Metformin Tablets Research Articles

Latest Advancements on Gastro Floating Bi-Layer Tablets of Metformin and Pioglitazone for the Treatment of Diabetes Mellitus

The synergistic mode of action of pioglitazone hydrochloride (PG) and metformin hydrochloride (MH) has great potential for the treatment of type 2 diabetes mellitus. Because of their complementary modes of action, metformin hydrochloride (MH) and pioglitazone hydrochloride (PG) have great potential for the therapy of type 2 diabetes mellitus. Short half-life and the low absorption of metformin hydrochloride in lower gastrointestinal tract might restrict the action towards its expected therapeutic usefulness. This work aimed to create gastro-floating bilayer matrix tablets that would each contain two different drugs. The primary objective was to improve the absorption of pioglitazone hydrochloride through rapid release, while ensuring a sustained release of metformin hydrochloride. After optimisation, with a floating lag time of five minutes, the tablets floated in the testing medium for over twenty-four hours. They allowed the active substance to be released within 12 hours using a diffusion-dependent release mechanism with total release of the active substance being achieved within 5 minutes. Furthermore, it was viewed that, metformin hydrochloride yielded a stable plasma concentration, bio-availability increased by 1.5 times, Cmax decrease and Tmax was reduced. Furthermore, pioglitazone hydrochloride's in vivo behaviour matched that of the approved product. In addition to having improved mechanical and physical qualities, all formulations had a pleasing appearance. Stability testing and infrared spectroscopy analysis were done on the formulation, and the results showed that it produced the best results in terms of drug release and duration of buoyancy in vitro. The findings suggest that the medication and polymer did not interact chemically and that the formulation remained stable. The study finds that by achieving simultaneous sustained release of metformin hydrochloride with enhanced absorption and immediate release of pioglitazone hydrochloride, a gastro-floating bilayer tablet facilitated a more effective combination therapy for diabetes mellitus. The benefits of combining pioglitazone and metformin into a single tablet are reviewed in this review, with particular attention paid to how this combination may improve glycemic control, compliance, metabolic characteristics of people with type 2 diabetes mellitus.

Latest Advancements on Gastro Floating Bi-Layer Tablets of Metformin and Pioglitazone for the Treatment of Diabetes Mellitus

The synergistic mode of action of pioglitazone hydrochloride (PG) and metformin hydrochloride (MH) has great potential for the treatment of type 2 diabetes mellitus. Because of their complementary modes of action, metformin hydrochloride (MH) and pioglitazone hydrochloride (PG) have great potential for the therapy of type 2 diabetes mellitus. Short half-life and the low absorption of metformin hydrochloride in lower gastrointestinal tract might restrict the action towards its expected therapeutic usefulness. This work aimed to create gastro-floating bilayer matrix tablets that would each contain two different drugs. The primary objective was to improve the absorption of pioglitazone hydrochloride through rapid release, while ensuring a sustained release of metformin hydrochloride. After optimisation, with a floating lag time of five minutes, the tablets floated in the testing medium for over twenty-four hours. They allowed the active substance to be released within 12 hours using a diffusion-dependent release mechanism with total release of the active substance being achieved within 5 minutes. Furthermore, it was viewed that, metformin hydrochloride yielded a stable plasma concentration, bio-availability increased by 1.5 times, Cmax decrease and Tmax was reduced. Furthermore, pioglitazone hydrochloride's in vivo behaviour matched that of the approved product. In addition to having improved mechanical and physical qualities, all formulations had a pleasing appearance. Stability testing and infrared spectroscopy analysis were done on the formulation, and the results showed that it produced the best results in terms of drug release and duration of buoyancy in vitro. The findings suggest that the medication and polymer did not interact chemically and that the formulation remained stable. The study finds that by achieving simultaneous sustained release of metformin hydrochloride with enhanced absorption and immediate release of pioglitazone hydrochloride, a gastro-floating bilayer tablet facilitated a more effective combination therapy for diabetes mellitus. The benefits of combining pioglitazone and metformin into a single tablet are reviewed in this review, with particular attention paid to how this combination may improve glycemic control, compliance, metabolic characteristics of people with type 2 diabetes mellitus.

