HYPOGLYCEMIC POTENTIAL OF SOME INDIGENOUS COMPOUND DRUGS IN MADHUMEHA (NIDDM)

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1 WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES Vaibhav et al. SJIF Impact Factor Volume 5, Issue 6, Research Article ISSN HYPOGLYCEMIC POTENTIAL OF SOME INDIGENOUS COMPOUND DRUGS IN MADHUMEHA (NIDDM) Amit Vaibhav 1, O.P. Singh 2 and S.K. Tiwari 3 1 Ph.D Scholar, Department of Kaya Chikitsa, Faculty of Ayurveda, Institute of Medical Sciences, BHU, Varanasi, Uttar Pradesh, India. 2 Professor, Department of Kaya Chikitsa, Faculty of Ayurveda, Institute of Medical Sciences, BHU, Varanasi, Uttar Pradesh, India. 3 Ex. Professor, Department of Kaya Chikitsa, Faculty of Ayurveda, Institute of Medical Sciences, BHU, Varanasi, Uttar Pradesh, India. Article Received on 05 April 2016, Revised on 26 April 2016, Accepted on 16 May 2016 DOI: /wjpps *Corresponding Author Dr. Amit Vaibhav Ph.D Scholar, Department of Kaya Chikitsa, Faculty of Ayurveda, Institute of Medical Sciences, BHU, Varanasi, Uttar Pradesh, India. ABSTRACT Objective: The main objective of the present work to evaluate the Antidiabetic potential of some indigenous compound drugs in Madhumeha (NIDDM) patients. Methodology: In this present study, total 78 patients were randomly selected and divided into three groups having 26 patients in each group. In group A (Indigenous compound drugs- DIMIT Ghan Vati) 26 patients, Group B (Glimipride) 23 and in Group-3 (DIMIT Ghan Vati+ Glimipride) 20 patients completed all the three follow ups (15days) in the total duration of 45 days of study. Result: Statistical analysis showed better result in relieving the sign and symptoms of Madhumeha (NIDDM) in all three the groups. Conclusion: Firstly diagnosed patient who are asymptomatic, advised only for trial drug had responded better. Patients with mild symptoms responded excellently when trial drug administered with Glimipride (OHA). KEYWORDS: Madhumeha, NIDDM, DIMIT ghan vati, Glimipride. INTRODUCTION Diabetes mellitus is a medical disorder characterized by varying or persistent hyperglycemia (elevated blood sugar levels), especially after eating. [1] All types of diabetes mellitus share similar symptoms and complications at advanced stages. Hyperglycemia itself can lead to dehydration and ketoacidosis. [2] Longer-term complications include cardiovascular disease Vol 5, Issue 6,

2 (doubled risk), chronic renal failure (it is the main cause for dialysis), retinal damage which can lead to blindness, nerve damage which can lead to erectile dysfunction (impotence), gangrene with risk of amputation of toes, feet, and even legs. [3] The prevalence of both type of DM is increasing worldwide the number of people with diabetes type 2 is expected rise more rapidly in future due to population growth, aging, increasing prevalence of obesity and physical inactivity. [4] The IDA has released estimates of the numbers of people with diabetes for 2030 will be 334 million. Six out of 10 countries with the highest rates are Asian and India is one of them. [5] The present work incorporates study on Madhumeha a disease entity synonymously used with diabetes mellitus. The word Madhumeha is self explanatory, which means excessive sweet urination. Madhumeha has been described as a complicated stage or end stage of all the Prameha, or it may manifest as a single disease due to excessive vata vriddhi. [6] Avritta vatajanya Madhumeha may be purely type-2 Diabetes mellitus and dhatu kshya janya Madhumeha may be comparable to complicated type 2 Diabetes Mellitus. Three subtypes of Prameha Ikshumeha, Sheetmeha and Madhumeha all have sweetness of urine but Madhumeha has much more similarity with Diabetes Mellitus as the former two may be completely cured with treatment but not Madhumeha. [7] Currently, a number of anti-diabetic agents are available to control hyperglycemia but due to long term/life long application, their use is restricted because of the risk profile. [8][9] Ayurveda is the repository of safe and therapeutically officious remedies and Ayurvedic physicians handle diseases with great success. Ayurvedic recipes are formulated only after centuries of trial and experience, and these are well known to be free from toxicity. Keeping above view in the mind we have been conducted clinical study on the patients of diabetes mellitus type II diagnosed clinically as well as on laboratory basis to evaluate the role of five well known hypoglycemic herbal entity Bilva, Guduchi, Tulsi, Fruits of Paneer plant and Bogainvillia in a single compound form (DIMIT ghan vati). MATERIALS AND METHODS A series of 78 cases of diabetes mellitus were selected from the O.P.D. and I.P.D. of Department of Kayachikitsa, S.S Hospital, Varanasi, U.P. Some of these cases were known diabetics while some were diagnosed for the first time, when they came with other complaints. Some cases were hospitalized but most cases were registered as OPD patients. Vol 5, Issue 6,

