MONTH: JULY: AUG:2015 VOLUME: 3, ISSUE: 2 ISSN: 2348-1846 TITLE CLINICAL EVALUATION OF VIRECANA KARMA AND ORAL HYPOGLYCEMIC AGENT IN THE MANAGEMENT OF PRAMEHA W.S.R TYPE-2 DIABETES AGARWAL PRATEEK, SIPIKA SWATI , V.K SRIVASTAVA, DHIRAJ KISHORE PunarnaV ISSN: 2348 1846 AN INTERNATIONAL PEER REVIEWED AYURVED JOURNAL CLINICAL EVALUATION OF VIRECANA KARMA AND ORAL HYPOGLYCEMIC AGENT IN THE MANAGEMENT OF PRAMEHA W.S.R TYPE2 DIABETES AGARWAL PRATEEK 1, SIPIKA SWATI 2, V.K SRIVASTAVA3, DHIRAJ KISHORE4 1 JR-3 Department of Kayachikitsa, 2JR-3 Department of Stree Avum Prasuti Tantra , Assistant Professor Department of Kayachikitsa, 4Assistant Professor Department of Medicine Faculty of Medicine IMS,BHU, India. 3 ABSTRACT: Diabetes Mellitus (DM) refers to a group of common metabolic disorders that share the phenotype of hyperglycemia. Depending on the aetiology of the DM factors contributing hyperglycemia reduced insulin decreased glucose VIRECANAtoKARMA & ORAL include HYPOGLYCEMIC AGENTsecretion, IN THE MANAGEMENT OF utilization, and increasedPRAMEHA glucose production. DM-2 is a heterogenous group of W.S.R TYPE-2 DIABETES disorders characterized by variable degree of insulin resistance, impaired insulin secretion, and increased glucose production. The Ayurvedic texts reflect two major categories of Prameha 1. Sahaja Prameha 2. Apathyanimittaja Prameha, out of these two, Apathya nimittaja Prameha is closely resemblance with the contemporary concepts of Type-2 Diabetes mellitus. In modern medicine many oral hypoglycemic agents (OHA) has been used to control blood sugar level. Inspite of meticulous use of OHA, in many cases complications develop and there is no satisfactory control over blood sugar. In Ayurveda, samsodhan therapy has been said before samana to cure diseases. Thus in this study, Virecana Karma has been done either before or with OHA to control hyperglycemic state and its complications. KEY WORDS: Diabetes Mellitus, Prameha, Samshodhan, Samana,Virecana INTRODUCTION CORRESPONDANT: DR. AGARWAL PRATEEK JR-3 Department of Medicine Faculty of Medicine IMS,BHU, India. PUNARNAV :JULY :AUG 2015: VOL: 3 ISSUES: 2 Diabetes is associated with reduced life expectancy, significant morbidity due to specific diabetes related microvascular complications like retinopathy, neuropathy, nephropathy etc and increased risk of macrovascular complications i.e Page No: 01 VIRECANA KARMA & ORAL HYPOGLYCEMIC AGENT IN THE MANAGEMENT OF PRAMEHA W.S.R TYPE-2 DIABETES ischemic heart disease, stroke and in hepatic glucose production lead to overt peripheral vascular disease and diminished diabetes quality Ultimately, beta cell failure may ensue. of life. The metabolic with fasting hyperglycemia. dysregulation associated with DM causes Caraka has given exhaustive description secondary pathophysiologic changes in of the disease Prameha which ultimately multiple organ systems that impose a progresses towards Madhumeha or the tremendous burden on the individual with sweetness of urine in addition to Polyurea. diabetes and on the health economy. It is worth mentioning that Virecana Type 2 DM is characterized by Karma, unlike the modern purgatives, is pathophysiologic abnormalities: not merely an act to open the bowel, but is impaired insulin secretion, peripheral a complete therapeutic measure which has insulin resistance, and excessive hepatic systemic as well as local effects. Virecana glucose production. Obesity, particularly Karma is considered the best treatment for visceral or central, is very common in type morbid and increased Pitta dosha. Pitta is 2 DM. Insulin resistance associated with closely related with Agni, which is obesity genetically responsible for the digestive and metabolic determined insulin resistance of type 2 processes in the body. Diabetes is a DM. Adipocytes secrete a number of metabolic disorder hence Virecana karma biologic products (leptin, tumor necrosis has beneficial