The Effect of Preoperative Metformin on Postoperative Hyperglycemia in Non-Diabetic Patients: A Randomized Clinical Trial

Background: Blood glucose control during surgery can decrease the infection, disability, and death rate. The purpose of this study was to determine the effect of preoperative metformin on blood glucose levels in nondiabetic orthopedic surgery. Methods: This clinical trial was conducted on 176 nondiabetic patients with ASA class I or II who were candidates for orthopedic surgery. The patients were randomly divided into two equal groups. The metformin group received 500 mg metformin tablet orally and the placebo group received placebo tablet 30 minutes before the surgery. Blood glucose was measured every 6-hour to 24 hours and blood urine nitrogen (BUN), creatinine was measured preoperatively and the day after surgery. The data was analyzed by SPSS v21 and P value<0.05 was significant. Results: Demographic characteristics such as age, sex and body mass index (BMI) had no significant difference in two groups. Creatinine and BUN were similar in two groups. Preoperative blood glucose was 101.8±22.6 mg/dl in the metformin group and 109.7±24.8 mg/dl in the control group without significant difference (p=0.08). However, BS at hours 6, 12, showed a significant difference between the two groups (p<0.001, 0.022) and then blood glucose was similar in two groups (0.8, 0.12 respectively). Conclusion: Preoperative metformin (500 mg) was effective for blood glucose control in nondiabetic patients undergoing orthopedic surgery. However, additional research is required to determine the efficacy of this therapy.

Comments on prescriptions of big data from outpatient and emergency services using R

Abstract. To explore the high-frequency influencing factors of unqualified prescriptions, and promote rational drug use, the author evaluated on prescriptions of 245,352 from outpatient and emergency services using R in a large 3A hospital in 2023. Among the 245,352 prescriptions, 1,327 were evaluated as unreasonable, with a percentage of 0.54%. There were 1,368 issues related to irrational drug usage. Among the irrational prescriptions identified, the most prominent issues were inappropriate indications (59.16%) and incomplete writing in clinical diagnosis (17.78%). The departments with relatively high rates included head and neck surgery (5.94%), general medicine (3.33%), and convenient outpatient service (2.02%). The top five drugs in irrational prescriptions were Atorvastatin calcium tablets, Aspirin enteric-coated tablets, Calcium carbonate D3 tablets, Rabeprazole sodium enteric-coated tablets, and Metformin tablets, which were commonly used in chronic diseases. There was no significant correlation between the irrational rate and the professional title of the prescribing doctor. Overall, the quality of prescriptions in the hospital was satisfied, but there were still cases of irrational drug use. Hospitals should strengthen prescription review and rational drug use management to ensure the safety and effectiveness of patient medication.

Formulation and Evaluation of Metformin Controlled Release Tablets Using Tamarind Seed Gum Powder as a Natural Polymer

Aim: This research aims to develop controlled-release tablets of metformin using tamarind seed gum powder as the matrix-forming agent. Methods: Tamarind seeds were thoroughly cleaned, boiled and dehulled manually to remove the seed coat. The dehulled seeds were then dried, ground into a fine powder and sieved using a 60-mesh screen. The resulting gum powder was purified and subjected to drying under controlled conditions to ensure its suitability for use as a polymer. Controlled-release tablets were prepared through direct compression. Tamarind seed gum powder was incorporated at varying concentrations (5%-20% w/w) to optimize the drug release profile. The evaluation of the tablets included both pre-compression and post-compression parameters. Results: The drug release profile of metformin from the tablets showed sustained release over a 12-hour period. Increasing the concentration of tamarind seed gum in the formulations led to a slower release rate, which can be attributed to the gum's ability to swell and form a gel-like matrix, thereby controlling the drug release. The optimized formulation best fit the Higuchi model, suggesting that diffusion was the predominant mechanism governing the release of metformin from the tablets. As the concentration of tamarind seed gum increases (from 5% to 20%), the rate of drug release decreases, showing a slower release over the 12-hour period. This can be explained by the enhanced gel formation and swelling capacity of tamarind seed gum, which restricts the diffusion of the drug. Tablets stored at 40°C/75% RH for three months showed no significant changes in drug release or physicochemical properties, confirming the stability of the formulation. Conclusion: Tamarind seed gum powder exhibits significant potential as a natural polymer for controlled-release formulations of metformin hydrochloride. This study underscores its ability to achieve sustained drug release, maintaining consistent pharmacokinetic profiles. The results support the development of cost-effective, biocompatible drug delivery systems that harness the benefits of natural resources, offering a sustainable alternative to synthetic polymers in pharmaceutical applications.

