Introduction

In today’s fast-paced world, the increasing burden of lifestyle disorders has become a major concern for global health. The lack of awareness regarding Aahara (dietary habits) and Vihara (daily regimen) has led to a surge in metabolic diseases, among which Madhumeha (Diabetes Mellitus Type 2) holds a significant place.^[1] This condition, deeply rooted in Ayurvedic literature, has been extensively described in classical texts, emphasizing its chronic and progressive nature. Madhumeha is classified under Vataj Prameha,^[2,3] closely resembling Diabetes Mellitus in modern medical science. It falls under the category of Asadhaya/Krichha-Sadhya Vyadhi, indicating that it is difficult to cure and often persists throughout life.

Diabetes Mellitus is a chronic metabolic disorder characterized by elevated blood glucose levels due to insulin resistance or deficiency.^[4] The prevalence of diabetes has been steadily increasing worldwide, primarily due to urbanization, sedentary lifestyles, unhealthy dietary patterns, obesity, and lack of physical activity.^[5] According to the World Health Organization (WHO), approximately 422 million people globally suffer from diabetes, with a significant proportion residing in low- and middle-income countries.^[6] Alarmingly, diabetes is responsible for 1.6 million deaths annually, making it one of the leading causes of morbidity and mortality. The rising incidence of diabetes highlights the urgent need for effective management strategies that go beyond conventional pharmaceutical interventions.^[7-9]

Despite advancements in modern medical science, there is no definitive cure for Diabetes Mellitus. Conventional treatment primarily focuses on glycemic control through lifelong medication, including oral hypoglycemic agents (OHAs) and insulin therapy.^[10,11] However, prolonged use of these drugs often leads to adverse effects, including gastrointestinal disturbances, weight gain, cardiovascular complications, and renal dysfunction. This has prompted researchers and practitioners to explore alternative and holistic approaches for diabetes management, with Ayurveda emerging as a promising solution. Ayurveda, ancient Indian system of medicine, offers a comprehensive approach to managing Madhumeha by address. its root cause rather than merely controlling symptom.

Study design: Randomized Sampling, Single blind.

Study Type: Interventional Clinical Study.

Sample size: 60 (30 in each group)

Duration of study: 90 days

Follow-up: Every 15 days

Inclusion criteria

• Age between 20-70 years of either sex and any Sharirik Prakruti.
• Selected sign and symptoms based on both Ayurvedic and modern context.

Exclusion criteria

• Age group below 20 and above 70 years.
• Insulin Dependent Diabetes Mellitus (IDDM) and those who are under insulin therapy.
• Pregnant and lactating women.
• Patient with Cirrhosis of liver, Pancreatitis, HIV, Hepatitis.
• Patients with acute complications like Hyperglycemia and Hypoglycemic Coma.
• Patient with chronic Diabetic complications like Nephropathy, Neuropathy and Retinopathy.

Intervention

Group A: Treated internally with Trayushnadi Gutika (Gokshur Kwatha Bhavita)

Group B: Treated internally with Trayushnadi Gutika (Amalaki Swarasa Bhavita)

Posology

Group A: Trayushnadi Gutika (Gokshur Kwatha Bhavita) 1g Two times a day after meal with luke warm water.

Group B: Trayushnadi Gutika (Amalaki Swarasa Bhavita) 1g Two times a day after meal with luke warm water.

Table 1: Ingredients of Trayushnadi Gutika

• Moderately increased (3 - 4 meals) - 2
• Markedly increased (5 - 6 meals) - 3

4. Pipasadhikya

• Feeling of thirst 7 - 9 times/24 hours, either/or Intake of water 5 – 7 times/24 hours with quantity 1.5 – 2.0 liter/24 hours - 0
• Feeling of thirst 9 - 11 times/24 hours, either/or Intake of water 7 - 9 times/24 hours with quantity 2.0 - 2.50 liter/24 hours - 1
• Feeling of thirst 11 – 13 times/24 hours, either/or Intake of water 9 – 11 times/24 hours with quantity 2.50 -3.00 liter/24 hours - 2
• Feeling of thirst >13 times/24 hours, either/or Intake of water >11 times/24 hours with quantity >3.00 liter/24 hours - 3

5. Kara-Pada-Tala Daha

• No Suptata, Daha - 0
• Daha incontinuos - 1
• Daha continuous but bearable & not severe - 2
• Daha continuous and severe & Unbearable - 3

6. Daurbalya

• Can do routine exercise/work - 0
• Can do moderate exercise with hesitancy - 1
• Can do mild exercise only, with difficulty - 2
• Cannot do mild exercise too - 3

