Title of the Synopsis: A Comparative clinical study on Jatamansi (Nardostachys jatamansi DC.) Choorna and Arka in Anidra (Primary Insomnia)

Summary: 

NEED FOR THE STUDY:

Nidra is one of the trya-upa-stambha mentioned in Ayurveda along with Ahara and Brahmacharya. It is one of the pillars that holds healthy life. Nidra is one of the factors that provides complete relaxation to the mind and body thereby restoring the energy and potential of the body. It provides the body with time and environment to relax, heal itself from fatigue, exhaustion and repair cell damages. So sound sleep is an important part of a healthy life.

But in the modern era, there is great alteration in quantity and quality of sleep due to busy lifestyle, improper ahara and vihara, poor sleeping hygiene, work overload, anxiety and stress arising from day to day activities along with some chronic diseases and medications. This is highly affecting the quality of life of people leading to poor performance in all aspects of life. The consequences of insomnia are significant, such as depression, impaired work performance, work related / motor accidents, poor performance in career, education. Research findings suggest that sleep can increase the risk of developing obesity, diabetes, hypertension and heart disease.

 Insomnia is one of the most common but neglected condition. Various studies worldwide have shown the prevalence of insomnia in 10-30 % of the world population, some even as high as 50-60% of the population.³ Similarly a survey conducted by WHO in India reveals that 35% of the respondents have reported mild to severe trouble with sleep.⁴ This trend is increasing in the Covid-19 and lockdown situation. There is a high google search trend on insomnia during the recent covid-19 situation.⁵ Thus insomnia is obviously an important health problem that needs to be addressed.

 Jatamansi (Nardostachys jatamamsi DC), an aromatic herb of the Valerinaceae family possesses Tridosha and Raktadosha hara properties. Jatamamsi choorna is selected as standard control drug for Anidra because it has bhootaghna, nidrakara, medhya, balya, deepana-pachana, hrudya actions and thus is expected to have a comprehensive action over the samprapti vighatana of anidra. Moreover phytochemical and  pharmacological studies have shown several actions like sedative, anxiolytic, antioxidant, antiepileptic, neuroprotective, antidepressant, antifungal, antimicrobial, antioxidant, hepatoprotective, cardio protective actions. The study drug is taken its Arka form because Arka kalpanas are more potent, having a longer shelf life, fast action, palatable and required in smaller doses. The arka kalpana of Jatamamsi will help to preserve all its volatile active principles. This makes it more beneficial, palatable and user-friendly. Thus Jatamansi Arka is expected to provide better result for the management of Anidra.

OBJECTIVES OF THE STUDY

·         To evaluate the effectiveness of Jatamansi Arka in Anidra (Primary Insomnia)

·         To evaluate the effectiveness of Jatamansi Choorna in Anidra (Primary Insomnia)

·         To compare the effect of Jatamansi Arka and Jatamansi Choorna in Anidra (Primary insomnia)

STUDY DESIGN:

❖                  Type of study: Open label double arm prospective clinical study

❖                  Sampling method: Convenience sampling

❖                  Test: Pretest and Post test

❖                  Sample size: 40 subjects

❖                  Treatment duration: 28 days

SOURCE OF DATA:

Patients of Anidra (primary insomnia) will be recruited from in and out patient departments of Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka.

INCLUSION CRITERIA:

v  Diagnosed case of primary insomnia

v  Age group between 18-60 years.

v  Subjects of either of the gender, irrespective of socio-economic status.

v  Subjects who are ready to take part in the study with their consent.

EXCLUSION CRITERIA:

●       Use of any substance with psychotropic effects or properties knows to affect sleep wake cycle.

●       Subjects with secondary causes like breathing related sleep disorder, psychiatric related sleep disorder, sleep walking disorder.

●       Clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder.

●       Night shift workers and individuals who nap three or more times per week over the preceding month.

●       Females who are lactating or who are pregnant.

DIAGNOSTIC CRITERIA:

·         a detailed medical history will be taken and physical examination will be done from both Ayurvedic and modern point of view

·         Mental Status Examination (MSE) will be carried out to assess the mental health condition of the patient

·         routine hematological test will be done to confirm or rule out any other health issues

The guidelines mentioned in ICD-10 will be followed

v  A complaint of difficulty falling asleep, maintaining sleep, or non-refreshing sleep.

v  The sleep disturbance occurs at least three times per week for at least one month.

v  The sleep disturbance results in marked personal distress or interference with personal functioning in daily living.

v  Absence of any known causative organic factor, such as neurological or other medical condition, psychoactive substance use disorder or a medication

ASSESSMENT CRITERIA-

The quantity and quality of sleep will be assessed by using Insomnia Severity Index.

❖                  0–7   = No clinically significant insomnia

❖                  8–14 = Sub threshold insomnia

❖                  15–21 = Clinical insomnia (moderate severity)

❖                  22–28 = Clinical insomnia (severe)

ASSESSMENT OF SUBJECT- will be done before treatment and after treatment again