A Clinical Study On The Effect Of Asanadigana Bhavita Silajatu In Prameha With Artavadusti -A Proof Of Concept Study

INTRODUCTION

Diabetes mellitus is a lifestyle related and non-communicable disease. Due to modern urbanized lifestyle, man is not able to maintain daily healthy routine which is the reason for diabetes and various diseases. It’s a metabolic disease characterized by abnormal increase of glucose in the blood due to complete or relative deficiency of insulin and imbalance in carbohydrate, protein and fat metabolism. Factors leading to abnormal glucose level includes reduced insulin secretion, decreased glucose utilization, and increased glucose production. This disease usually presents symptoms such as polyuria, polydipsia and polyphagia. The disease is scientifically associated with the relationship of diet, lifestyle, environmental and genetic factors

The Human being knows the disease of Meha / Prameha / Madhumeha since Vedic period. The etiology, predisposing factors, pathogenesis, prognosis, complications and management have also been extensively described in Ayurvedic literature hence traditionally and from the classical texts meha/prameha/madhumeha can be equated with diabetes mellitus. Acharya Sushruta has included it in the Ashtmahagad to explain the importance of Prameha as a disease.In this disease, the quality of excreted urine is like the color and taste of honey (honey) and the urinary tendency is excessive and cloudy(Prabhuta aavil mutrata).Sedentary habits (Asyasukham), excessive sleep, curd, meat soup of domesticated animals (Gramya), meat and products of aquatic (Audka) animals and animals living in marshy land (Anupa), food made from milk, freshly harvested paddy and Addiction to foods made from them, alcoholic beverages, diets made of jaggery and sweets and all kapha-promoting factors are responsible for the cause of prameha. In Ayurveda, each Acharya has mentioned similar causes as the general diagnosis of Prameha. Twenty types of Prameha (diabetes subtypes) are available in Ayurveda and their complications have been described in details.

Meha has been treated with various ayurvedic formulations, which include herbs and herbomineral yoga(i.e.Shilajatu) From the Vedic period to the Samhita period, and after the period of Nagarjuna, herbomineral  yoga have been widely used. A careful survey of the Rasashastras and other Ayurvedic texts reveals that Shilajit is an important herbomineral medicine among the Maharas. Describing its importance, Charaka has said, "There is hardly any curable disease which cannot be reduced or cured with the help of Shilajit (Ch.Chi.1-3/65). According to Acharya Sushruta, Salasradi Gana are described as Mehhara Yoga. And in Rasa Tarangani, Shilajit (purified by Triphala Kwatha) and Salsaradi Gana are mentioned for the treatment of aggravated diabetes .This Yoga (salsaradi gana bhavita shilajatu)is  also important Because it has been described in various Ayurvedic texts like Bhaisajya Ratnavali, Ashtanga Hridayam, Ashtanga Samagra, Chakradatta  for the treatment of Meha disease .

According to World Health Organization (WHO) data from the 2021, globally, an estimated 537 million adults (20-79 years) are living with diabetes. The prevalence of diabetes is increasing rapidly, according to the International Diabetes Federation (IDF)  an estimated data was 422 million in 2014, while 240 million peoples are living with undiagnosed diabetes. This number will increase  about 643 million by 2030 and 783 million by 2045 without any intervention. In between Type 2 diabetes accounts for about 85-90% of the all cases. According to the IDF, there were 6.7 million deaths in 2021 and about 80% of diabetes deaths occurred in low- and middle-income countries. International Diabetes Federation Says an estimated 77 million Indians are diabetic (2020 data),that is constitutes 10% of the total diabetic population.

NEED OF THE STUDY:-

Diabetes mellitus is burning problem today. It occurs due to Ārtavaduṣṭi also. Today there is a need to study deeply and implement the Ayurvedic principle in the treatment of diabetes mellitus type-2 with Ārtavaduṣṭi.

Many research works have been done and many are in process for treatment of Prameha with Ārtavaduṣṭi but

Asanādigaṇa-bhāvita Śilājatu has not been taken for a trial since now and till now the significant solution of prameha with Ārtavaduṣṭi has not been found so this study is being done.