Efficacy of Alogliptin/Metformin Fixed-Dose Combination Tablets and Vildagliptin/Metformin Fixed-Dose Combination Tablets on Glycemic Control in Real-World Clinical Practice for the Patients with Type 2 Diabetes: A Multicenter, Open-Label, Randomized, Parallel Group, Comparative Trial.

Background: This study was aimed to compare the efficacy of two combination tablets of dipeptidyl peptidase-4 (DPP-4) inhibitors and metformin with different dosages, alogliptin/metformin (AM) and vildagliptin/metformin (VM), on glycemic control in patients with type 2 diabetes (T2D). Methods: This was a prospective, multicenter, open-label, randomized, parallel group, comparative trial. After a run-in period of treatment with metformin alone, a total of 59 Japanese outpatients with T2D, aged 20-79 years with glycated hemoglobin (HbA1c) levels of 6.5%-10% were randomly assigned to 12-week AM treatment, alogliptin 25 mg/metformin 500 mg combination tablet orally once a day, or VM treatment, vildagliptin 50 mg/metformin 250 mg combination tablet orally twice a day. The primary endpoints were the changes in HbA1c and fasting plasma glucose (FPG) levels from baseline to week 12 between the two groups. Blinded intermittently scanned continuous glucose monitoring (isCGM) was performed between weeks 10 and 12. The incidence of adverse events during the study was also evaluated. Results: In all, 52 participants were analyzed. Significant decreases in HbA1c and FPG levels from baseline to week 12 were observed in both treatment groups. However, there were no significant differences between the AM and VM groups in the change in HbA1c level (-0.3% and -0.4%, P = 0.309) or the FPG level (-9.0 and -15.0 mg/dL, P = 0.789). The isCGM revealed that both treatments achieved the recommended glycemic target range. No adverse events, such as severe hypoglycemia, were observed in either group. Conclusions: We concluded that there were no significant differences in the efficacy of two combination tablets of DPP-4 inhibitors and metformin with different dosages on glycemic control in patients with T2D.

Metformin reduces testosterone level in type 2 diabetes mellitus patients and its therapy by traditional medicine

Metformin reduces testosterone level in type 2 diabetes mellitus patients and its therapy by traditional medicine

Beyond the Obvious: Acanthosis Nigricans as a Clue to the Rare Case of Rabson–Mendenhall Syndrome

Rabson–Mendenhall syndrome (RMS) is a genetic disorder with autosomal recessive inheritance caused by mutations in the insulin receptor (INSR) gene. It is characterized by severe insulin resistance, acanthosis nigricans, skin tags, and growth retardation. Management of this condition is challenging and requires multidisciplinary approach. We present a case report on RMS in a 7-year-old girl who presented with coarse facies, acanthosis nigricans, skin tags, short stature, abdominal distension, and hyperglycemia with hyperinsulinemia. Her genetic analysis revealed a mutation in exon 3 of the INSR gene. The patient is being treated with tablet metformin and is being followed up.

