INTRODUCTION

Diabetes mellitus is a disease that affects body’s ability to produce or use the hormone insulin. Chronic metabolic disorder and fast-growing global problem with huge health and economic consequences. Characterized by prolonged elevated blood sugar levels which further expose a person to cardio-vascular disease, kidney failure, leg amputation, vision loss and nerve damage. Leading ailment due to sedentary lifestyle, lack of physical activity, faulty dietary habits, stress and obesity. Diabetes is classified as Type 1 and Type 2 diabetes. 

v  Type 1 diabetes - autoimmune destruction of beta cells and absolute insulin deficiency.

v  Type 2 diabetes is due to insulin resistance and defect in insulin secretion.

Type 1 diabetes cannot be prevented but Type 2 diabetes can be prevented or controlled by exercising regularly, eating healthily, avoiding smoking, and controlling blood pressure and lipids. Stress has a significant impact on metabolic function. Type 2 diabetes may be initiated by psychological and physical stress. The central and peripheral nervous systems are both involved in the neuroendocrine framework that underlies the underlying processes. The release of catecholamines and a rise in serum glucocorticoid concentrations caused by psychological stress enhance the requirement for insulin and insulin resistance. Experiencing persistent hyperglycemia in people with diabetes may be influenced by stress. Blood sugar levels may rise due to hormones being released in response to stress¹. WHO recommendations on physical activity-

v  Children and youth aged 5–17 years - at least 60 minutes of moderate- to vigorous-intensity physical activity daily.

v  Adults aged 18–64 years - at least 150 minutes of moderate-intensity aerobic physical activity (for example brisk walking, jogging, gardening) spread throughout the week, or at least 75 minutes of vigorous-intensity aerobic physical activity throughout the week, or an equivalent combination of moderate and vigorous intensity activity”².

In Ayurveda diabetes mellitus can be correlated with Madhumeha. It is Tridoshaj in origin with predominance of Vata with involvement of Kapha and Pitta. Acharaya Charak has mentioned that Kapha Dosha enhancing factors etc. are the major causative factor (Nidana) of Madhumeha. Acharaya Sushruta has mentioned Sahaj and Apathya Nimattaja varieties of Madhumeha. Acharaya Vagbhatt mentioned Nidana of Prameha are food drinks and activities which produce increase of Medas (fat), Mutra (urine) and Kapha.

All these factors described in different texts of Ayurveda implies that life style plays important role in progression of Madhumeha”³.

In case of Prameha Chikitsa walking without foot wear for 1229.59 kms is indicated⁴. Prameha is Santarpanajanya Vyadhi, thus Apatarpana became the line of treatment. For Sthoola Pramehi walking without foot wear for a distance of 800-900 miles is indicated.

According to Ayurveda Shabada Sangraha, Chankramana meaning is walking in English.

 LITERATURE REVIEW

v  The burden of diabetes is high and increasing globally, and in developing economies like India, mainly fueled by the increasing prevalence of overweight/obesity and unhealthy lifestyles. The estimates in 2019 showed that 77 million individuals had diabetes in India, which is expected to rise to over 134 million by 2045. Approximately 57 percent of these individuals remain undiagnosed⁵. 

v  More than 450 work on the disease has been carried out all over India at various institutes of Ayurveda are registered at AYUSH DHARA PORTAL till date.

v  As per the knowledge of scholar no clinical work has been carried out on Nisha Aamlaki Churna and Brahmi Churna along with Chankraman in management of Madhumeha (Type 2 Diabetes).

v  According to a much recent report by the National NCD Monitoring Survey (NNMS), the diabetes prevalence in India stood at 9.3 percent in 2018. Similar estimates have been given by IDF, where diabetes prevalence was estimated at 9.6 percent in 2021 and projected to increase to 10.4 percent by 2030⁶.

v  New National estimates for diabetes and other NCD’s: Our study estimates that in 2021, in India there are 101 million people with diabetes and 136 million people with prediabetes, 315 million people had high blood pressure, 254 million had generalized obesity, and 351 million had abdominal obesity⁷.(9 Jun 2023)

JUSTIFICATION OF RESEARCH TOPIC

A large population is affected by the condition but no complete cure is possible in modern as well as other health systems. Even in Ayurveda the condition is described Yapya.

• Very high number of diabetic populations in India and other parts of world.
• No work has been found reported towards evaluating efficacy of Nisha Aamlaki Churna and Brahmi Churna along with Chankraman
• No specific stress related intervention is given in treatment of Madhumeha (Type 2 Diabetes) in present time.

 The personnel and public health cost of diabetes are high. It has been estimated that 12 percent of the global health expenditure is spent on treating diabetes and its related complications (US dollar 673 billion), estimates the International Diabetes Federation⁸.

In Ayurveda Acharya Charak considered Madhumeha (diabetes) under Astamahagad i.e one of major disease in eight main diseases. In Chakradutt, Acharya Chakrapani told for patient of diabetes walk a hundred Yojans or more on foot and consume Amlaki only. According to Bhavprakash Nighantu Brahmi act as Pramehahara Dravya.

