DM is a chronic disease marked by elevated blood glucose levels. It affects 5-6% of the global adult population. Its prevalence is rising at alarming rates worldwide because of increased urbanization, high prevalence of obesity, sedentary lifestyle and stress, among other factors. The summary published by the “World Diabetes Congress” on 14^th Nov., 2009, “World Diabetes Day,” represents that diabetes affects 246 million people worldwide and is expected to affect some 380 million by 2025. More than 90% of all diabetes patients are of type 2 diabetes. Gujarat is the epicenter of India, accounting for close to 10 million cases alone. In Gujarat, a high dependence of milk products and oily foods coupled with genetic factors are responsible for this dubirious distribution.

The approach in treating diabetes has been to reduce the sugar intake i.e. excluding carbohydrate intake; but the real problem is the fat deposition in the cells leading to stoppage of insulin from doing its work. Insulin resistance, a primary defect in pathogenesis of type 2 diabetes, is the condition whereby the effectiveness of insulin in transporting glucose into cells is diminished. Insulin resistance is closely associated with cluster of conditions such as obesity, hypertension and hyperlipidaemia which is collectively known as Syndrome ‘X’ or Metabolic syndrome. Fat cells are more insulin resistant than muscle cells; therefore, one important cause of insulin resistance is obesity.

Though Prameha is Tridoshaja vyadhi, Acharyas have mainly emphasized on vitiation of Kapha dosha and medodhatwagnimandya. Meda has been described to be the anchor seat (important dooshya) of this disease. So the goal to prevent or control this disease cannot be achieved without modifying the diet and lifestyle. Further, for disintegrating the Samprapti, a formulation, which not only has antihyperglycemic/hypoglycemic effect, but also would work at the level of Dhatwagni to counteract Kapha Dosha and Medodhatu for correcting the fat and carbohydrate metabolism and insulin resistance is needed. The Mehamudgara vati (MMV) – a herbo mineral formulation comprises herbs [Table 1] with properties which can be helpful to break the etiopathogenesis of this disease.

In Group A, maximum patients (58.82%) had chronicity of ≤1 year whereas in Group B, maximum patients (40%) had chronicity of 5-10 years. A total of 70.21% among the 22.34% patients in Group A and 47.87% patients in Group B were obese (body mass index [BMI] > 25).

Both the groups have shown a highly significant relief in most of the chief complaints, associated complaints and brief psychiatry rating scale [Graphs ​[Graphs11–3]. On suspiciousness and on Gala talu shosha, both the groups have shown significant relief. On comparison by Chi square test, both the groups were equally effective in reliving all the chief complaints, associated complaints and brief psychiatry rating scale. The effect of MMV on srotodushti is shown in Graph 4.

Both Group A and Group B have shown a highly significant (P < 0.001) decrease in FBS by 9.24% and 15%, respectively [Table 3], and in PPBS by 17% and 15%, respectively [Table 4]. On comparison with the test of significance, both Chi square and unpaired “t” tests showed insignificant results, indicating that both the groups are equally effective in decreasing the blood sugar level.

MMV has shown a highly significant decrease in the serum cholesterol level by 10%, serum triglyceride level by 19% and serum HDL level by 7%. However, when these patients were split depending upon serum cholesterol >200 mg%, serum triglyceride >150 mg% and serum HDL <40 mg%, the results were better. The percentage decrease was highly significant by 15.13% and 20.52% in the serum cholesterol and serum triglyceride levels, respectively, and 5.08% increase in the serum HDL level. The integrative group has shown a 3% decrease in the serum cholesterol level, 7% decrease in serum triglyceride and 3% increase in serum HDL. However, when these patients were split depending upon serum cholesterol >200 mg%, serum triglyceride >150 mg% and serum HDL <40 mg%, the results were better. The percentage decrease was 9% and 20% in the serum cholesterol and serum triglyceride levels, respectively, and 14% increase in serum HDL [Tables ​[Tables55–7]. On comparison with the test of significance, by the unpaired “t” test, Group A was significantly (P < 0.05) better than Group B.

The effect of MMV on Urine sugar, Fasting serum Insulin and post prandial serum insulin is shown in the Tables ​Tables88–10 respectively.

After 3 months of administration of MMV, the fasting serum insulin level was increased in 68.75% of the patients. Among them, the serum insulin level was increased with the effect of decreased fasting blood sugar level in 31.25% of the patients and in 37.50% of the patients, although the serum insulin level was increased, FBS was not decreased (rather, it was increased) and in 31.25% of the patients, although the serum insulin level was decreased, FBS was also decreased. The post-prandial serum insulin level was however increased in 62.50% of the patients. Among them, the serum insulin level was increased with the effect of decreased post-prandial blood sugar level in 31.25% of the patients and in 18.75% of the patients, although the serum insulin level was increased, PPBS was not decreased (rather, it was increased) and in 37.5% of the patients, although the serum insulin level was decreased, PPBS was also decreased [Figure 1]. The effect of therapy on body mas index is shown in Graph 5 and the overall effect of therapy is shown in Graph 6.

