Gampaha Wickramarachchi Ayurveda Institute

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    Hypoglycaemic effect of selected ayurvedic formula (DM-13) in ikshumeha (Niddm-diabetes mellitus type 2) a clinical trial
    (Gampaha Wickramarachchi Ayurveda Institute: ., 2004) CHANDRASIRI, WAL
    The history of Prameha (Diabetes) runs back to the dates of earliest civilizations. The knowledge of medicine transmitted to East and West along with the migration of Egyptain communities. Ayurveda, the system of medicine originated in India, acquired its basic concepts from Egyptains and further developed by Aryans. Modern Medicine, developed into a system in Europe, originated in ancient Egypt and Babylonia. Both systems of Medicine bare a common root of thought. In classical texts of Ayurveda, lkshumeha is included in the disease "prameha". Many scholars consider the Diabetes Mellitus as Madhumeha, is an incorrect interpretation. Madhumeha, the fatal stage of prameha, represents a particular stage of Diabetes Mellitus and many other diseases of the kidney. Lkshumeha, the selected condition of the study, includes Diabetes Mellitus in the absence of renal damage. On aetiological basis, Prameha is divided into two categories as Congenital (Prakrtija) and Acquired (Swakrta). The congenital type of Prameha is caused by hereditary and nonhereditary defects of the ovum and sperm. On the basis of pathophysiology, all types of Prameha are the results of vitiation of tridosha and they have been categorized according to the predominance of vitiated dosha and each sub type has been elaborated according to the characteristics of urine. Sleshamaja, Pittaja, and Vataja Prameha represent three clinical stages of renal damage. Sleshmaja Prameha is the initial stage, shere the function of kidney is impaired mildly. Pittaja Prameha, the second clinical stage of Prameha, shows moderately impaired renal functions and at the third clinical stage, the Vataja Prameha, renal functions are affected severely. Any disease, showing glycosuria may belong either to lkshumeha, Sitameha or Madhumeha. Diabetes Mellitus is a clinical syndrome, which runs through many types of Prameha beginning from Udakameha and terminating with Madhumeha. Majority of the aetiological factors of Prameha are scientifically proved as the aetiology of Diabetes Mellitus. Lkshymeha is characterized by excessive passing of sweet urine that is similar to juice of sugar cane. In Sitameha, patient passes large volume of cold, sweet urine. Madhumeha of Vataja Prameha excretes sweet urine in addition to the other characteristics of urine similar to bee-honey. These three conditions represent different stages of glycosuria. Accoding to modern pathophysiology, lkshumeha includes the conditions of glycosuria with mild to moderate polyuria. Diabetes Mellitus is the most common of the endocrine disorders. The term Diabetes Mellitus stands for a group of disorders defined by Hyperglycaemia. The elevation of blood glucose leads to the development of abnormalities in the metabolism of carbohydrates, proteins, lipids and electrolytes. In the longer term additional complications may arise as a result of dysfunction and failure in many organ systems. These complications include the permanent and irreversible changes in the Vascular system, nervous system, Genito-urinary system and in the eye. The two forms of Diabetes Mellitus are type 1, also known as Insulin Dependent Diabetes Mellitus (IDDM) and Type 2 or Non - Insulin Dependent Diabetes Mellitus (NIDDM). Hyperglycaemia in type 2 diabetic patients develops as a result of deficiency in insulin secretion or deficiency in the action of insulin due to the resistance. The stage of impaired glucose tolerance, which shows polyuria in spite of the absence of Glycosuria, can be included in Udakameha. The stage of impaired glucose tolerance, which shows polyuria and Glycosuria, can be included in lkshumeha. The stage of impaired glucose tolerance, which shows polyuria, glycosuria and albuminuria can be included in Sandrameha and so forth. Thus, the deficiency of insulin and insulin resistance are the two main causes of lkshumeha, and further , it can be classified as follows; lkshumeha 1 - Diabetes Mellitus Type 1, which shows gycoseuria with mild to moderate polyuria without severe renal damage. lkshumeha II- Diabetes Mellitus Type 2, wjich shows gycoseuria with mild to moderate polyuria, without severe renal damage. lkshumeha III - Glycosuria of mild renal diseases. lkshumeha IV - Gestational glycosuriaDiagnosis of Prameha, which depends on the clinical features and characteristics of urine, is made on following criteria at two occasions. * Appearance of premonitory symptoms and signsn with moderate polyuria .