7. Pindikodveshtana

• No cramps - 0
• Cramps after walking more than 1 km. - 1
• Cramps after walking ½ km - 2
• Inability in walking even ½ km - 3

8. Klaibya

• Normal - 0
• Decreased frequency with normal performance - 1
• Decrease frequency with insufficiency - 2
• No sexual stimulation at all - 3

Statistical analysis

All information which was based on various parameters was gathered and statistical analysis was carried out in terms of mean (X), Standard Deviation (S.D.), Standard Error (S.E.),

In Group A, maximum 28 (93.33%) of the patients were married while 0% was unmarried, 2 (6.67%) are widow and widower. In Group B, maximum 29 (96.33%) of the patients were married while 0% was unmarried, 1 (3.34%) are widow and widower. In Group A, 6 (20%) of the patients were from lower economic class, 16 (53.34%) of the patients were from middle class and remaining 8 (26.66%) of the patients were from upper economic class.

In Group B, 3 (10%) of the patients were from lower economic class, 20 (66.67%) of the patients were from middle class and remaining 7 (23.33%) patients were from upper economic class. In Group A, 6 (20%) of the patients were rural and 24 (80%) of the patients were urban. In Group B, 11 (36.67%) of the patients were rural and 19 (63.33%) of the patients were urban.

In Group A, 2 (06.66%) patients had tobacco addiction, 22 (73.33%) were having tea/coffee addiction, 1 (03.33%) were having smoking, and 2 (06.67%) were having other addiction and 4 (13.34%) patients having no addiction. In Group B, 3 (10.00%) patients had tobacco addiction, 21 (70.00%) were having tea/coffee addiction, 0 (0%) was having smoking, and 3 (10.00%) were having other addiction and 2 (06.66%) patients having no addiction. In Group A, 11 (36.67%) patients were vegetarian and 19 (63.33%) were mixed. In Group B, 10 (33.33%) patients were vegetarian and 20 (66.67%) were mix.

In Group A, 5 (16.67%) patients were having Heena appetite, 22 (73.33%) were having Madhyama appetite and remaining 3 (10%) of the patients were having Uttama appetite. In Group B, 6 (20%) patients were having Heena appetite, 20 (66.66%) were having Madhyama appetite and remaining 4 (13.34%) of the patients were having Uttama appetite. In Group A, 15 (50.00%) patients were having regular bowel, 7 (23.33%) patients were irregular bowel and 8 (26.67%) were constipated bowel.

In Group B, 18 (60.00%) patients were having regular bowel, 5 (16.67%) patients were irregular bowel and 7 (23.33%) were having constipated bowel. In Group A, 15 (50.00%) patients were having sound sleep and 11 (36.67%) patients were having disturbed sleep, 7 (23.33%) having reduced sleep at night and 5 (16.66%) were having day-sleep.

In Group A, 3 (10.00%) patients were having sudden mode of onset and 27 (90.00%) patients were having gradual mode of onset. In Group B, 2 (06.67%) patients were having sudden mode of onset and 28 (93.33%) patients were having gradual mode of onset. In Group A, 2 (06.67%) patients were having less than 1 year’s chronicity, 22 (73.33%) patients were having 1 to 10 years and 6 (20.00%) patients were having greater than 10 years chronicity of disease. In Group B, 4 (13.33%) patients were having less than 1 year’s chronicity, 21 (70.00%) patients were having 1 to 10 years and 5 (16.67%) patients were having greater than 10 years chronicity of disease.

Signs and Symptom wise distribution

In Group A, 25 (83.33%) patients were having Prabhuta Mutrata, 19 (63.33%) patients were having Avila Mutrata, 22 (73.33%) patients were having Trishnadhikya, 23 (76.66%) patients were having Kshudhadhikya, 19 (63.33%) patients were having Kara-Pada-Tala Daha, 20 (66.66%) patients were having Pindikodwesthana and 24 (80.00%) patients were having Daurbalya.

In Group B, 22 (73.33%) patients were having Prabhuta Mutrata, 18 (60.00%) patients were having Avila Mutrata, 21 (70.00%) patients were having Trishnadhikya, 19 (63.33%) patients were having Kshudhadhikya, 23 (76.66%) patients were having Kara-Pada-Tala Daha, 21 (70.00%) patients were having Pindikodwesthana and 26 (86.66%) patients were having Daurbalya.

Associated Signs and Symptom wise distribution

In Group A, 20 (66.66%) patients were having Madhurasyata, 22 (73.33%) patients were having Tandra, 21 (70.00%) patients were having Gurugatrata and 16 (53.33%) patients were having Klaibya.

