A Clinical Trial to evaluate the effectiveness of Sanjeevi Thailam (External-oil bath) and Plain Amukkara chooranam (Internal) with Sanjeevi Thailam(External-oil bath)in the management of Thookaminmai(Insomnia)among out-patients attending Ayothidoss Pandithar Hospital, National Institute of Siddha.

BACKGROUND:Siddha system is one of the ancient and codified medical systems of India. According to the Siddha system, diet and lifestyle play a major role in maintaining promotion of health and in the management of diseases. In the current world, life style modification like food habit, lack of exercise, stress factor causes many diseases. Insomnia is one among them. It may be correlated to Thookaminmai or Nithiraiinmai in siddha system of medicine.            Insomnia a type of sleep disorder is one among the life style modification disorder which is a serious health problem among older adults due to its linkage with worsening general health, reduced quality of life, and morbidities, such as falls, institutionalization, and cognitive impairment. Age-related biological changes that result in less deep sleep, more fragmented sleep, and early morning wakeups are one theory of why older adults are more likely to experience insomnia.             In fact, chronic illnesses are a significant risk for insomnia. It is estimated that the majority of people with insomnia (approximately 75%–90%) have an increased risk for comorbid medical disorders, such as conditions causing hypoxemia and dyspnea, gastro esophageal reflux disease, pain conditions, and neurodegenerative diseases. Importantly, a variety of primary sleep disorders as well as circadian rhythm disorders are frequently comorbid with and often lead to insomnia.OBJECTIVE:                   To compare the therapeutic effectiveness of Sanjeevi thailam (external-oil bath) and Plain Amukkara Chooranam (internal) with Sanjeevi thailam(external-oil bath) in the management of Thookaminmai (Insomnia) using Pittsburgh Sleep Quality Index. METHODOLOGY: STUDY DESIGN :       Interventional Study.STUDY PLACE :      Out Patient Department,Ayothidoss Pandithar Hospital,                                         National Institute of Siddha,                                                            Chennai-47. SAMPLE SIZE :      20 (Group A – 10, Group B – 10)STUDY PERIOD :      48 DAYS JUSTIFICATION FOR CONDUCT OF THE STUDY:Nowadays, there is an increasing prevalence of insomnia throughout the world. Though lifestyle intervention is the mainstay of treatment for insomnia, the need for medications of the same is rising.In other system of medicines, the regular intake of medicines leads to drug dependency both physically and emotionally. The damage by taking sleeping pills so often may have continuous, even life-long consequences that involve addiction to sleeping pills and all the side effects that come along with it.So, the drug “SANJEEVI THAILAM and PLAIN AMUKKARA CHOORANAM with SANJEEVI THAILAM” is chosen as a safer option in the management of insomnia.  DATA ANALYSIS:After enrolling the participant in the study, a separate file will be maintained for each and every participant. All the Clinical research Forms will be collected and safely stored for analysis. All clinical data entered in the Proforma will be analyzed. The data entry will be monitored in the presence of guides under the supervision of the Head of the department. All collected data will be entered using MS Access/excel software on the computer. All forms will be scrutinized by the Statistician for logical errors and incompleteness of data to avoid bias. The data will be statistically analyzed. No modification in the results will be permitted for unbiased reports. OUTCOME:            To compare the reduction in the scores by 25-50% of  Insomnia participants between groups A and B (before and after treatment) using the Pittsburgh Sleep Quality Index. RESULTS AND DISCUSSION: The results will be statistically analysed and reported. KEYWORDS:Thookaminmai,Insomnia.