effect. Nowadays, Diabetes factor, free fatty acids) that modulate Mellitus is becoming a great problem for processes such as insulin secretion, insulin society causing impediment in normal life. action may In present research work, an attempt is contribute to the insulin resistance. In the made to adjuvant effect of OHA by early stages of the disorder, glucose planning Virecana karma either before or tolerance remains normal, despite insulin with it. three augments and body the weight and resistance, because the pancreatic beta cells compensate by increasing insulin output. As insulin resistance and AIMS AND OBJECTIVES 1. To reflect an over view on the compensatory hyperinsulinemia progress, concept of Prameha w.s.r to type 2 the pancreatic islets become unable to diabetes. sustain the hyperinsulinemic state. 2. To evalvuate the synergistic effect Impaired glucose tolerance marked by of Virecana Karma with OHA on elevations in postprandial glucose, and subjective then type 2 DM develops. A further parameters. decline in insulin secretion and an increase PUNARNAV :JULY :AUG 2015: VOL: 3 ISSUES: 2 PAGE: and objectives MATERIAL & METHOD Page No: 02 VIRECANA KARMA & ORAL HYPOGLYCEMIC AGENT IN THE MANAGEMENT OF PRAMEHA W.S.R TYPE-2 DIABETES • SELECTION OF CASES Cases of DM-2 were selected randomly from OPD and IPD of Type 2 Diabetes Mellitus with complications. • Type 1 Diabetes Kayacikitsa(Panchkarma), S. S. Hospital, associated IMS, B.H.U., Varanasi from august 2013 complications. to September 2014 after thorough history taking, clinical and laboratory • with and Phaeochromocytoma, Acromegaly, Cushing’s syndrome, hyperthyroidism etc. DIAGNOSTIC CRITERIA Patients of different age group, sex and • Drug or chemical induced diabetes socio-economic status were selected from mellitus e.g. the Kayachikitsa (Panchkarma) OPD & Thyroid hormone, IPD, S.S. Hospital, IMS, BHU, on the Phenytoin etc. basis of following criteria. • Thiazides, genetic syndromes mellitus e.g. Down’s syndrome, •Age 30-60 yrs. History Certain Glucocorticoids, sometimes associated with diabetes INCLUSION CRITERIA •Family without Diabetes due to endocrinopathies e.g. examination.. Mellitus Klinefelter’s syndrome, Turner’s of Diabetes, HTN, Dyslipidemia syndrome etc. • Patients suffering from any severe •Plasma glucose level: systemic disease. Fasting: ≥ 126 mg/dl • Patient having fasting blood glucose level ≥ 250mg/dl and pp Postprandial: ≥ 200 mg/dl blood sugar ≥350. HbA1c: ≥ 6.5% INVESTIGATION BMI: 18.5 – 29.9 1. •Patients having classical symptom of Blood Examination Routine blood was examined for total leukocyte count, differential leucocytes diseases without marked weight loss. count, hemoglobin percentage and EXCLUSION CRITERIA • erythrocyte sedimentation rate to exclude any infection. Age <30yrs. and >60yrs. PUNARNAV :JULY :AUG 2015: VOL: 3 ISSUES: 2 PAGE: Page No: 03 VIRECANA KARMA & ORAL HYPOGLYCEMIC AGENT IN THE MANAGEMENT OF PRAMEHA W.S.R TYPE-2 DIABETES Blood urea and serum creatinine were a prepared protocol to assess the done to assess the renal status. therapeutic response of trial treatment. Liver function test. The clinical gradations of symptoms were Urine Examination as follows. Urine for each case was examined 0 : No symptom present. 1 : Mild symptoms present. microscopic examination for crystals, casts 2 : Moderate and cells. present Study design and treatment schedule 3 : Severe symptoms present. 