A comparative study of Shilajatu and Asanadi Ghana Vati in the management of Madhumeha w.s.r. to type-2 diabetes mellitus

Abstract

Introduction:

Diabetes mellitus is becoming an alarming problem for society nowadays causing impediment in normal life. Diabetes and its complications impose a major burden upon health-care facilities.

Materials and Methods:

In this study, 90 patients of Madhumeha (type-2 diabetes mellitus) were registered and randomly divided into two groups. Out of 90 registered patients, 80 patients completed the treatment. In Group A, cap. Shilajatu (500 mg twice daily) was given for 3 months and in Group B, Asanadi Ghana Vati (2 Vati twice daily) was given for 3 months.

Aim:

An attempt was made to evaluate and compare the efficacy of Shilajatu and Asanadi Ghana Vati in the management of type-2 diabetes mellitus. The efficacy of therapy was assessed on the basis of improvement in sign and symptoms of diabetes mellitus, blood sugar level, and glycosylated hemoglobin

Results:

Statistically significant improvement was observed in sign and symptoms as well as on blood sugar level in both groups after the completion of treatment.

Conclusion:

Shilajatu and Asanadi Ghana Vati seem to be effective and completely safe for the management of Madhumeha (type-2 diabetes mellitus).

Introduction

Diabetes mellitus is a syndrome characterized by disordered metabolism and hyperglycemia either due to the deficiency of insulin secretion or due to the combination of insulin resistance and inadequate insulin secretion. Type-1 diabetes is due to the destruction of pancreatic islet beta cells predominantly by an autoimmune process and these patients are prone to ketoacidosis. Type-2 diabetes is the more prevalent form and results from insulin resistance with a defect in compensatory insulin secretion. Many patients with type-2 diabetes have an insidious onset of hyperglycemia and remain asymptomatic for longer period. Hence, many individuals with type-2 diabetes mellitus have complications at the time of presentation. Diabetes is now the leading cause of blindness, neuropathy, end-stage renal disease, and nontraumatic leg amputation. In addition, morbidity and mortality due to adverse cardiac events and stroke are also very common in diabetes.

Currently, a number of antidiabetic agents such as oral hypoglycemic agents and various insulin preparations are available for the management of diabetes, but their long-term applications cause various adverse effects. Therefore, the search for effective and safer drugs to manage hyperglycemia is one of the important areas of research. In Ayurveda, many plants and plant-based medications have been advocated for the management of diabetes since time immemorial. In the present study, the classical herbomineral drug, Shilajatu (Asphaltumpunjabinum) and Asanadi Gana Dravya, has been selected for the management of Madhumeha (type-2 diabetes mellitus). In Ayurvedic classics, Shilajatu is described as Naimittika Rasayana for Prameha. Asanadi Gana has been described in Ashtanga Samgraha[1] and Ashtanga Hridaya[2] for the treatment of Shwitra, Kushtha, Kaphaja-Vikara, Krimi, Panduroga, Prameha, and Medodosha. The ingredients of Asanadi Gana are Asana (Pterocarpus marsupium Roxb.), Tinisha (Ougeinia oojeinensis Roxb.), Bhojpatra (Betulautilis D. Don.), Shwetawaha (Terminalia arjuna Roxb.), Prakirya (Holoptelea integrifolia Planch.), Khadira (Acacia catechu Wild), Kadara (Acacia suma Ham), Bhandi (Albizia lebbeck Benth.), Shimshapa (Dalbergia sissoo Roxb.), Meshashringi (Gymnema sylvestre R. Br.), the three Hima, i.e. Shweta Chandana (Santalum album Linn.), Raktachandana (Pterocarpus santalinus Linn.), and Daruharidra (Berberis aristata DC.), Tala (Borassus flabellifer Linn.), Palasha (Butea monosperma Lam.), Agaru (Aquillaria agallocha Roxb.), Shaka (Tectona grandis Linn.), Shala (Shorea robusta Gaertn.), Dhava (Anogeissus latifolia Wall.), Kramuka (Areca catechu Linn.), Indrayava (Holarrhena antidysenterica Linn.), Chagakarna (Vateria indica Linn), and Ashwakarna (Dipterocarpus alatus).

The present study was carried out to assess the efficacy of Shilajatu and Asanadi Ghana Vati in the management of Madhumeha (type-2 diabetes mellitus) and compare the effect of Shilajatu and Asanadi Ghana Vati in the management of Madhumeha.