Isolation and Characterization of Irvingia gabonensis Seed Contents and the Tableting Properties of its Gum Component

This experimental work was designed to isolate, purify and estimate the fatty acids contents of Irvingia gabonensis seeds (IGS) and to evaluate the tableting properties of the gum constituent of the seed in metformin tablet. A known amount of the IGS was crushed and dispersed in purified water at a temperature of 80oC, Ethanol (90 %) was added, filtered and dried at 40oC. The fatty acid components were recovered using petroleum ether, while the gum was further purified with ethanol (90%). The fatty acid contents obtained were analyzed using an Agilent G1701 GC/MSD system. The gum content was evaluated using parameters such as: flow rate, angle of repose, bulk and tapped density and Carr’s index. The gum was granulated with other excipients and metformin powder dried at 40oC. The granules were evaluated as was done for the gum and tablet compression done at 2.0 KN on a single punch tablet machine fitted with 12.5 mm diameter die size. The GC-MS revealed bioactive compounds mainly fatty acids– lauric acid (36.82%), myristic acid (31.52%), benzyl dodecanoate (9.06%) and palmitic acid (4.03%), n-decanoic acid, 1-(hydroxymethyl)-1,2-ethanediyl ester, tetradecanoic acid, 2-hydroxy-1,3-propanediyl ester, etc. The granule size distribution revealed size and compactness in the following order: Acacia gum > IGS-gum > Gelatin, and average granule size for the batches were found to be 500 μm. Evaluation of metformin tablets gave the following results: crushing strength, friability, and disintegration time for B7 and B8 (7.5 and 10 %w/v IGS-gum as binder) as 58 and 68 N, 1.03% and 1.01%, 20.00 and 26.00 min., respectively. B3and B4 (7.5 and 10 %w/v acacia were shown as gum as binder) 44 and 48 N, 1.10 and 1.03%, 20.00 and 23.50 min., respectively. It can be concluded that at 7.5 and 10 %w/v, IGS-gum proved to be a better binder than acacia in metformin tablets formulation. Dhaka Univ. J. Pharm. Sci. 23(1): 53-62, 2024 (June)

Metformin drugs under simulated gastric conditions can generate high nitrite-dependent levels of N-nitrosodimethylamine

N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), group 2A carcinogens, were detected in finished drug products, including metformin, ranitidine, sartans and other drugs which caused multiple recalls in the USA and Europe. Important studies also reported the formation of NDMA when ranitidine and nitrite were added to simulated gastric fluid. Our objective was to screen finished drug products from Europe and USA for nitrosamine impurities and investigate the formation of NDMA in metformin finished drug products when added to simulated gastric fluid. One dosage unit of 30 different commercially available drugs, including metformin, sartans, and ranitidine were tested for NDMA, NDEA, and dimethylformamide (DMF) impurities, using a liquid chromatography-mass spectrometry (LC–MS) method. Then, 6 metformin finished drug products were tested in stomach conditions for 2 h at 37 °C in a 100 mL solution with a pH of 2.5 and different nitrite concentrations (40, 10, 1, 0.1 mM) and tested for NDMA, and DMF using LC–MS. We measured NDMA, NDEA, and DMF in 30 finished drug products. NDMA and DMF were quantified for metformin drug products in simulated gastric fluid with different nitrite concentrations. None of the 30 drugs showed concerning levels of NDMA, NDEA, or DMF when tested as single tablets. However, when metformin tablets are added to simulated gastric fluid solutions with high nitrite concentrations (40 mM and 10 mM), NDMA can reach amounts of thousands of nanograms per tablet. At the closest concentration to physiologic conditions we used, 1 mM, NDMA is still present in the hundreds of nanograms in some metformin products. In this in vitro study, nitrite concentration had a very important effect on NDMA quantification in metformin tablets added to simulated gastric fluid. 1 mM nitrite caused an increase above the acceptable daily intake set by the U.S. Food and Drug Administration (FDA) for some of the metformin drugs. 10 mM, 40 mM nitrite solutions generated NDMA amounts exceeding by more than a hundred times the acceptable daily intake set by the FDA of 96 nanograms. These findings suggest that metformin can react with nitrite in gastric-like conditions and generate NDMA. Thus, patients taking metformin could be exposed to NDMA when high nitrite levels are present in their stomach, and we recommend including a statement within the Patient Package Inserts/Instructions for use.