3 The study was undertaken in duration of August 2007 to December The study was carried out at Department of Kayachikitsa, Institute of Medical Sciences, Banaras Hindu University, Varanasi. Prior to the study, the approval of the institutional ethical committee was obtained. Patients were randomly divided into three groups, 26 patients in each group with care of inclusion and exclusion criteria has been taken, out of 78 patient of them 9 patient were dropped in middle of the trial period and 69 patients completed 45 days of total duration of treatment. Before registration, informed consent has been taken and proper confidentiality has also being maintained regarding sensitive issue, privacy and safety of the subjects throughout the trial. The cases were recorded with the help of a special proforma prepared for this purpose. For this clinical study 69 patients were divided into three groups. First group being only pure drug group second group was known as O.H.A. (Glimipride) drug group and third group included OHA along with trial drug The case selection was regardless of sex, occupation and socio-economic status. Inclusion criteria for patients of Type II diabetes, according to new diagnostic criteria given by WHO and the classical ayurvedic clinical feature of Madhumeha described by Charaka also taken into the account in the same manner. Inclusion criteria: (for type-ii diabetes mellitus) Inclusion criteria for patients of Type II diabetes, adopted from new diagnostic criteria given by WHO [10][11] is as follows: 1. Patients having classical symptoms of diabetes with causal plasma glucose > 200 mg/dl (< 400mg/dl) 2. Increased fasting blood Glucose > 126 mg/dl, more than two occasions in different days (< 250 mg/dl). 3. Increased post-prandial plasma Glucose > 200 mg/dl (< 350 mg/dl). 4. An HbA1c (Glycosylated Haemoglobin) level of 6.5% or more. A patient fulfilling any two of the above these criteria were confirmed having diabetes. Exclusion criteria 1. All type I or IDDM cases. 2. Cases with complication of the disease or having other associated diseases like T.B. or any acute infections. 3. Cases were excluded from the study who developed complication during study. Vol 5, Issue 6,

4 4. Patients having FBS more than 250 mg/dl and PPBS more than 350 mg/dl. Termination criteria 1. Sudden deterioration in patients health during the period of study 2. Non compliance of the patient. Grouping of Patients Group I - Dimit Ghan Vati 1 gm TID is given with follow up of 15 days Internval. Group II- Tab Glimipride 1mg one times a day with water just before meal with follow-up of 15 days interval. Group III- Tab Glimipride 1mg one times a day with water just before meal. Dimit Ghan Vati 1 gm TID is given with follow-up of 15 day interval Preparation of Trial Drug Dimit Ghan Vati The trial drug compound, named as "Dimit Ghan Vati" consists of equal amount of Bogainvillea Patra, Bilva patra, Fruits of Paneer plant and Guduchi Kanda. All these are converted into the form of Ghan after that it was bhavit (treated) with same amount of Tulsi patra swaras and made in vati form weighed 500 mg each. Bilwa Aegle marmelos (Linn.) Guduchi Tinospora cordifolia (Willd.) Hook. F. & Th. Tulasi Ocimum sanctum Linn. Bougainvillea Bougainvillea spectabilis Paneer Dodi Withania coagulans.dunal Vol 5, Issue 6,

5 Treatment schedule In Group I and Group III both type of patients, the dose was decided 3 gram/day in three divided doses of 1 gm once or two Vati each time after meal. The group II patient only treated with Standard Oral hypoglycemic agent Glimipride 1mg one times a day just before meal and Group III patient also received same dose of Glimipride along with Dimit Ghan Vati. Statistical Analysis The data obtained was processed on a computer with the help of SPSS: 10 software package of statistical analysis. Standard statistical methods were used to determine the mean, standard deviation (SD) and the range. Paired t-test was used to compare the results of various biochemical parameters among the patients in the four groups. All value quoted as the mean ± SD and a p-value of < 0.05 was considered to be statistically significant and p- value of <0.01 or p < was considered to be statistically highly significant. Clinical Assessment of the Disease All cases to be registered were subjected for their detailed examination after history taking as per following points - 1) Chief complaints with duration. 2) History of Past illness 3) Treatment history. 4) Family history of relevance of disease. 5) Personal history - appetite, diet, sleep, maturation, bowel habit and addiction. Laboratory Parameter 1) Blood Sugar Fasting (FBS.) 2) Blood Sugar Postprandial (PPBS) 3) HbA1C Vol 5, Issue 6,

6 Blood samples of group I, II & III patients were collected by venipuncture from a peripheral vein in plain vials, after each follow up. OBSERVATION AND RESULT Table 1: Showing the statistical results of the parameters of Group-I [n=26] Parameters Blood Sugar Fasting (FBS.) [mg/dl] Blood Sugar Postprandial (PPBS) [mg/dl] HbA1C [IU] B.T FU FU FU [B.T=Before treatment, FU- Follow up, A.T=After treatment, S.D=Standard deviation]. With in the group comparison, paired 't' test (B.T-FU3) t = 3.83 p< t = 7.13 p< t = 2.76 p< 0.05 Table-1 shows mean and standard deviation of Fasting Blood Sugar (FBS.), Postprandial Blood Sugar (PPBS) and HbA1C levels after each follow up treated by DIMIT Ghan Vati (3gm/day). Parameters Blood Sugar Fasting (FBS.) [mg/dl] Blood Sugar Postprandial (PPBS) [mg/dl] HbA1C [IU] Table 2: Showing the statistical results of the parameters of Group-II [n-23] B.T FU 1 FU 2 FU [B.T=Before treatment, FU- Follow up, A.T=After treatment, S.D=Standard deviation]. With in the group comparison, paired 't' test (B.T-FU3) t = 8.74 p< t = 5.10 p< t = 1.98 p> 0.05 Table-2 shows mean and standard deviation of Fasting Blood Sugar (FBS.), Postprandial Blood Sugar (PPBS) and HbA1C levels after each follow up treated by Tab Glimipride (1 mg/day). Vol 5, Issue 6,