2. for specific albumin gravity, and acetone reaction, sugar, routinely and A total 20 patients with evidence of symptoms OBJECTIVE ASSESSMENT DM-2 and fulfilling the proposed criteria of selection were enrolled for clinical trial. Objective assessment was done on the following basis All 20 cases will be treated with Weight BMI (body mass index) Fasting blood Glucose Postprandial blood Glucose The assessment of the treatment Serum Cholesterol was based on both subjective and objective Serum Triglyceride parameters. Serum LDL HbA1c Virecana Karma with Trivritadi Leham (50gm) along with OHA as per need. ASSESSMENT CRITERIA SUBJECTIVE ASSESSMENT FOLLOW UP STUDIES This completely depends upon the symptomatology and its grades. Improvement in symptoms is directly proportional to the improvement in the patient’s condition and his metabolic state. To assess the subjective features of DM-2, the clinical symptomatology was graded into four grades (0-3) scale on the basis of severity and duration. The changes in the gradations of each symptom were noted on PUNARNAV :JULY :AUG 2015: VOL: 3 ISSUES: 2 PAGE: After the initial registration and basal study, all the patients were recruited randomly in respective trial groups and given the treatment regularly as per schedule. They were advised to come after 1 month interval for the assessment of therapeutic response. Total duration of study was 90 days. For each follow up of 30 days, the patients were assessed for clinical symptoms, including physical Page No: 04 VIRECANA KARMA & ORAL HYPOGLYCEMIC AGENT IN THE MANAGEMENT OF PRAMEHA W.S.R TYPE-2 DIABETES examination; Estimation of blood sugar Triglyceride & Sr. LDL were assessed (Fasting and Postprandial) and status of before and after the treatment. HbA1c, I. Therapeutic Studies and Clinical Trial BMI, Sr. Cholesterol, Sr. Table 1: Polydipsia No. of Cases (%age) Group Group (n=20) Grade BT 0 1 2 3 3 6 7 4 F1 Grade BT Group (n=20) 0 1 2 3 2 8 6 4 Group (n=20) Group Group (n=20) Grade BT 0 1 2 3 2 6 9 3 F3 6 13 18 9 6 2 5 1 0 0 0 0 Table 2: Burning sensation No. of Cases (%age) Group Group F2 F1 F2 F3 3 8 10 10 7 2 0 0 Table 3: Weakness No. of Cases (%age) F1 F2 14 5 1 0 13 7 0 0 Grade BT F1 F2 F3 0 1 2 3 2 5 9 4 3 8 7 2 5 13 2 0 13 7 0 0 2 =39.61 p<0.001 HS Within the group comparison (Friedman Chisquare) χ2=29.20 p<0.001 NS Within the group comparison (Friedman Chi-square) F3 4 4 8 14 8 2 0 0 Table 4: Polyurea No. of Cases (%age) Within the group comparison (Friedman Chi-square) χ2=30.05 p<0.001 HS Within the group comparison (Friedman Chi-square) χ2=31.89 P<0.001 HS Table 5: Polyphagia No. of Cases (%age) Group Group Grade BT F1 F2 F3 0 0 5 11 16 PUNARNAV :JULY :AUG 2015: VOL: 3 ISSUES: 2 PAGE: Within the group comparison (Friedman Chisquare) χ2=40.10 Page No: 05 VIRECANA KARMA & ORAL HYPOGLYCEMIC AGENT IN THE MANAGEMENT OF PRAMEHA W.S.R TYPE-2 DIABETES (n=20) P<0.001 HS 1 7 9 7 4 2 7 6 2 0 3 6 0 0 0 Table 6 : Effect of treatment on Fasting Blood Sugar (n=20) FBS Mean SD Within the group comparison, BT FU1 FU2 FU3 Group Paired ‘t’ test, (BT - FU3) 106.60 35.61 197.15 121.60 97.35 90.55 Group t = 15.43 (n=20) 35.59 31.50 15.14 8.47 p < 0.001 HS Table 7 : Effect of treatment on Postprandial Blood Sugar (n=20) PPBS Mean SD Group Group (n=20) BT FU1 FU2 FU3 278.25 48.89 150.75 28.20 124.0 17.29 124.15 12.33 Within the group comparison, Paired ‘t’ test, (BT - FU3) 154.10 53.76 t = 12.81 p < 0.001 HS Table 8: Effect of treatment on Sr. Cholesterol Sr. Cholesterol Mean SD Group Group (n=20) BT AT 266.25 46.44 201.35 9.77 Within the group comparison, Paired ‘t’ test, (BT - AT) 64.8 42.48 t = 6.81 p < 0.001 HS Table 9: Effect of treatment on Sr. Triglyceride Sr. Triglyceride Mean SD Group BT AT Group (n=20) 214.75 33.10 158.4 9.6 PUNARNAV :JULY :AUG 2015: VOL: 3 ISSUES: 2 PAGE: Within the group comparison, Paired ‘t’ test, (BT - AT) 56.3 30.90 t =8.15 p < 0.001 HS Page No: 06 VIRECANA KARMA & ORAL HYPOGLYCEMIC AGENT IN THE MANAGEMENT OF PRAMEHA W.S.R TYPE-2 DIABETES Table 10 : Effect of Trial Treatment on Sr. LDL Sr. LDL Group BT AT Group (n=20) 182.25 29.66 128.4 7.81 Within the group comparison, Paired ‘t’ test, (BT - AT) 53.8 27.22 t = 8.84 p < 0.001 HS Table 11: Effect of Trial Treatment on HbA1c HbA1c Within the group comparison, Paired ‘t’ test, BT AT (BT - AT) 1.75 1.08 8.38 1.69 6.63 .899 t = 7.22 p < 0.001 HS Table 12 : Effect of treatment on BMI Within the group BMI Mean SD comparison, Paired ‘t’ test, BT AT (BT - AT) 2.58 .888 27.05 1.80 24.49 1.69 t = 12.98 p < 0.001 HS Group Group (n=20) Group Group (n=20) OBSERVATION & DISSCUSSION The majority of the patients were The present study shows that the registered with negative family history duration of illness in patients of DM-2, (68.33%). 