In Group B, 19 (63.33%) patients were having Madhurasyata, 23 (76.66%) patients were having Tandra, 24 (80.00%) patients were having Gurugatrata and 18 (60.00%) patients were having Klaibya.

Effect of therapy in Group-A: In this group, 27 patients of Madhumeha were included. The patients were given Trayushnadi Gutika Sample-A with dose of 1 Vati (1 gm) twice a day with Luke warm water, after meal, for the duration of 90 days.

Discussion

The drug Trayushnadi Gutika, prepared using Gokshura Bhavana in Group A and Amalaki Swarasa Bhavana in Group B, was administered to 60 patients over a period of 90 days. However, six patients discontinued the trial, leaving a total of 54 participants whose symptoms and clinical signs were statistically analyzed. Both groups - Trayushnadi Gutika Sample-A and Trayushnadi Gutika Sample-B - were thoroughly assessed, and a comparative study was conducted to evaluate the differences between the two formulations.

Discussion on demographic profile

Age group: All the patients included in this study were age group of 21 to 70 years. In both group A & B maximum patients are in the age group of 51-60 years. While in group B 33.34% patients belongs to age group of 41-50 years. It shows that maximum prevalence of Madhumeha (DM type 2) at Madhyama Avastha.

In both group A & B having 20% prevalence of Madhumeha (DM type 2) in age group of 61-70 years. Generally, it is observed that people above 40 years suffer from DM type 2, above observation support this fact.

93.33 % patients are married and 6.67 % are widow & widower of group A while 96.66 % patients are married and 3.34 % are widow & widower of group B.

Occupation: In present study shows that 6.67% patients were students, 20% were service, 10% had business, 33.33% were Housewife/Household and 30% are others in group while 3.34% patients were students, 26.66% having service, 16.66% having business, 33.34% are Housewife/Household and 20.00% are others in group B.

This figure shows that disease usually occurs in those people who having sedentary life style like Housewife/Household people, Service man or women, etc. Stress was also most important factor for precipitating of DM type 2.

Socio-economic Status: In this study maximum number of patients belongs to Middle class i.e. 53.34%, 26.66% belongs to Upper class and 20% belongs to Lower class in group A While 66.67% patients belongs to Middle class, 23.33% belongs to Upper class and 10% belongs to Lower class in group B.

Above observation shows that maximum patients belongs to Middle class but not any specific conclusion can be drawn from this observations because this study was carried out in Government Hospital and here patients coming to their socio-economic conditions.

Habitat: Present study shows that 20% of the patients were living in rural area and 80% of the patients were living in urban area in group A While 36.67% of the patients were living in rural area and 63.33% of the patients were living in urban area in group B.

Above observation shows that prevalence of DM type 2 is more in urban than in rural areas. This shows the deranged life style, altered food behavior, etc.

Nature of work: 66.67% patients were having sedentary life, 23.33% patients were having active life and 10.00% were having heavy work life in group A while 73.33% patients were having sedentary life, 20.00% patients were having active life and 06.67% were having heavy work life in group B. Above observation shows that sedentary life play important role to cause Madhumeha.

while 23.33% patients were having VP Prakriti, 33.34% patients were having VK Prakriti and 43.34% patients were having KP Prakriti in group B.

Samhanana: patients 06.67% patients were Pravara Samhanana, 90.00% were having Madhyama Samhanana and 3.34% were having Avara Samhanana in group A. while 93.33% were having Madhyama Samhanana and 06.67% were having Avara Samhana in group B.

Satva: 6.67% patients were Pravara Satva, 86.66% patients were Madhyam Satva and 6.67% were Avara Satva in group A, while 6.67% patients were Pravara Satva, 90% patients were Madhyama Satva and 3.33% were Avara Satva in group B.

Satmya: 6.66% patients were Pravara Satmya, 90% were Madhyam Satmya and 3.34% were Avara Satmya in group A, while 10% patients were Pravara Satmya, 83.33% were Madhyama Satmya and 6.67% were Avara Satmya in group B.

Rogabala: 20% patients were Heena Rogabala, 70% were Madhyama Rogabala and 10% were Uttama Rogbala in group A, while 13.33% patients were Heena Rogabala, 83.33% were Madhyama Rogabala and 03.34% were Uttama Rogabala in group B.

Rogibala: 10.00% patients were Heena Rogibala, 83.33% were Madhyama Rogibala and 06.66% were Uttama Rogibala in group A, while 16.66% patients were Heena Rogibala, 76.67% were Madhyama Rogibala and 06.67% were Uttama Rogibala in group B.