Because of sedentary lifestyle and excessive intake of foods, which increases Kapha, the end product of digestion becomes abnormally sweet, which in turn causes an increase of medas (fat). This obstructs the nutrient channel of the remaining tissue, depriving them of nutrition. Therefore, only fat accumulates in large quantities in the body, making the person incapable of all activities. The channels of Vata become obstructed by the increased fat inside the abdomen; Vata then begins to act fast inside the abdomen, increasing the digestive capacity, making for voracious hunger and craving for large quantity of food,[7] which is presented as Kshudhadhikya (polyphagia). Kshudhadhikya (polyphagia) occurs due to tikshna and ushna guna of Pitta. In the pathophysiology of NIDDM, due to lack of insulin utilization, glucose consumption in muscle tissues is reduced, which is an essential requirement for energy. When muscle tissue does not get glucose and it demands for glucose, this is represented as polyphagia in patients. Due to Dipana and Pachana properties of the drugs present in MMV, like Triphala, Trikatu, Dadima,[8] Bidalavana, Kiratatikta[9] etc., it might have improved the digestive process by correcting Dhatvagnimandya, resulting in prevention of further medo vriddhi and by Vatashamaka property of Guggulu,[10] Haritaki[11] etc. it alleviates the Vata dosha responsible for atiagnisandhukshana. If Kshudhadhikya has occurred due to tikshna and ushna guna of Pitta, MMV may act by pacifying it with the help of its Sheeta veerya.

Trishnadhikya (polydypsia) and Gala talu shosha (dryness in mouth) occur due to Pitta vriddhi and udaka kshaya, which may be pacified by Tikta (astringent), Madhura (sweet) and Kashaya (astringent) rasa of the MMV that affects the condition by correcting Pitta dosha or due to the trishna nigrahana effect of Kiratatikta,[9] Dadima[8] and Devadaru.[12] Polyuria is commonly found in diabetics. Through polyuria, a lot of body fluid is excreted. Therefore, to compensate for this loss, the body demands for liquid, and this is called polydypsia. Because MMV significantly reduces polyuria, it in turn mechanically also reduces polydypsia. In same manner, it also shows an effect on Gala talu shosha (dryness in mouth).

Karapadatala Daha and Karapadatala Suptata (burning sensation and numbness in the palm and foot) are both common neurological complications of diabetes described in the Ayurvedic literature as Purvarupa of Prameha. They reflect one′s glycemic control. Therefore, when hyperglycemia is corrected with hypoglycemic activity of Amalaki,[13] Shunthi,[14] Pippali,[15] Kiratatikta,[9] Devadaru,[12] Dadima,[8] Rasanjana,[16] Bilva[17] etc. ingredients of MMV, relief was obtained in these neuropathic complications like Karapadatala daha and Karapadatala Suptata (burning sensation and numbness in palm and foot). Amalaki,[13] Haritaki,[11] Shunthi,[14] Maricha[18] and Guggulu[10] are said to be Nadibalya, and are thus beneficial in neurological symptoms.

Karapadatala Daha (burning sensation in palm and foot) is due to Pitta by provocation of Ushna quality or may be due to loss of Udaka, which might have been pacified by Sheeta quality of MMV. Karapadatala suptata (numbness in palm and foot) is due to Vata – decrease in Chala guna of Vyana vayu that might have been compensated by Sara guna of MMV.

Daurbalya (weakness), Pindikodweshtana (leg cramps) and Shrama (fatigue) conditions were found in many of diabetic patients because of less glucose uptake by muscle tissue for energy due to an insulin antagonist effect.[19] In the etiopathogenesis of Prameha, the Dhatus get vitiated and vitiated apyamsha of dhatus get converted into Sharira kleda and is excreted through urine.[20] As a result, Dhatukshaya takes place with manifestation of Daurbalya, Shrama and Pindikodveshtana. Therefore, significant results were obtained by the Rasayana effect of Triphala[21] and shunthi. But, this samprapti can be true in IDDM patients, whereas in NIDDM patients, obesity (Sthaulya) may be the cause for manifestation of these symptoms as, due to Medodhatvagnimandya, only fat accumulates in large quantities in the body making the person incapable of all activities. MMV, through its tikta-kashaya (bitter – astringent) rasa and ruksha (dry) guna does shoshana of the abaddha medas and through the Dipana and Pachana properties present in its ingredients like Triphala, Trikatu, Dadima,[8] Bidalavana, Devadaru[12] etc. may have corrected digestive process resulting in correction of medodhtvagni and reducing the baddha meda. The ingredients like Lauha bhasma,[22] Guggulu, Maricha, Devadaru etc. present in MMV have Medohara properties, which may help in reducing excessive meda and, thereby, relieving these complaints.