Materials and Methods

Ninety patients with classical signs and symptoms of Madhumeha (type-2 diabetes mellitus) were selected from the OPD and IPD of Department of Kayachikitsa, IMS Banaras Hindu University. The research protocol was approved by the Institutional Ethical committee (No. Dean/2012-13/125).

A proforma including classical signs and symptoms of diabetes mellitus and Srotodusti Lakshana was made for assessing all the patients. The patients were properly interrogated and examined on the basis of proforma, and laboratory investigations were carried out for diagnosis.

Inclusion criteria

1. Fasting plasma glucose ≥126 mg/dL up to 250 mg/dl

2. 2-h plasma glucose ≥200 mg/dl and up to 350 mg/dl during an oral glucose tolerance test

3. Symptoms of diabetes plus random blood glucose ≥200 mg/dl and up to 350 mg/dl

4. Patients in between 30 and 80 years

5. Patients having complication of diabetic neuropathy.

Exclusion criteria

1. Patients of type-1 diabetes mellitus cases

2. Cases with severe diabetic complications such as cardiac disease, nephropathy, and foot ulcer

3. Patients with chronic diseases such as tuberculosis, bronchial asthma, chronic renal failure, HIV, and hepatitis

4. Patient below 30 years and above 80 years

5. Patients on corticosteroid therapy.

Plan of study

Ninety patients having classical signs and symptoms of Madhumeha (type-2 diabetes mellitus) were selected for the study on the basis of inclusion and exclusion criteria and investigations done. Out of 90 registered patients, 80 patients could complete the study and 10 patients discontinued the treatment. 80 patients of the study were randomly divided into two groups:

• Group A: 40 cases of type-2 diabetes mellitus were advised to take cap. Shilajatu, 1BD (each cap. 500 mg) for 3 months (divided into three follow-ups, each of 1 month interval)

• Group B: 40 cases of type-2 diabetes mellitus were advised to take Asanadi Ghana Vati, 2 BD (each Vati 500 mg) for 3 months (divided into three follow-ups, each of 1 month interval).

Investigation

Following investigations were carried out to assess the efficacy of trial drugs (cap. Shilajatu and Asanadi Ghana vati) and to find any other systemic disease:

• Fasting blood sugar (FBS) and postprandial blood sugar (PPBS)

• Glycosylated hemoglobin % (HbA_1c)

• Lipid profile, blood urea, and serum creatinine.

Criteria for assessment

Assessment was done on the basis of improvement in the clinical symptoms (polyuria, polydipsia, polyphagia, weakness, burning sensation and numbness, joint pain, cramps, weight loss, loss of libido) with the help of suitable scoring method (0–3). Under the objective parameters, biochemical investigations (FBS, PPBS, glycosylated hemoglobin, lipid profile) have been done.

The data of all the patients were assessed statistically by using paired t-test in both groups. For inter-group comparison, unpaired t-test was used.

Criteria for assessment of overall improvement in symptoms

To determine overall improvement based on all the symptoms, a criteria was defined. Number of symptoms absent at 3^rd follow-up as compared to before treatment (in percentage) was used to define it as overall criteria for improvement as below:

1. Complete improvement 100%

2. Marked improvement 75% to <100%

3. Moderate improvement 50% to <75%

4. Mild improvement 1 to <50%

5. No improvement 0%.

Observations and Results

In this study, maximum cases (36.66%) were from the age group of 51–60 years, 63.33% were males, 77.78% were Hindus, 42.22% were graduates, 43.33% were servicemen, and 93.33% were married. Maximum cases (71.11%) were from middle socioeconomic group, 75.55% were from urban community, and 55.56% were belonging to mixed dietary habit. About 53.34% patients had negative family history and 46.67% were not having any addiction. Nearly, 55.56% were having Kaphapittaja Prakriti and 62.22% were having Rajasika Manas Prakriti. In the study, maximum chronicity was >1–3 years (25.55%). Among the chief complaints of Prameha, 83.75% patients had generalized weakness, 81.12% patients had burning sensation and numbness, 78.75% patients had polyuria, 76.25% patients had polydipsia, 73.75% patients had polyphagia, 51.25% patients had joint pain, 43.75% patients had loss of libido, 38.75% patients had cramps on walking, and 30.0% patients had weight loss.