Clinical assessment of the efficacy of Ayurvedic management in PCOS: Study protocol for a randomized open-label standard control trial

Abstract INTRODUCTION: Polycystic ovary syndrome (PCOS) is a heterogeneous disorder, typically characterized by anovulation, hormonal imbalances, obesity, infertility, and associated features, with a significant impact on the physiological and psychological wellbeing of females belonging to the reproductive age group. Due to the multifactorial etiology, treatment is often personalized with specific targets, and monotherapy is rarely used. In the present study, the efficacy of an Ayurveda regimen, comprising the Ayush-SSM tablet (a coded Ayurvedic formulation) administered after Virechana therapy (purgation), is being explored against conventional standard care. MATERIALS AND METHODS: This study is an open-label, randomized, controlled clinical trial consisting of 180 participants diagnosed with PCOS. The participants in the trial group will receive Ayurvedic treatment consisting of Virechana therapy followed by administration of Ayush-SSM (500 mg), two tablets twice a day for 6 months. The participants in the control group will receive metformin tablet 500 mg once a day in the first week, 500 mg twice a day in the second week, 500 mg thrice a day in the third week, and 850 mg twice a day from the fourth week till 6 months. The primary outcome is the proportion of study participants who attain normal menstrual cycle length (21–35 days) or ovulation and change in hirsutism as per the modified Ferriman–Gallwey (FG) Score. The secondary outcomes are change in acne score and acanthosis nigricans; change in abdominal girth, waist circumference, and BMI; and clinical safety of the trial interventions. CONCLUSION: The findings of the study could potentially demonstrate that the Ayurveda regimen, including Virechana therapy followed by administration of the Ayush-SSM tablet, may be as effective as conventional standard care. Trial registration: Clinical Trial Registry of India (CTRI/2022/09/045478, dated August 4, 2022).

Quality assessment of metformin hydrochloride tablets retailed in Lagos, Nigeria

Background: Metformin is a biguanide antihyperglycemic drug used with diet and exercise for glycemic control in type 2 diabetes mellitus.Objectives: This research aims to compare and analyze different metformin products to ascertain their critical quality parameters. The goal is to ensure that prescribed medicine effectively treats patients and protects the public.Materials and Methods: We evaluated the quality of ten metformin tablet brands in Lagos (Mushin and Surulere area) using official methods to assess weight, hardness, friability, disintegration time, and dissolution. Active ingredient content was also measured.Results: Out of all the tablets tested, only 10 % had weights outside of the official British Pharmacopoeia 2002 limits (not more than two tablets should deviate from ±5% and none of the tablets should deviate by ± I0). The hardness test was passed by all the tablets (A minimum hardness of 4 kgF is a pass), while 80 % passed the friability test (weight loss of ≤ 1 %w/w is a pass). Additionally, all film-coated tablets disintegrated within 30 minutes according to United States Pharmacopoeia/National Formulary 2003 (film-coated tablets disintegrate within 30 minutes). Ninety percent of the tablets passed the dissolution test (drug release within 60 minutes should be between 93 and 103 %) and 90 % of all brands examined passed the assay test for the active ingredient contents. The British Pharmacopoeia 2019 standard was used for the dissolution test.Conclusion: Routine pharmaceutical analysis is essential for the quality of pharmaceutical products and the safety of consumers.

Invitro evaluation of generic vs branded product of metformin tablet

The main aim and objective of present research work is to evaluate and compare the standards concerning quality of generic and branded anti hyperglycemic drug (Metformin Hcl). Metformin tablets are evaluated as per standard protocol and results shows that branded and generic meets the pharmacopoeial specifications. All tablets passed the test of weight variation, hardness, thickeness, friability, disintegration, dissolution and assay as per Indian pharmacopoeia. Both the generic and branded tablets of metformin shows similar results. So, health care professionals are suggested to prescribe generic drug so, that everyone can reach the cost of the drug and maintain good health.

