its numerous beneficial health activities. WS is one of the most important herbs in Ayurveda, which has been used for >3000 years in stress management, energy elevation and improving cognitive health and to lower inflammation, blood sugar levels, cortisol, anxiety, and depression. The plant is an erect, grayish, evergreen shrub with long tuberous roots, short stems, ovate and petiolate leaves, and greenish axillary and bisexual flowers. The leaves, roots, stems and flowers bear medicinal values with 29 common metabolites derived from the leaves

and root extracts. To date, this medicinal plant has been found to have anti-epileptic, antiinflammatory, anti-arthritic, anti-depressant, anti-coagulant, anti-oxidant, anti-diabetic, anti-pyretic efficacies along with palliative effects such as analgesic, rejuvenating, regenerating and growthpromoting effects.