Mode of onset: 10.00% patients were having sudden mode of onset and 90.00% patients were having gradual mode of onset in group A, while that 06.67% patients were having sudden mode of onset and 93.33% patients were having gradual mode of onset in group B.

Chronicity: 06.67% patients were having less than 1 years chronicity, 73.33% % patients were having 1 to 10 years and 20.00% patients were having greater than 10 years chronicity of disease in group A, while that 13.33% patients were having less than 1 years chronicity, 70.00% % patients were having 1 to 10 years and 16.67% patients were having greater than 10 years chronicity of dise. in group B.

Treatment History: 26.67% patients were taking Allopathic treatment,

From these observations it can be concluded that Sample-A provided better relief in Prabhuta Mutrata than sample B.

Avila Mutrata: In group A 54.67% relief was observed and highly significant (P<0.001), while in group B 51.02% relief was observed and highly significant (P<0.001) .

Trishnadhikya: In group A 60.28% relief was observed in Trishnadhikya and highly significant (P<0.001), while in group B 66.05% relief was observed and highly significant (P<0.001). From these observations it can be concluded that Sample B provided better relief than sample A.

Kshudhadhikya: In group A 69.72% relief was observed and highly significant (P<0.001), while in group B 68.10% relief was observed and highly significant (P<0.001).

Kara-Pada-Tala Daha: In group A 79.16% relief was observed and highly significant (P<0.001), while in group B 81.96% relief was observed and highly significant (P<0.001). From these observations it can be concluded that Sample A & B provide good relief.

Pindikodwesthana: In group A 52.41% relief was observed and highly significant (P<0.001), while in group B 48.64% relief was observed and highly significant (P<0.001). From these observations it can be concluded that Sample A provided better relief than sample B.

Daurbalya: In group A 47.13% relief was observed and highly significant (P<0.001), while in group B 56.48% relief was observed and highly significant (P<0.001). From these observations it can be concluded that Sample B provided better relief than sample A.

Effect of Trayushnadi Gutika (sample A & B) on associated complaints

Madhurasyata: In group A 51.02% relief was observed and highly significant (P<0.001), while in group B 68.92% relief was observed and highly significant (P<0.001). From these observations it can be concluded that Sample B provided better relief in Prabhuta Mutrata than sample A.

Gurugatrata: In group A 41.92% relief was observed and highly significant (P<0.001), while in group B 38.24% relief was observed and highly significant (P<0.001) .

• Trikatu having Katu Rasa, Laghu and Tikshna Guna can improves digestion of food as well as enhance absorption of nutrients.
• In this formulation Guggulu is taken equal half. So, its effect will be also more. It promotes weight loss, manage cholesterol level and improve blood sugar level. It also works on urinary disorders.
• Gokshur having Madhura Rasa, Guru and Snigdha Guna and Sheetavirya can improve Agni, acts as Vatanulomaka, Mootrala, Kaphanissaraka, Balya, Vrishya, In other words, it acts as antioxidant, may boost libido, reduce blood sugar level, reduce blood pressure, etc.
• Amalaki Swarasa act as diuretic, laxative, stomachic, etc.

Conclusion

Trayushnadi Gutika appears to be effective due to its properties, including Katu Rasa, Ruksha Laghu Guna, Vatanulomaka, Agnideepana, Kapha-Medo Hara, Mootrala, Rasayana, and Ushna Veerya. These properties play a crucial role in the management of Prameha (Madhumeha). Trayushnadi Gutika samples A and B were prepared according to Chakradatta Pramehadhikara. The ingredients of both samples were identical, with the only difference being the Bhavana process - Sample A was prepared using Gokshura Kwatha, whereas Sample B was prepared using Amalaki Swarasa. Both formulations demonstrated significant efficacy. While both samples showed considerable relief in various signs and symptoms of Madhumeha, Sample-A exhibited slightly greater improvement compared to Sample B. However, some specific symptoms showed better improvement in Trayushnadi Gutika Sample B than in Sample A. The study found both formulations to be highly significant in terms of clinical effectiveness, with a notable percentage of relief observed.

Laboratory investigations revealed maximum improvement in blood sugar levels. Both drugs played an important role in regulating F.B.S. and P.P.B.S., along with contributing to the reduction of S. Cholesterol, thereby aiding in bringing these parameters closer to the normal range. The present study was conducted with certain limitations, restricting laboratory investigations such as HbA1c, TLC, and Lipid Profile.