A randomized comparative clinical study on the effect of rasnadi basti and madhutailika basti in the management of prameha with special reference to type 2 diabetes mellitus

Introduction : Basti, a key Ayurvedic Panchakarma therapy, involves administering medicated oils or decoctions through the rectum to balance doshas, particularly Vata. Acharya Charaka considers it "Ardha Chikitsa."

Prameha, a chronic Tridosha disorder, mainly involves Kapha imbalance, impaired metabolism, and dysfunction of Dhatus and Strotas, leading to excessive urination and systemic symptoms. Poor diet, sedentary lifestyle, and genetics contribute to its development.

Diabetes Mellitus is a metabolic disorder marked by chronic hyperglycemia due to insulin deficiency or resistance. WHO defines it as a chronic disease caused by insufficient or ineffective insulin.

Rasnadi Basti may help in managing Prameha by targeting Meda Dhatu, improving metabolism, and reducing insulin resistance. Madhutailika Basti, prepared with honey and oil, is beneficial for chronic Vata disorders and may help regulate blood glucose levels.

Need of study : Diabetes is a growing global health challenge, with cases rising from 108 million in 1980 to 537 million in 2021. It caused 6.7 million deaths in 2021, with a higher burden in low and middle-income countries. The global prevalence of type 2 diabetes is 6.1%, but in India, it is significantly higher at 11.4%. Projections estimate 643 million cases by 2030 and 784 million by 2045. India, heavily affected, had 77 million diabetics in 2019, with Gujarat alone recording 1,61,578 cases in 2015. These trends highlight the urgent need for public health interventions. Till now no such research has been conducted to evaluate the effects of Rasnadi Basti in the management of Prameha. Hence keeping this in view the present study is planned to evaluate the efficacy of Rasnadi Basti and Madhutailika Basti in the management of Prameha w.s.r. to Type 2 Diabetes.

Research question :

Is Rasnadi  Bastieffective in the  management of Prameha  with special reference to type 2 diabetes mellitus or not ?

Aims and objectives:

Aim : To study the effect of Rasnadi  Bastiand Madhutailika  Bastiin the management of Prameha  W.S.R.  to Type 2 Diabetes Mellitus.

Objectives:

1.       To study the clinical effects of Rasnadi  Bastiin the management of Prameha  with reference toType 2 Diabetes Mellitus.

2.       To study the clinical effects of Madhutailika  Bastiin the management of Prameha  with reference to Type 2 Diabetes Mellitus.

3.       To compare the clinical effects of Rasnadi Basti and Madhutailika  Bastiin the management of Prameha  with reference to Type 2 Diabetes Mellitus.

Methodology :

Materials And Methods:

1.        Sources of data :

(a)     Literary source:

All the available classical, modern literature and contemporary texts including the journals and online websites regarding the Prameha, Basti  Karma and Diabetes Mellitus type 2 will be reviewed and documented for the study.

(b)     Pharmaceutical source :

Medicine will be prepared in the GMP certified Pharmacy of Parul Institute of Ayurved.

(c)     Clinical source:

Diagnosed cases of Prameha, will be selected from OPD and IPD of Parul Ayurved Hospital, Limda, Vadodara, and Khemdas Ayurved Hospital, Ishawarpura, Vadodara, and  Parul Sevashram Hospital, Vadodara and special campaigns  fulfilling the criteria of selection and who are willing to participate in the present study will be included for the clinical study.

Method of collection of data:

a)       Sample size: 44

b)      Study design: Comparative Clinical Trial with pre and post assessment.

c)       Study Duration: 18 months

d)      Duration of treatment: 13 days

Treatment Group :

1.       Group A – Rasnadi Basti

2.       Group B – Madhutailika Basti

Diagnostic criteria : According to the American Diabetes Association (ADA)

1. Glycated hemoglobin test - 6.5 % 0r > 6.5 %

2. Fasting plasma glucose level - = 126 mg/dl or > 126 mg/dl (7.0 mmol/L)

3. Post prandial plasma glucose level - = 200 mg/dl > 200 mg/dl ( 11.1 mmol/L)

Assessment criteria :

Subjective criteria –

·         According to WHO – Scoring of Ayurveda Symptoms- GAU

1.       Prabhuta Mutrata (Polyuria)

2.       Mutr**amadhurya (Glycosuria)

3.       Pipasa-Adhikya (Increased Thirst)

4.       Kshudha-Adhikya (Increased Appetite)

5.       Swedadhikya (Perspiration)

6.       Angagandha (Bad odour)

7.       Nidradhikya (Increased Sleep)

8. Hasta-Pada-Tala Daha

9.       Kara-Pada Suptata

·         Improvement of quality of life: It will be assessed by Quality of Life Instrument for Indian Diabetes Patients-

1.       Role limitation due to physical health (Social life, work, traveling)

2.       Physical Endurance

3.       General Health

4.       Treatment Satisfaction

5.       Symptom Botherness

6.       Financial Worries

7.       Emotinal/Mental health

8.       Diet Advice Tolerance

Objective criteria –

1.       Fasting blood sugar level (FBS)

2.       Post prandial blood sugar level (PP2BS)

3.       HbA1c

Intervention:

44 Patients of Prameha  who fulfills the inclusion criteria will be randomly selected and assigned into following 2 groups each comprising of 22 patients.

Group A – Rasnadi Basti – 22 patients. Each patient will be subjected to Rasnadi basti.

Group B – Madhutailika Basti - 22 patients. Each patient will be subjected to Madhutailika basti.

Duration – 10 days as per kala basti krama.

The effect of Basti chikitsa will be assessed by following criteria-

1. Basti adana kala 2.Basti pratyagamana kala 3.Dharana kala 4. Samyaka niruha basti lakshanas 5. Samyaka anuvasan basti lakshanas