Comparative study of Nishaamalaki and metformin in obese patients of type 2 diabetes mellitus (Madhumeha): A study protocol

Background Poor synthesis of insulin by beta cells present in the pancreas combined with resistance of insulin in peripheral organs is referred to as type 2 diabetes mellitus. Insulin resistance leads to an increase in plasma fatty acids, which reduces transfer of glucose within the cells of muscles and increases breakage of lipids, resulting in an increase in hepatic glucose production. Nishamalaki (a formulation of turmeric and Indian gooseberry) is suggested in the therapy of all kinds of Madhumeha (diabetes mellitus) in Ayurveda classics. Turmeric and Indian gooseberry are the two main ingredients. Both are considered as effective medicines in the management of Madhumeha individually as well as in combined form. Aim To compare the efficacy of Nishaamalaki and metformin in obese patients of type2 diabetes mellitus. Methods The study will include 60 obese type 2 diabetes mellitus patients who will be distributed into two distinct categories, each with 30 patients. Nishamalaki Churna 3gm two times a day before food with warm water for 60 days in Group N (Experimental Group) and 500 mg metformin tablets twice daily before meals for 60 days in Group M (Control Group). Every 15th day, an assessment will be made (15th, 30th, 45th and 60th day). Results Objective outcomes will be assessed. Conclusion Conclusion will be based on the data received after the completion of the study.

Application of the variability budget approach to the Dissolution test

The aim. This study aimed to evaluate the completeness of our knowledge about the sources of variation in the Dissolution test with 100 % release by compiling a variability budget.
 Materials and methods. The study was performed on 500 mg metformin tablets, using pharmacopoeial quality reagents, State Pharmacopoeia of Ukraine (SPhU) Metformin HCl reference standard, Pharmatest DT70 Dissolution apparatus, Perkin Elmer Lambda 35 spectrophotometer, Mettler Toledo XP 204 analytical balance, and ISO class A volumetric glassware. The SPhU metrological approach was employed.
 Results and discussion. The variability budget was compiled based on the comparison of uncertainty estimates obtained from the requirements for maximum permissible variation in normal analytical practice (UNAP, bottom-up estimation) and experimental data (Uexp). This involved characterizing Metformin content in tablets using the Uniformity of Dosage Units (UDU) test as an independent method. The 100 % release of Metformin in the Dissolution test (infinity point) was proved by increasing the dissolution time. Having optimized Dissolution and UDU analytical procedures for variability budget compiling, we achieved insignificance of Uexp compared to the target uncertainty (Utg) for the Dissolution test in compliance testing. The differences in UDU and Dissolution mean results did not exceed UNAP for the release time of 45 and 60 min, i.e. uncertainty budget was proven. Uexp for the Dissolution test indicated the presence of an unknown statistically significant source of random variation, which, however, was less than Utg; therefore, the procedure is suitable for compliance testing.
 Conclusion. Experimental results confirmed the completeness of our knowledge about sources of variation (absence of bias) for the Dissolution test with 100 % release. An essential condition for compiling the budget was the optimization of uncertainty of analytical procedures. For UDU, all significant sources of variation were within the expected range. Yet, there is a need for additional research to identify and manage an unknown source of practically significant random variation for the Dissolution test

Evaluation of Seven Different Brands of Metformin Hydrochloride Tablets Available in the Market in Gondar City, Ethiopia.

WHO estimates that 15.8% of substandard or falsified medical products are used to treat non-communicable diseases which account for 80% of the global burden including diabetes. The increased level of use of metformin hydrochloride tablets in clinical practice creates the need to monitor and ascertain the quality of the various brands available in the drug market for quality control assessment and generic substitution. This study aims to assess the pharmaceutical quality of seven brands of metformin tablets circulating in pharmacy outlets in Gondar City, North West Ethiopia. Official Pharmacopoeia tests such as uniformity of weight, disintegration, assay, and dissolution tests were used to assess the physicochemical quality control parameters of metformin hydrochloride tablet brands. The unofficial tests conducted included crushing strength/hardness and friability. In all seven tests, the tested brands passed the BP official tests for uniformity of weight, friability, disintegration, and dissolution. Each product had a friability of less than 1% with a maximum of 0.385%. In contrast, none of the brands passed the non-official hardness test. Each product disintegrated in seven to twelve minutes, meeting the USP standards. Drug release rates in 45 min ranged from 78.9 to 92.6%, and drug content results were within the USP guidelines (96.55-102.76%). The current study demonstrated that all seven brands of metformin hydrochloride 500 mg tablets adhered to the quality control parameters specified in the pharmacopeia, except for the hardness test across all brands.