7 Table 3: Showing the statistical results of the parameters of Group-III [n-20] Parameters Blood Sugar Fasting (FBS.) [mg/dl] Blood Sugar Postprandial (PPBS) [mg/dl] HbA1C [IU] B.T FU FU FU With in the group comparison, paired 't' test (B.T-FU3) t = 4.86 p< t =5.37 p< t = 2.74 p< 0.05 [B.T=Before treatment, FU- Follow up, A.T=After treatment, S.D=Standard deviation] Table-3 shows mean and standard deviation of Fasting Blood Sugar (FBS.), Postprandial Blood Sugar (PPBS) and HbA1C levels after each follow up treated by both DIMIT Ghan Vati (3gm/day) and Tab Glimipride (1 mg/day). DISCUSSION The patients of Group III (OHA + Trial drug) and Group II ( Only OHA) having approximately same significant improvement in fasting blood sugar level ( p<0.001, mean + S.D and p<0.001, mean + S.D respectively) and only significant improvement noted in Group I ( Trial Drug group) - p<0.05, mean + S.D All above result show efficacy of Dimit Ghan Vati in Lowering FBS level but it exerts better effect when it combine with OHA. The patient of all Group I,II and III show a high significant improvement in post prandial blood sugar level (p<0.001). Mean + S.D values for Group I, II and III Groups are respectively , and these data suggest that there are more or less equal improvement noted in Trial drug Group(I) and Trial + OHA drug Group (III) in Blood Post prandial sugar level. Between the group comparison, There were equal response noted in all three groups (p>0.05), there is no significant difference in rate of improvement between the groups. Glycosylated Hb (HbAIC ) also showed the significant improvement in I and III (p< 0.05) groups with no significant difference in the rate of improvement between all the group. The trial drug for the study was a Ghan Vati named as ' Dimit Ghan Vati' and its comparison with a Standard oral hypoglycemic agent (Glimipride). It consists of dry aqueous extracts of leaves of five well proven anti-diabetic drugs as Guduchi Kanda, Bilwa Patra, Tulsi Patra, Vol 5, Issue 6,

8 Fruits of Paneer Plant (Rishyagandha) and Leafs of Bougainvillia in equal amounts. The object was to observe the synergistic effect of these drugs and to prepare a potent antidiabetic drug which may act in almost all prospective of glucose metabolism. Aquas and Alcoholic extract of Guduchi contains some alkaloid, which has proved more potent hypoglycemic effect [14][15] in alloxane induced hyperglycemic rates.ethanolic and aquaous both extract of Bilwa patra have given hypoglycemic effect [12][13] on experiments. Ethanolic extract of Tulasi leaves also have shown hypoglycemic effect [16][17] in rates. Ethanolic and aqueous both extract of Bilwa patra have given hypoglycemic effect on experiments. Fruits of Doda Paneer (Rishyagandha) Contain Withanoide having potent action on both fasting and post prandial blood sugar in type- II Diabetic patient [22][23] and the leaves of Bougainvillea Spectabilis contain D- Pinitol [18][19] is claimed to exert insulin like effects [20][21] in streptozocine induced rats and human subject. The drugs used are Tikta, Kashaya and Katu Rasa predominant, Katu in Vipaka and Ushna in Virya. All above described Guna is responsible for Shamana of vitiated Kapha and Medodhatu, which are the main factors in the pathogenesis of Madhumeha. CONCLUSIONS The whole above description may be concluded as it is suggesting the five well proved hypoglycemic herbal drugs in the form of Dimit Ghan vati has significant improvement in all prospective of symptoms with lab investigations of Group I patients and It exerts high significant results when combine with a standard OHA (Glimipride) as in Group III i.e. Patients with mild symptoms responded excellently when trial drug administered with Glimipride (OHA). So it may be possible that there is some sort of synergism in between Dimit Ghan Vati and OHA (Glimipride) when they use together. ACKNOWLEDGMENT Our sincere thanks to everyone who have helped us during the course of our research study including all teachers, staffs members, post graduate students and technical persons of Department of Kayachikitsa, Dean faculty of Ayurveda and Director of IMS, BHU. Finally, our thanks to all patients and attendant who were part of the study for their kind cooperation. REFERENCES 1. "About diabetes". World Health Organization. Retrieved 4 April "Diabetes Fact sheet N 312". WHO. October Retrieved 25 March Vol 5, Issue 6,

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