* Partial appearance of premonitory symptoms and signs with heavy polyuria. Diagnosis of Madhumeha is also made at the occasion of patient, who is affected with Prameha Pidaka showing the characteristics of complications. Clinical research on hyperglycaemic activity of DM - 13 in lkshumeha has not been conducted previously but many constituents of DM -13 had been investigated for their hypoglycaemic activity in animals and humans. According to the results of the present study, at the end of 14 days administration of DM - 13 71 percentage of patients of the test group has shown response to the treatment in lowering the Fasting Blood Glucose Level by 13.89 percentage in contrast to the control group whose fasting blood glucose level increases by 18.83 percentage. There is a significant decrease in the level of fasting blood glucose of test group after 14 days administration of DM - 13 compared to the level of fasting blood glucose of same group before the treatment. Fasting blood glucose level in control group is 21.27 percentage lower than that of test group (P\<0.001) before the treatment and fasting blood glucose level of test group is 9.11 percentage lower than that of control group at the end of 14 days treatment with DM-13. The effect of 14 days administration DM-13 on the levels of blood glucose after 30 minutes and 60 minutes of external glucose load, is statistically not significant. However, after 90 minutes and 120 minutes of external glucose load is significant at P\<0.001 and P=0.20 respectively, in contrast to the control group. These results suggest that oral administration of DM -13 for 14 days starts to improve the glucose tolerance. It is apparent that at the end of 60 days administration of DM-13 Fasting blood glucose level is significantly lowered (P\<0.001) in contrast to the control group. Oral administration of DM - 13 for 60 days has significantly (P\<0.001) improved the glucose tolerance. The test group has shown no significant change in serum lipid levels AST, ALT, GGT, and Alkaline Phosphatase in contrast to the control group.These results suggest that long term administration of DM-13 does not induce toxicity or hepatic damage and does not affect the lipid metabolism. Further, this evidence confirms that the long-term administration of DM -13 is more effective than the short-term. The hypoglycaemic effect of DM-13 may be resulted from alteration of many biological reactopms of human body and cannot be attributed to a single reaction. However, possible mechanism of DM-13 can be postulated according to the available information on each plant material. The roots of Coccinia indica is the mahor plant material of DM-13. Mukherjee et al. have confirmed the blood sugar lowering effect of Coccinia indica root in different experimental rat models. Kundu and Roy have identified Triterpinoids from root of Coccinia indica . Vaishnav, M.m. and K.R. Gupta identified a new saponin and a new furanoside: Ombuin 3-0-arabinofuranoside from Coccinia indica roots. Probably these chemicals may play the role in glucose lowering effect of Coccinia indica. Earlier nreport of Lal and Choudhuri has suggested an antihyperglycaemic effect of Syzygium cumini. Therefore, it may also have partly contributed for hypoglycaemic effect of DM-13. Dinneennet al. have shown that the majority of glucose entering the circulation in the fasting state is synthesized in the liver from the breakdown of glycogen (Glycogenolysis)and the formation of new glucose molecules (Glyconeogenesis). DM-13 has shown significant effect in lowering the fasting blood glucose level and improvement in the glucose tolerance. These results suggest that DM -13 may possess an effect on gluconeogenesis in the liver and improve the effect of insulin by augmenting the secretion of insulin from pancreatic á cells or reducing the resistance to the action of insulin at the target tissues. According to the study conducted by Saleem etal., Fruits of Terminalia chebula have shown stronger antioxidant action than alpha-tocopherol. Probably the antioxidant activity of Terminalia chebula of DM-13 may be responsible for the clinical improvement of diabetes mellitus Type 2 patients. Thakur, etal. Have confirmed the effect of Terminalia chebula, Emblica officinalis and Terminalia belarica in reducing serum cholesterol, aortic sudanophilia, cholesterol contents of the liver and aorta and the effect terminalia, chebula is greater than that of other two species. However, according to the present study DM-13 does not show significant alteration of serum lipid levels in lkshumeha (Diabetes Mellitus Type 2) patients. Sometimes this effect may be due to the antagonism of other chemical constituents of the decoction. On the basis of clinical observations it was apparent that majority of patients who received DM-13 has clinically improved in contrast to the control group regardless of the lowering of blood gluclse levels. 83 percentage of patients have shown decrease in the frequency of passing urine, lassitude, numbness of extremities and muscle pain. It suggests that DM-13 may possess other effects such as antioxidant activity, in addition to the hypoglycaemic effect. Therefore, DM-13 can be recommended for the management of lkshimha (Hyperglycaemia in Diabetes Mellitus Type 2 patients, who are not affected with renal damage.)