A Randomized Comparative Clinical Trial on Efficacy of Agni Kumar Rass and Maha Ajmodadi Taila Nasya in Subclinical Hypothyroidism With Special Reference to Agnimandhya.

INTRODUCTION:

Thyroid disorders have become very common in India as well as globally and according to various studies about 42 million people in India are suffering from these disorders. Early diagnosis and treatment remains the corner stone of management. The thyroid may be primary if the pathology exists in thyroid gland, secondary if it is in pituitary and tertiary if the pathology lies in hypothalamus. Hypothyroidism is commonly caused due to changes in dietary habits, sedentary lifestyle, stress, smoking, family tendency etc. Hence hypothyroidism is second to Diabetes mellitus is prevalence as the most common endocrine disorder. The symptoms of hypothyroidism are tiredness, excessive weight gain, cold intolerance, muscle pain, stiffness, edema including periorbital edema, hair loss, hoarseness of voice, constipation, depression etc. Thyroid hormones play a very important role in our body’s metabolism. Its functions are similar to the those of Agni. According to Ayurveda, the function of thermogenesis and metabolism in the body is principally related to Agni. If Agni of a person is vitiated whole metabolism of the body will get disturbed and it will give rise to various diseases. In Ayurveda, clinical manifestations of subclinical hypothyroidism can be considered as a state of dominance of Kapha associated with Margavaranajanya Vataprokopa. Hence we can indirectly relate hypothyroidism to Agnimandhya. More ever there are many diseases which are not mentioned directly in Ayurveda texts and hence are considered as Anukta vikara and thyroid disorder can also be included under the same. Galaganda can also be considered under Hypothyroidism based on its symptoms. As Ayurveda has shown a promising outcome in different metabolic disorders, different clinical studies has shown a significant benefit in subclinical hypothyroidism through Ayurvedic oral medicinal treatment. But no studies are published or done with the intervention of nasya in the management of hypothyroidism. Although very few review articles are published regarding nasya in hypothyroidism. Subclinical hypothyroidism (SCH) is biochemically defined as an elevated level of thyroid stimulating hormone (TSH) with normal level of free thyroxine (FT4) in the blood with minimal or no signs and symptoms of thyroid dysfunction. The most common cause of subclinical hypothyroidism is chronic autoimmune thyroiditis associated with antithyroid peroxidase antibodies (Hashimoto’s thyroiditis) but it can also occur due to other causes. Subclinical hypothyroidism (SCH) can be classified as Mild Grade 1 when upper limit of TSH is 9.9 mIU/L and severe grade 2 when TSH ≥10mIU/L. Where in patients are asymptomatic, but clinical manifestations similar to overt hypothyroidism are present in milder form.3 Several meta-analyses of observational studies have revealed an association between SCH and coronary artery diseases. -* Studies have reported prevalence of hypothyroidism in India as 10.95% being highest in the age group of 46 to 54 years (13.11%) and lowest in 18 to 35 years (7.53%) and that of SCH being highest (8.93%) in persons above 55yrs and lowest (6.91%) in age group of 18-35yrs. The risk of progression from SCH to overt hypothyroidism is 3.3–11.4% per year which is even higher in patients with thyroid peroxidase antibodies. In Vangasena Samhita there is reference of Mahaajamoodadi taila Nasya in Galaganda which is having dravyas which are having all ushna veerya. Nasya is considered as a dwara to Shira and there are many theories about Nasya Drug reaching the Hypothalamus and Pituitary which are indirectly responsible for the functioning of the thyroid gland. The Hypothalamus links the nervous system to the endocrine system via pituitary gland. Hence Nasya may prove to be more fruitful therapy in management of hypothyroidism. Agni kumara Rasa is also having deepana, pachana and Agni uttejaka properties which may correct the Agni Mandhya. Hence Randomized Comparative Clinical Trial is proposed on oral administration of Agni Kumara Rasa and Nasya with Mahaajamoodadhya taila. No studies have so far been conducted on the role of Nasya in Subclinical Hypothyroidism and also on oral administration of Agni kumara rasa. Hence keeping in mind all the above parameters a study is proposed entitled " A Randomized Comparative Clinical Trial on Efficacy of Agni Kumar Ras and Maha Ajmodadi Taila Nasya in Subclinical Hypothyroidism With Special Reference to Agnimandhya.”

Need for the study:

Hypothyroidism is second most common metabolic disorder after diabetes mellitus. 10.9% of population are suffering from Hypothyroidism in India. Few clinical studies has been done in thyroid disorder with oral intervention but not even a single study is done on nasya therapy. Agni Kumara Rasa is a novel formulation found in Bhaisajya ratnawali 10/117-122 which has not been researched yet and is particularly mentioned in Agni mandhya chikitsa. Nasya in Hypothyroidism is a novel idea as there is no research done so far as Ayurveda postulates as “Nasa hi Shiraso dwaram” and the hypothalamus links the nervous system to the endocrine system via pituitary gland and there are chances of Nasya drug reaching this area via the olfactory pathway. Likewise Mahaajamoodadi taila is a specific oil mentioned in Galaganda in Vangasen samhita. Ayurveda has shown promising results in different metabolic disorders in various clinical studies on hypothyroidism. Agnimandhya can be best corrected through Ayurveda which may stimulates proper production of thyroxine hormone.