A Randomised Controlled Trial to Evaluate the Add-on Efficacy of Nisha-Amalaki Ghan Capsule with Metformin versus D4 combination Ghan Capsule with Metformin in the Management of Aavaranjanya Madhumela (Type 2 Diabetes Mellitus)

Title

A Randomised Controlled Trial to Evaluate the Add on Efficacy of Nisha Amalaki Ghan Capsule with Metformin versus D4 Combination Ghan Capsule with Metformin in the Management of Aavaranjanya Madhumeha Type 2 Diabetes Mellitus

Introduction

Madhumeha, described in Ayurveda as a subtype of Prameha, correlates with Type 2 Diabetes Mellitus in modern medicine. It is a metabolic disorder characterised by increased blood sugar levels resulting from insulin resistance or inadequate insulin secretion. Ayurveda explains Madhumeha as a disease of Kapha and Vata imbalance, primarily caused by the obstruction of Vata by Kapha or Meda, known as Aavaran. This results in impaired metabolism and improper utilisation of glucose. The condition corresponds to Aavaranjanya Madhumeha, in which deranged Kapha and Meda obstruct the normal function of Vata leading to Prameha Lakshanas such as polyuria, polyphagia, and fatigue.

The management of Type 2 Diabetes Mellitus in modern medicine primarily relies on oral hypoglycaemic agents such as metformin. However, long-term monotherapy often fails to maintain adequate glycaemic control and may produce side effects. Ayurveda provides several herbal formulations that improve glucose metabolism, enhance insulin sensitivity, and rejuvenate the body tissues. Nisha Amalaki, a classical formulation consisting of Curcuma longa and Emblica officinalis, has proven anti-diabetic, antioxidant, and anti-inflammatory properties. The D4 combination is a polyherbal Ghan formulation comprising potent herbs known for their hypoglycaemic and rejuvenating effects. Hence, the present study aims to evaluate and compare the add-on efficacy of Nisha Amalaki Ghan capsule and D4 combination Ghan capsule when used along with metformin in patients of Aavaranjanya Madhumeha.

Objectives

The primary objective is to evaluate the add-on efficacy of Nisha Amalaki Ghan capsule and D4 combination Ghan capsule with metformin in patients with Aavaranjanya Madhumeha or Type 2 Diabetes Mellitus. The secondary objectives include comparison of clinical symptom improvement, assessment of fasting and postprandial blood glucose levels, glycosylated haemoglobin, lipid profile, and overall quality of life.

Materials and Methods

This will be a randomised, controlled, parallel-group clinical trial conducted in adult patients diagnosed with Type 2 Diabetes Mellitus fulfilling the diagnostic criteria of Aavaranjanya Madhumeha. A total of 60 participants will be selected and randomly allocated into two groups with 30 participants in each group.

Group A will receive Nisha Amalaki Ghan capsule 500 mg twice daily along with metformin 500 mg twice daily. Group B will receive D4 combination Ghan capsule 500 mg twice daily along with metformin 500 mg twice daily. The total duration of the intervention will be 60 days.

The selection of patients will be based on inclusion and exclusion criteria. Inclusion criteria include diagnosed cases of Type 2 Diabetes Mellitus aged between 30 and 60 years with mild to moderate symptoms of Madhumeha. Exclusion criteria include patients with insulin-dependent diabetes mellitus, diabetic complications, or any major systemic illness.

The trial will be conducted following Good Clinical Practice guidelines with informed consent obtained from all participants. Randomisation will be done using a computer-generated random number table, and allocation will be concealed until assignment.

Clinical assessment will be carried out at baseline, after 30 days, and after 60 days of treatment. The parameters assessed will include fasting blood sugar, postprandial blood sugar, glycosylated haemoglobin, lipid profile, and subjective symptoms of Madhumeha as described in classical texts.

Assessment Criteria

The primary outcome measures will include change in fasting blood sugar, postprandial blood sugar, and glycosylated haemoglobin. The secondary outcome measures will include change in lipid profile, body weight, and subjective parameters such as excessive urination, thirst, fatigue, and dryness of mouth.

Statistical Analysis

The collected data will be expressed as mean and standard deviation. Appropriate statistical tests such as paired and unpaired t-tests will be used to compare the intra-group and inter-group differences. A p-value less than 0.05 will be considered statistically significant.

Expected Results

It is expected that both the formulations, when administered along with metformin, will show significant improvement in glycaemic control and clinical symptoms compared to metformin alone. The Nisha Amalaki Ghan capsule group may demonstrate better efficacy due to the synergistic antioxidant and metabolic enhancing properties of Curcuma longa and Emblica officinalis.

Discussion

Ayurvedic literature describes Madhumeha as a disease caused by improper lifestyle, dietary habits, and suppression of natural urges, leading to derangement of Kapha, Meda, and Vata. The concept of Aavaranjanya Madhumeha explains the pathogenesis as obstruction of Vata by Kapha and Meda, leading to impaired metabolism. Nisha Amalaki is indicated in Prameha for its Kapha Medohara and Rasayana properties. Curcuma longa possesses curcuminoids that enhance insulin sensitivity, reduce oxidative stress, and improve lipid metabolism. Emblica officinalis rejuvenates pancreatic function, reduces glycosylated haemoglobin, and improves digestion.

The D4 combination, consisting of herbs like Gymnema sylvestre, Syzygium cumini, Momordica charantia, and Tinospora cordifolia, has hypoglycaemic, antioxidant, and immunomodulatory actions. These herbs improve glucose uptake, stimulate pancreatic beta-cell regeneration, and reduce insulin resistance. Hence, both formulations are expected to be beneficial in correcting doshic imbalance and restoring normal glucose metabolism.

Ethical Considerations

The study will be conducted after obtaining ethical clearance from the Institutional Ethics Committee. Written informed consent will be obtained from all participants prior to inclusion. Confidentiality of participant data will be maintained throughout the study. Participants will have the right to withdraw from the study at any stage without penalty.

Conclusion

This randomised controlled trial aims to scientifically evaluate the add-on efficacy of Nisha Amalaki Ghan capsule and D4 combination Ghan capsule with metformin in patients of Aavaranjanya Madhumeha. The study will help to validate Ayurvedic concepts of Aavaran and Prameha in modern clinical terms and provide an integrative therapeutic approach to Type 2 Diabetes Mellitus. If successful, these herbal formulations may serve as safe, effective, and economical adjuncts to conventional anti-diabetic therapy, thereby improving overall treatment outcomes and patient quality of life.