Atisweda (excessive sweating) is the symptom that arises due to medo mala vriddhi. The MMV due to its ruksha (dry) guna, Kashaya (astringent) rasa, Tikta (bitter) rasa has medohara property due to which it decreases meda and, ultimately, its mala, i.e. sweda. These properties directly, also, contribute to the adsorption of sweda.

Stress blocks the body from releasing insulin in people with type 2 diabetes; therefore, cutting stress is very essential for effective control of the blood sugar level. The ingredients present in the formulation MMV have different properties that may be helpful in minimizing the stress response or cutting stress. As Haritaki and Bibhitaki[23] are antistress agents and Shunthi is an antidepressant, they might have been cutting the stress directly. Rasayana effect of Lauha bhasma,[22] Haritaki,[11] Amalaki[13] and Pippali,[15] antioxidant properties of Amalaki,[13] Shunthi,[14] Maricha[18] and Dadima[8] and immunomodulatory properties of Amalaki[13] and Devadaru[12] might have helped in minimizing the stress response, and in the manner controlling the disease.

High blood sugar is the main characteristic and diagnostic feature of diabetes. The MMV decreased this elevated blood glucose level, which may be by its ingredients such as Amalaki,[13] Shunthi,[14] Pippali,[15] Kiratatikta,[9] Daruharidra (Rasanjana),[16] Dadima,[8] Bilva[17] and Devadaru,[12] which are proven hypoglycemic agents, whereas Lauha bhasma,[22] Guggulu,[10] Amalaki,[13] Devadaru,[12] Gokshura[24] and Haritaki[11] have Pramehahara properties. Oral administration of the extracts of Triphala significantly reduced the blood sugar level in normal and in alloxan diabetic rats. It may decrease the effect of inflammatory cytokine release in diabetics, which in turn might reduce the insulin resistance. Interestingly, the authors note that traditional medications used to treat diabetes also have significant antioxidant effects.[25]

When glucose and FFA increase, they cause oxidative stress-sensitive signaling pathways. Activation of these pathways, in turn, worsens both insulin action and secretion, leading to overt type 2 diabetes.[26] Furthermore, insulin-resistant patients, with and without type 2 diabetes, are at an increased risk for developing metabolic syndrome, a major cause of heart disease, hypertension and dyslipidemia.[27] Thus, treatment aimed at reducing the degree of oxidative stress signaling pathways might appear to warrant consideration for inclusion as part of the treatment program for patients with type 2 diabetes. Some of the drugs like Amalaki,[13] Shunthi,[14] Maricha[18] and Dadima[8] present in MMV are proven antioxidants and Lauha bhasma,[22] Haritaki,[11] Amalaki[13] and Pippali,[15] due to their Rasayana properties, might have reduced the degree of oxidative stress signaling pathways and, by that, preventing insulin resistance and Beta cell dysfunction and, ultimately, controlling the blood sugar level.

The contents of MMV – Lauha bhasma,[22] Guggulu,[10] Maricha[18] and Devadaru,[12] have Medohara effect, and Guggulu,[10] Haritaki,[11] Amalaki[13] and Shunthi[14] have a proven hypolipidemic effect due to which they may have decreased the high lipid level and BMI [Graph 5].

Group A has shown 3.15% decrease in S. creatinine whereas Group B has decreased S. creatinine significantly by 5.33%. Blood Urea was decreased in Group A by 2.93% whereas it was increased by 1.83%. [Tables ​[Tables1111–12]. Even during the follow-up period, they have not gone beyond the normal limit. The patients having abnormally high serum creatinine and blood urea levels were excluded from the study. Thus, decrease and increase in the physiological value of serum creatinine has no value, but not going beyond the normal limit after administration of MMV for 3 months, it certainly gives the safety profile of the drug as Lauha bhasma is the main ingredient of this formulation.

When the blood sugar level crosses the renal threshold, i.e. 180 mg/dl, then it starts its excretion through the urine to decrease the load of blood sugar. Although by MMV, the blood sugar level was found to have decreased, it could not come within the normal limit in all the patients; thus, urine sugar also was not found to be nil in all the patients. Therefore, on examination, urine sugar is found to be present in these patients also after the treatment.

An increased level of serum insulin gives the indication toward an insulin-secretagaug effect of the ingredients of the trial formulation – MMV. An increased level of serum insulin with a decreased blood sugar level gives the idea that the drug has worked through its insulin-secretagauge effect. Where the blood sugar level is decreased and serum insulin is also decreased, it shows that MMV might have decreased insulin resistance and increased peripheral utilization or increased insulin sensitivity. Where the blood sugar level is increased although the serum insulin level is also increased, the role of anti-insulin antibody can be thought of in the etiopathogenesis of the disease, which is not counteracted by this formulation.