P-29 Metformin poisoning without lactic acidosis: Case report

Abstract Introduction Metformin is the most widely used oral antidiabetic, which belongs to the biguanide pharmacological group. Metformin-associated lactic acidosis (MALA) is a rare event with an incidence of approximately 19 cases per 100,000 patient-years. The risk of developing lactic acidosis, when taking metformin is enhanced by several factors such as: age > 65 years; concomitant diseases that have the ability to induce hypoxemia (chronic renal failure, congestive heart failure, cardiogenic shock, severe lung disease, sepsis, advanced liver disease, history of lactic acidosis); an excessive alcohol consumption; an administration of iodinated contrast agents. Clinical Case A 46-year-old man was urgently admitted with the following symptoms: drowsiness, repeated vomiting, lethargy, dizziness. The symptoms started after he administered outpatient and at own initiative 50 tablets of metformin, each tablet contains a dose of 500 mg (total dose 25g). Concomitant pathologies: diagnosed with Type 2 Diabetes for 8 years; Toxic liver cirrhosis, compensated Child-Pugh A (recently diagnosed); hypertension; CKD G3aA2 KDIGO. The patient's condition at admission was assessed as extremely serious, Glasgow scale - 11 points, mild hypertension, tachycardia, tachypnea. The paraclinical investigations revealed the presence of metabolic acidosis, but with lactate <5 mmol/l; the progressive renal dysfunction with creatinine values in the first 24 hours up to 1184 µmol/l, urea – 24.5 mmol/l; a severe hypoglycemia - 1.68 mmol/l; a moderate cytolytic syndrome; a cholestatic syndrome, an inflammatory and hepatoprive syndrome; coagulation disorders; a pancreatic dysfunction. In the context of the evident increase of urea and creatinine, the decision was made to initiate the intermittent hemodialysis, a total of 14 sessions were required during hospitalization. The particularity of this case is represented by the absence of lactic acidosis, despite metformin intoxication with altered neurological status, acute renal failure, developed due to chronic kidney disease, liver cirrhosis of toxic etiology and severe hypoglycemia. Conclusion Metformin should be administered with caution in patients with multiple comorbidities. Metformin intoxication can induce lactic acidosis with an increased risk of serious, potentially fatal adverse events. It is essential to identify metformin intoxication as early as possible, with prompt initiation of renal replacement measures and dynamic monitoring of biochemical parameters.

Comparison of Nisha-amalaki and Metformin in Overweight and Obese Patients with Type 2 Diabetes Mellitus (Madhumeha): A Randomised Controlled Trial

Introduction: Type 2 Diabetes Mellitus (T2DM) is considered a metabolic syndrome marked by an increase in blood sugar level brought on by absolute or relative insulin deficiency, insulin resistance, or both. It was predicted that 171 million individuals would develop type 2 diabetes at the turn of the century; by 2030, this figure is expected to reach 360 million. Nisha-amalaki is a commonly used medication for Type 2 Diabetes Mellitus, and its ingredients are also routinely used worldwide. There are numerous studies on Nisha-amalaki showing its antidiabetic effect, but it has not been studied in overweight and obese Type 2 diabetic patients; hence, present study is planned. Aim: To compare the efficacy of Nisha-amalaki and Metformin in overweight and obese patients with Type 2 Diabetes Mellitus. Materials and Methods: The present was a parallel-group, single-blind, randomised, standard controlled trial conducted in the Department of Kayachikitsa, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India. The trial included a 60-day treatment period and a followup period every 15 days. The study comprised a total of 60 overweight and obese patients suffering from Madhumeha, randomly divided into two equal groups. Group N (experimental group) was treated with 6 gm Nisha-amalaki Churna two times a day before meals with lukewarm water, and Group M (control group) was treated with 1 gm Tablet Metformin administered twice a day before meals in equal divided doses for 60 days. Patients were assessed for objective parameters like Fasting Blood Sugar (FBS) level, Post Meal Blood Sugar (PMBS) level, and Body Mass Index (BMI) at the start and end of the study. Statistical analysis was done by assessing through paired and unpaired t-tests and compared with the help of Z-test. Results: Madhumeha is more prevalent in the 51-60 years age group as well as in males compared to females. The mean FBS level before treatment was 151.98 mg/dL and 143.08 mg/ dL in Group M and Group N, respectively, which significantly reduced to 138.56 mg/dL and 129.39 mg/dL after treatment. The mean PMBS level before treatment was 232.45 mg/dL and 223.56 mg/dL in Group M and Group N, respectively, which reduced to 230.35 mg/dL and 209.26 mg/dL after treatment. The mean BMI before treatment was 26.49 mg/dL and 26.06 mg/dL in Group M and Group N, respectively, which reduced to 26.23 mg/dL and 25.86 mg/dL after treatment. Both the groups (standard as well as the trial group) are equally effective in reducing FBS level. During the follow-up visits, no adverse effects or side effects were observed in any patient. Conclusion: Both Nisha-amalaki Churna and Tablet Metformin are equally effective in reducing FBS level. Nisha-amalaki has a better effect compared to Metformin in reducing PMBS level. Metformin has a better effect compared to Nisha-amalaki in reducing BMI. So, it can be concluded that Nisha-amalaki Churna is as effective as Tablet Metformin in the management of overweight and obese patients suffering from Type 2 Diabetes Mellitus.