31.67% of total cases had the 41.67% were newly diagnosed, 31.67% positive family history of diabetes in their had duration of illness > 3 years, 26.67% first degree relatives (Bijadosha). Besides, patients had duration of illness <3 years. In it was also observed that maximum no. of this, Incidence of clinical symptomatology DM-2 fall in Rasa dominant Dusya in patients of DM-2 revealed that the (58.33%) followed by Meda (41.67%). maximum number of patients (93.33%) This indicates that not only familial had Polydipsia followed by Polyurea, impact but other factors also kept in mind Burning sensation, Weakness (95.0%) and at the time of describing etiopathogenesis Polyphagia (96.67%). This refuse that the of diabetes. This view is very relevant to clinical features of DM-2 described in concepts of Prameha / Madhumeha of Ayurveda are very scientific & comparable Ayurveda. to the latest knowledge in this field. PUNARNAV :JULY :AUG 2015: VOL: 3 ISSUES: 2 PAGE: Page No: 07 VIRECANA KARMA & ORAL HYPOGLYCEMIC AGENT IN THE MANAGEMENT OF PRAMEHA W.S.R TYPE-2 DIABETES The changes of BMI were This indicates that Virecana karma statistically highly significant (P<0.001). along with OHA measures we can well Virecana karma & OHA had showed a control blood sugar level and improves the good degree of difference in BMI level clinical symptoms along with weight loss. (2.58 .888), this indicates that not only Besides this it is also interesting to familial impact but other factors also kept note that probably Virecana karma cleans in mind at the time of describing the etiopathogenesis of diabetes. This view is mobilization of blood sugar from central to very relevant to concepts of Prameha / peripheral compartment Madhumeha of Ayurveda. decreasing insulin While studying body weight of the body channel and enhances either resistance or by by increasing insulin secretion due to which patients it was found that most of them there is decrement in the dose of OHA. were having weight 71-80 kg (35%) Lipid Profile followed by 61-70 kg (31.67%).This is the In the present study the serum strong evidence for the obesity as a factor cholesterol, serum triglyceride & serum for DM-2. Body mass index was also LDL level of patients showed highly calculated to identify the exact level of significant changes (P < 0.001) due to obesity and it was found that maximum Virecana karma & OHA. This study patients (44%) were registered as normal reveals that the trial treatment have (18.5-24.9 kg/m2) followed by 37.33% in tendency to reduce Serum Cholesterol & over weight category (25.0-29.9 kg/m2) Serum TG level in patients Type-2 DM, and 18.67% patient were registered under which is not possible only with the help of obese category (30.0 – 39.9 kg/m2) only OHA. Fasting Blood Sugar HbA1c In this series the mean reduction in In the present study, HbA1c shows fasting blood sugar was found to be difference of (1.75 1.08) BT to AT. So it statistically absolute shows that Virecana karma with OHA changes in fasting blood sugar was (106.60 measure can maintain blood sugar level for 35.61) (p<0.001). long term. Postprandial Blood Sugar Safety Profile significant. The The mean reduction in PP blood For the safety profile of the patients, we was highly have done Serum Creatinine & Blood significant. The absolute fall in PP blood Urea, LFT, CBC, ECG and CXR before & sugar was 154.10 53.76 (P < 0.001) after treatment & we did not get any sugar found statistically unwanted effect on the major metabolic PUNARNAV :JULY :AUG 2015: VOL: 3 ISSUES: 2 PAGE: Page No: 08 VIRECANA KARMA & ORAL HYPOGLYCEMIC AGENT IN THE MANAGEMENT OF PRAMEHA W.S.R TYPE-2 