An Open label Single-arm study to Evaluate the Effect of Siropicu and Padabhyanga with Ksirabala taila in the management of Insomnia in Menopausal Women

BACKGROUND Insomnia is characterized by long sleep latency, frequent awakening or prolonged period of wakefulness during the sleep period, or even frequent transient arousal. Insomnia that occurs for at least three nights a week for three consecutive months is considered chronic and results in social, occupational, and behavioral distress. Women complain more frequently of insomnia than men and insomnia increases with age. The prevalence of sleep disturbances in Postmenopausal women is about 28% - 63%. Menopausal Insomnia is associated with multiple adverse effects on quality of life, decreased work productivity, and increased healthcare utilization, and also with a higher prevalence of anxiety, depression, and cardiovascular diseases. Shira is considered as uttamanga, the place where the prana, controls all the activities and all the indriya’s are located. Shiro Pichu is one among the Murdhini taila. Murdhini taila is a chikitsa for Nidranasha. Padaabhyanga is considered as Nidrakrit ,Maruta Upashamana and Ksheerabala taila is Rasayana Mukyatama, Jeevana, Brihmana, Indriyaprasadana and Sukra Asruk dosha nashana effective in curing all 80 types of vata rogas and can be used as Pana, Basti, Nasya and Abhyanga.

RATIONALE AND NEED FOR STUDY Menopausal women show an increased prevalence of Insomnia for years after diagnosis and treatment. Neglected Insomnia in postmenopausal women will lead to impairment in their work or at home and thus decrease quality of life, memory problems, increase anxiety, depression, and reduced capacity in carrying out day-to-day activities, and also worsen the associated menopausal symptoms. Treatment protocols for Insomnia are mainly Hypnotic drugs and cognitive behavioral therapy. Prolonged use of Hypnotic drugs may result in drug dependence, sleepiness, hangovers in the morning, sleep impairment after discontinuation, and ultimately not cure Insomnia. In this scenario, it becomes more significant to find out the effect of other alternative therapies in managing this condition. Already proven methods are combined and incorporated into the management of Menopausal Insomnia to get better results. In Ayurveda Padaabhyanga and Shiropichu are advised as management for Nidranasha. Ksheerabala taila, the ingredients Ksheera is Jeevaniya, Nidrajanana, Bala (Sida cordifolia) and tila taila has Vata hara properties. In this study, an attempt is made to know the efficacy of Padaabhyanga and Shiropichu with Ksheerabala taila in the management of Menopausal Insomnia.

METHODOLOGY 30 patients attending Streeroga & Prasuti Tantra OPD & IPD of Amrita Ayurveda Hospital fulfilling the inclusion criteria will be recruited for the study. After taking informed consent, the procedure of shiro pichu and pada abhyanga will be explained and proper training will be given to the patient and bystander. A Pamphlet and video demonstrating the detailed procedure of shiro pichu and pada abhyanga will be also given to the patient. The patient is advised to do, Shiro pichu 1 hour before sleep with a duration of 30 minutes after that patient is advised to rest for 10 minutes after the procedure. The Duration of Shiropichu is 7 days. Padaabhyanga should be done on each foot for 15 minutes twice daily and advised to take rest for 10 minutes after the procedure. The duration of pada abhyanga is 15 days. Assessment will be done on the 1st Day (D1) - On the day of recruitment, on the 8th Day (D8) - After the completion of Shiro Pichu, and 16th Day (D16) -After the completion of Padaabhyanga. The patient will be advised to report on the 8 th day, the assessment will be done, and also advised to stop Shiropichu and continue Padaabhyanga for 8 days. Assessment criteria used in the study are the Pittsburgh sleep quality Index and Insomnia severity index. •

DURATION OF STUDY: 15 days