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

Introduction

Poor pancreatic beta-cell insulin production accompanied by peripheral insulin resistance is referred to as type 2 diabetes mellitus.¹ Insulin resistance causes an increase in fatty acids in the plasma, resulting in reduced glucose transport into muscle cells and increased fat breakdown, which leads to an increase in hepatic glucose production. For type 2 diabetes mellitus to develop, insulin resistance and pancreatic-cell failure must both occur at the same time. Insulin resistance affects everyone who is overweight or obese, but diabetes only develops in those who don’t have enough insulin production to meet their level of insulin resistance.

The prevalence of obesity has increased recently, highlighting the issue’s importance on a global scale. In the United States, almost two thirds of adults are thought to be overweight or obese. In many parts of the world, identical trends may be found.² Numerous physical, psychological, and social problems have been linked to obesity, the most significant of which is type 2 diabetes. 171 million individuals were predicted to have type 2 diabetes mellitus after the completion of this era, and by 2030, this figure is projected to reach 360 million.³ The drug metformin is now routinely used to treat diabetes mellitus. With lifestyle changes, it is now regarded as the first line of treatment for type 2 diabetes mellitus because of its outstanding safety standards, effectiveness, tolerability, and high hypoglycaemia.⁴ Excitingly, epidemiological, and preclinical studies have recently shown that metformin has positive effects in addition to its effects on Glycaemic indices. It has been demonstrated to lower body weight, reduce cancer incidence and death, and extend longevity.⁴ Metformin has been a popular study topic for disorders related to obesity and ageing as a result of these effects.

Nishaamalaki is suggested in the management of obese patients suffering from diabetes mellitus in Ayurveda classics.⁵ Turmeric and Indian gooseberry are the two main ingredients. Both are individually as well as in combined form are considered as effective medicines in the management of Madhumeha (diabetes mellitus). In experimental animal models, its rhizomes were shown to exhibit anti-diabetic characteristics. Curcumin, the key component, was shown to have anti-diabetic properties, according to researchers.⁶ In one animal study, it is also found to be a weight reducing agent.⁷

Indian gooseberry contains Ellagic acid which exhibits blood sugar lowering effects by stimulating insulin production and decreasing glucose intolerance in diabetic rats. Immunohistochemistry of the pancreas revealed that in diabetic rats, Indian gooseberry increased Beta cell size as well as its count. Additionally, it decreased the glucose intolerance of diabetic rats and raised the generation of insulin stimulated by blood glucose from isolated islets.⁸ Some of the main compounds in the fruits of Emblica officinalis (such as gallotanin, corilagin, and ellagic acid) have blood glucose lowering qualities due to their characteristics of free radical scavenging, according to studies. Hyperglycaemia, heart problems, diabetic nephropathy, neuropathy, cataractogenesis, and other conditions have all been linked to it.⁹

Amalaki is rich in vitamin C. It has been shown that taking extra vitamin C helps diabetics with sorbitol build-up in their red blood cells. Vitamin C also lessens capillary fragility, which increases the risk of complications from diabetes.¹⁰ Additionally, previous research indicates that prolonged vitamin C treatment has advantageous effects on lipid and glucose metabolism in T2DM patients.¹¹

Type 2 diabetes mellitus and obesity are progressive and rapidly spreading metabolic diseases. Both have strong correlation. In modern medicine, it is studied that metformin has antidiabetic as well as anti-obesity effect. There are numerous studies on Nisha-amalaki showing its antidiabetic effect, but it is not studied in obese type 2 diabetic patients hence this study is planned.

Methods

Results

The methods worked to lower blood sugar levels (fasting and post-meal) in the trial group. Implementing suitable dietary regimen and proper exercise during treatment decreased the likelihood of return of symptoms compared to taking regular metformin tablets for the patient.

Discussion

This study will compare the therapeutic efficacy of Nishamalaki Churna with honey and metformin tablets in individuals with type 2 diabetes mellitus who are obese. Nishamalaki is mentioned as the effective management of Madhumeha (Type-2 DM) in Ayurveda classics, according to ayurvedic literature. Haridra (Curcuma longa L) is a preferred medicine for type 2 diabetes mellitus. Both Nishamalaki Churna with honey and metformin tablets were found to effectively lower FBS and BS-PP levels. Turmeric and Indian gooseberry are found in Nishamalaki Churna. Haridra (turmeric) in Veerya (potency) is Ushna (hot), and Tikta Rasa (bitter) is useful in Kaphaja Vikaras (disorders related to kapha biohumour). These substances contain qualities such as Ruksha (dry), Ushna (hot), Tishna (bitter), and Katu Vipaka (pungent), which aid in Samprapti Vighatana (pathogenesis) and hence aid in managing the obese patients suffering from Type-2 DM. However, in this work, we looked at the differences in both formulations and their influence on objective metrics. In obese type 2 diabetes mellitus, the total effects revealed which formulation is extremely effective.

Conclusions

It can be concluded that Nishamalaki Churna will be as effective as Tablet Metformin in treating the obese patients suffering from Type-2 Diabetes Mellitus.