“Swarya Smritiprada Kusthpandumeha Astra Kasa Jita”

According to Ashtang Hridayam, Nisha Amlaki is used for Madhumeha treatment.

RESEARCH OBJECTIVE

Primary objective-

v  To compare the clinical efficacy of Nisha Aamlaki Churna and Brahmi Churna along with Chankraman in the management of Madhumeha (type 2 diabetes).

Secondary objective-

v  To assess the role of stress in Madhumeha (type 2 diabetes) according to Ayurvedic point of view.

v  To evaluate the efficacy of Nisha Aamlaki Churna and Brahmi Churna along with Chankraman in the prevention of complication of Madhumeha (type 2 diabetes).

Hypothesis

Null Hypothesis:

Nisha Aamlaki Churna and Brahmi Churna along with Chankraman is not effective in the management Madhumeha (Type 2 Diabetes).

Alternative Hypothesis:

Nisha Aamlaki Churna and Brahmi Churna along with Chankraman is effective in the management Madhumeha (Type 2 Diabetes).

RESEARCH METHODOLOGY

STUDY DESIGN:

v  Interventional open randomized comparative clinical study.

v  Total 200 patients will be enrolled in study for 10 weeks (100 patients in each group).

v  Grouping of patients: Patients fulfilling the inclusion criteria will be selected and randomly divided into two groups – Group A and Group B.

v  The patients complaining of Pipasa (Polydipsia), Kara-Pada Daha Supti, Nidradhikya, Alasya, Swed-aanga gandha, Asya madhurya, Malam kaye, Netra-jihva-shravana-updeh, Vishra sharirgandha, Shithila angata, Shita priyatwam, Shwasa, Snigdha gatrata,

Picchhila gatrata, Dantadinaam maladhytwa, Gurugatrata, Nocturia, Polyphagia etc. and fulfilling the criteria of inclusion and giving their consent to participate in the clinical trial will be selected irrespective of their sex, religion, occupation caste etc. from OPD and IPD of BKNGAC and Hospital, Narnaul, Haryana will be selected on the basis of computer-generated randomization method.

PATHYA:

Use of old rice and wheat, yava, Patola, Lashuna, Shigru, Triphala, Guduchi leaves, Kapittha, Jambu, Haridra, bitter gourd and fenugreek.

APATHYA:

Avoid with holding of urges, smoking, sedentary lifestyle, day sleep, consumption of curd, meat of Aanupa Desh, food prepared with new cereals and lentils as well as flours, excess sweet and sour and salty substances

Group A Posology

Group B Posology

DIAGNOSTIC CRITERIA

1.     The diagnostic assessment criteria will be done based on signs and symptoms of Madhumeha like Prabhutamutrata (Polyuria), Avilamutrata (Turbid urine), Kshudadhikyata (Polyphasia), Pipasadhikyata (Polydipsia), Pindikodwestanam (Leg/calf muscles cramps), Kara-Padadaha (Burning sensation in palm and soles), Kara-pada suptata (Numbness in palm and foot), Netra-Jihwa-Shravana Upadeha (Coating in eyes, tongue, ears), Alasya (Lethargy), Atisweda (Excessive sweating), Dourgandhyata (Bad smell), Aruchi (loss of appetite) and Nidradhikyata (Excessive sleep).

2.     According to WHO (2006) recommendations for the diagnostic criteria for diabetes:

Fasting Blood Plasma glucose Greater than 7.0mmol/l (126mg/dl) OR

Post Prandial Blood Plasma glucose Greater than 11.1mmol/l(200mg/dl).

INCLUSION CRITERIA:

• Patients of both male and female sexes from age group 20-60 years.
• Signs and symptoms of Madhumeha.
• Fasting Blood Plasma glucose.   Greater than 7.0 mmol/l (126mg/dl)   OR Post Prandial Blood Plasma glucose. Greater than 11.1 mmol/l (200mg/dl).
• BMI Greater than 23 Kg/m² to 30 Kg/m².

EXCLUSION CRITERIA:

• Patients of Diabetes mellitus receiving Insulin or taking allopathic medicine.
• Patients having chronic complications of Diabetes mellitus.
• Micro vascular Retinopathy, Neuropathy and Nephropathy.
• Macro vascular Coronary artery disease, Peripheral vascular disease and Cerebro-vascular disease.
• Other chronic debilitating disease like STD etc.
• Pregnant and lactating women.
• Tuberculosis and HIV.
• Patients with Prameha Pidika (carbuncle, furuncles, abscess)

CRITERIA OF WITHDRAWL:

• The participants will be allowed to withdraw from the clinical trial if there is any major ailment. Subject not responding to treatment or developing any serious adverse drug reaction of therapy will be withdrawal from the study.

 REPORTING OF ADR:

·       In case of any adverse effect noted by the patient or by the researcher will be dully reported to the concerned authorities as per law.

CONSENT PROCEDURE:

Written informed consent/Assent from patients will be taken prior to the initiation of clinical study in the recruited patients with suitable provisions for withdrawal.

FOLLOW UP: Follow up study will be carried out for one month after completion of the treatment. Pathya- apathya and chankramana will be continued during the follow up period, Medicine (if required) will be given.