DIABETES organs of the body. Therefore this is (2) Local Evacuant : Which is suggesting that selected Virecana karma concerned with the evacuation of measures were safe in regards to renal these Dosha in form of Mala from function, liver function & cardiac function. the gut by Purgation. Probable Mode of action of Virecana As said by Acharya Sushruta in karma the patients of madhumeha, kapha and Action of Virecana Karma can be divided pitta are vitiated excessively and they in the following two ways. remain in the lower part of the body. Virecana karma is the best therapy to (1) Systemic - by which it brings down the morbid Dosha, particularly Pitta from the body to Amasaya or eliminate doshas from the lower part of the body and it also eliminate both kapha and pitta. Pakvasaya i.e. GIT. CONCLUSION With the help of Virecana karma Prameha. In Ayurveda, Vyadhi Kriyakala & OHA not only blood sugar level described by Sushruta gives an idea about decrease in Type-2 DM but lipid profile, the consecutive stages of the disease and BMI & clinical symptoms also improved accordingly management measures can be which is not possible only with OHA. This contemplated to control DM-2 & also to suggested the selected Virecana karma overcome complications. Early diagnosis measures cleans the body channels and of disease helps to cure the disease potentiate the peripheral utilization of successfully glucose and due to peripheral utilization of Vyaktavastha stage of Kriyakala represents glucose automatically symptomatic stage which indicates the improved. The patients who were taking presence of disease. So prescription of OHA after medication in the form of Virechan karma performing Virecana karma in classical and OHA is more important for controlling manner need less dose of OHA to achieve the disease process and stop its progress desirable blood glucose level in both further to complication stages. lipid profile initially in higher dose fasting and post prandial states along with good control on dyslipdemia. without its progression. In this study, the selected Virecana karma and OHA not only have The Present study reveals that encouraging results in terms of well Type-2 DM was well conceived in control blood sugar level along with Ayurvedic lexicons in the context of weight loss but also seems to be helpful to PUNARNAV :JULY :AUG 2015: VOL: 3 ISSUES: 2 PAGE: Page No: 09 VIRECANA KARMA & ORAL HYPOGLYCEMIC AGENT IN THE MANAGEMENT OF PRAMEHA W.S.R TYPE-2 DIABETES check the complications in Type-2 DM by Thus, this approach of Ayurvedic classics controlling dyslipidemia. Besides, this have significant preventive & curative role studies also overview that if Virecana in DM-2. The leads available from this karma and OHA applying in DM-2, it work open new Ayurveda-inspired holistic normalise the blood sugar and also cut off approach to the management of Type 2 its progression to insulin dependence. Diabetes Mellitus. REFFRENCES 1. Harrison’s : Principle of Internal Medicine, edited Braunwald, Stephen by Eugene L. Chaukhamba Surbharati Prakashan, Varanasi Reprint edition, 1992. Hauser, Anthony S. Fauci, Dan L. Longo, Dennis L. Kasper, J. Larry Jameson. Mc.GrawHill – Medical Publishing Division, 18th edi. 2. API Textbook of Medicine edited by Siddharth N. Shah, Publised by The Association of Physiations of India, 7th edi., revised reprint 2006. 3. Astanga Hridaya of Vagbhata with commentaries Sarvangasundra of Arundatta and Ayurveda Rasayana of Hemadri, Chowkhamba Prakashan, Varanasi, 1997. 4. Astanga Hridaya, edited by Prof. K.R. Srikantha Murty, Krishnadas Academy, Varanasi, IIIrd edi., 2000 5. Dravya Guna Vijana by P.V. Sharma, Vol II, Chowkhamba Sanskrit Sansthan, 7th edi. 1999. 6. Sushruta Samhita edited by Prof. P.V. Sharma, Chaukhamba Vishwabharati, Varanasi, Istedi., 2001. 7. Charaka Samhita edited by Vaidya Jadavaji, Trikamji Acharya, , PUNARNAV :JULY :AUG 2015: VOL: 3 ISSUES: 2 PAGE: Page No: 10