Comparative study of Nishaamalaki and metformin in obese patients of type 2 diabetes mellitus (Madhumeha): A study protocol

Background Poor synthesis of insulin by beta cells present in the pancreas combined with resistance of insulin in peripheral organs is referred to as type 2 diabetes mellitus. Insulin resistance leads to an increase in plasma fatty acids, which reduces transfer of glucose within the cells of muscles and increases breakage of lipids, resulting in an increase in hepatic glucose production. Nishamalaki (a formulation of turmeric and Indian gooseberry) is suggested in the therapy of all kinds of Madhumeha (diabetes mellitus) in Ayurveda classics. Turmeric and Indian gooseberry are the two main ingredients. Both are considered as effective medicines in the management of Madhumeha individually as well as in combined form. Aim To compare the efficacy of Nishaamalaki and metformin in obese patients of type2 diabetes mellitus. Methods The study will include 60 obese type 2 diabetes mellitus patients who were distributed into two distinct categories, each with 30 patients. Nishamalaki Churna 3gm two times a day before food with warm water for 60 days in Group N (Experimental Group) and 500 mg metformin tablets twice daily before meals for 60 days in Group M (Control Group). Every 15th day, an assessment was made (15th, 30th, 45th and 60th day). Results Objective outcomes will be assessed. Conclusion: From this study protocol, it can be depicted that the trial formulation of turmeric and Indian gooseberry (Nisha-amalaki) is as effective in obese patients suffering from type- 2 diabetes mellitus as compared to metformin tablets.

A Comparative Clinical Study to Determine the Efficacy of Bhudhatrayadi Yoga and Metformin in the Management of Madhumeha w.s.r. to Type II Diabetes Mellitus

Prameha is a chronic disease that is described in all the classics of Ayurveda. Madhumeha is categorised as a subtype of Vataja Prameha. Vata Dosha is mainly vitiated in Madhumeha. The patient passes large quantity of urine which is Kashaya (astringent), Madhura (sweet), Pandu (pale) and Ruksha (dry). Madhumeha is the final stage of all the Prameha when left untreated for long time becomes difficult to treat. In modern medicine signs and symptoms of Madhumeha resembles Type II Diabetes Mellitus. Diabetes is a metabolic disease and is characterised by increase in blood glucose levels, deficiency of insulin or resistance to insulin uptake. 40 patients were selected from the IPD and OPD of Kayachikitsa Department of R.G.G.P.G. Ayurvedic College and Hospital, Paprola, Himachal Pradesh. 20 patients were managed with Bhudhatrayadi Yoga and 20 patients were managed with Tablet Metformin. Bhudhatrayadi Yoga showed moderate improvement in subjective parameters of Madhumeha in the study.