In Group A, 79.62% of the patients had symptomatic relief in case of polyuria, 74.48% relief in polyphagia, 80.76% relief in polydipsia, 79.23% relief in generalized weakness, 75.79% relief in burning sensation and numbness, 83.33% relief in joint pain, 85.45% relief in cramps, 86.84% relief in weight loss, and 92.85% relief in loss of libido. The relief was statistically highly significant in all the symptoms.

Group B provided 69.03% improvement in polyuria, 70.34% in polyphagia, 77.44% in polydipsia, 75.48% in generalized weakness, 76.47% in burning sensation and numbness, 87.50% in joint pain, 94.33% in cramps, 91.89% in weight loss, and 79.31% in loss of libido [Table 1].

Table 1.

Effect of trial drugs on symptoms of diabetes mellitus

Overall effect of therapy

In Group A, 15% of the cases had complete improvement in the symptoms and 30% cases had marked improvement. Patients with moderate improvement and mild improvement were 40% and 12.5%, respectively. In Group B, 10% of the cases had complete improvement in the symptoms and 30% cases had marked improvement. Patients with moderate improvement and mild improvement were 35% and 25%, respectively [Table 2].

Table 2.

Overall effect of therapy on the symptoms of diabetes mellitus

FBS and PPBS reduced by 24.01% and 20.23%, respectively, in Group A, which was statistically highly significant (P < 0.001). In Group B, reduction in FBS and PPBS was 26.03% and 19.29%, respectively, which was also statistically highly significant (P < 0.001) [Table 3 and Figure 1]. Statistically significant reduction was found in glycosylated hemoglobin percentage in both groups.

Table 3.

Effect of trial drugs on blood sugar level in patients of diabetes

Figure 1.

Mean percentage fall in blood sugar levels after completion of treatment

Discussion

In the etiopathogenesis of Madhumeha, all the three Doshas and ten Dushyas get vitiated but Vata Dosha and Oja (essence of all the Dhatus) are the main factors. Vitiation of Vata may occur either due to Dhatukshaya or due to Avarana of Vata by the Doshas (Kapha, Pitta, Meda, and Mamsa).[3] Hence, in its management, such drugs are to be selected which can maintain the normal state of Agni and removes the Avarana of Vata along with Rasayana property.

Shilajatu is having Tikta, Katu, and Kashaya Rasa, Katu Vipaka, Ushna Virya, Rechaka, Shoshana, and Chedana properties.[4] It has Rasayana, Vrishya, and Pramehagna property also. Shilajatu acts on Agni (maintain the excellent status of Agni) and Srotas (removes the blockage of microchannels leading to better perfusion of tissue) by Katu Vipaka and Ushna Virya. It reduces quantity of Kapha, Meda, and Kleda by its properties. Moreover, the Rasayana property of Shilajatu nourishes the body, helps to keep the body tissue in healthy state, and improves the metabolism at each and every level of Dhatu. In various pharmacological studies, it has been seen that Shilajatu can prevent maturity onset diabetes mellitus[5] and is effective in controlling blood glucose level and lipid profile.[6]

In Asanadi Ghana Vati, most of the ingredients are having Kashaya and Tikta Rasa, Laghu and Ruksha Guna. All the drugs in this polyherbal compound are having Katu Vipaka and majority of the drugs possess of Kapha-Pitta Shamaka property. Asanadi Ghana Vati scrap out excessive Kapha and Meda from Srotas by Kashaya and Tikta Rasa. Laghu and Ruksha Guna absorb the excess Kapha, Meda, and Kleda and improve the consistency of tissue elements. Katu Vipaka enhances the Agni (normalizes the metabolic processes) and remove the Avarana (obstruction) of Vata. Moreover, in various pharmacological studies, it has been proved that almost all the drugs of Asanadi Gana have antidiabetic properties.[7]

Overall therapeutic effects of both test drugs (Shilajatu and Asanadi Ghana Vati) were found statistically significant in all the symptoms when compared with initial and follow up. On objective parameters, both drugs showed significant decrease in FBS, PPBS and glycosylated hemoglobin.

Conclusion

Although both groups showed significant relief in all the symptoms, Shilajatu provided overall more relief than Asanadi Ghana Vati. The reduction in FBS level was found slightly more by Asanadi Ghana Vati while the reduction in PPBS level was found slightly more by Shilajatu. Moreover, any adverse effects were not reported during the clinical trial of 3 months. Hence, the present trial drugs (Shilajatu and Asanadi Ghana Vati) seem to be effective and completely safe for the management of Madhumeha (type-2 diabetes mellitus).

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.