 RESEARCH QUESTION:-

Is the trial drug Asanādigaṇa-bhāvita Śilājatu effective in the management of Prameha (~Type 2 Diabetes Mellitus) with Ārtavaduṣṭi?

HYPOTHESIS:-

NULL HYPOTHESIS (H0)

There is no efficacy of Asanādigaṇa-bhāvita Śilājatu in the management of Prameha (~Type 2 Diabetes Mellitus) with Ārtavaduṣṭi.

ALTERNATE HYPOTHESIS (HA)

There is efficacy of Asanādigaṇa-bhāvita Śilājatu in the management of Prameha (~Type 2 Diabetes Mellitus) with Ārtavaduṣṭi.

 AIM & OBJECTIVES:-

AIM-

To study the effect of Asanādigaṇa-bhāvita Śilājatu in the management of Prameha (~Type 2 Diabetes Mellitus) with Ārtavaduṣṭi.

OBJECTIVES-

To evaluate the efficacy of Asanādigaṇa-bhāvita Śilājatu in the management of Prameha (~Type 2 Diabetes Mellitus) with Ārtavaduṣṭi.

MATERIAL AND METHOD :-

LITERARY MATERIALS:

Literary work will be carried out by compiling & analysing the concepts of the Prameha (~Type 2 Diabetes Mellitus) and Ārtavaduṣṭi in both Āyurveda & modern perspective.

 CLINICAL MATERIALS:-

STUDY DESIGN:

Study Type - Non Randomized Clinical Trial

Purpose - Treatment

Masking - Open label

Sample Size – 40

CRITERIA FOR DIAGNOSIS:-

Sign and symptoms of Prameha (~Type 2 Diabetes Mellitus).  Fasting plasma glucose ≥ 126 mg/dl or Post Prandial glucose level 200-400 mg/dl or HbA1c ≥ 6.5%

(According to WHO Criteria).

SELECTION OF THE PATIENT:-

30 Patients of Prameha (~Type 2 Diabetes Mellitus) with Ārtavaduṣṭi will be selected from OPD/IPD of NIA, DU Hospital, Jaipur.

INCLUSION CRITERIA:-

Female patients in the age group of above 18 years and below 50 years.

Patients with classical signs and symptoms of Prameha (~Type 2 Diabetes Mellitus) with Ārtavaduṣṭi.

Only uncomplicated cases of Prameha (~Type 2 Diabetes Mellitus).

EXCLUSION CRITERIA:-

Patients having Diabetes mellitus Type-1 [IDDM].

Menopaused females having Diabetes mellitus Type-2.

Patients having malignancies, serious illness.

WITHDRAWAL CRITERIA:-

Subject not responding to treatment or developing any serious adverse drug reaction of therapy will be withdrawn from the study.

Unwilling patients.

INVESTIGATIONS:-

CBC, ESR, TSH, FBS, PPBS, HbA1c, Urine-R&M.

TRIAL DRUGS: Asanādigaṇa-bhāvita Śilājatu (Aṣṭāṅgahṛdaya cikitsāsthāna 12/34)

Asanādigaṇa (Aṣṭāṅgahṛdaya sūtrasthāna 15/19-20)

SUBJECTIVE PARAMETERS:-

1. Prabhūtamūtratā (A. Quantity of urine B. Frequency of Urine)

2. Āvilamūtratā (Turbidity)

3. Pipāsādhikyatā (Increased Thirst)

4. Kṣudhādhikya (Increased Appetite)

5. Svedādhikya (Perspiration)

6. Aá¹…gagandha (Bad odour)

7. Nidrādhikya (Increased Sleep)

8. Hasta-pāda-tala dāha (Burning sensation in sole & palm)

9. Kara-pāda suptatā (Numbness in hands and feet)

10. Ālasya (Laziness)

11. Ārtavaduṣṭi

SUBJECTIVE CRITERIA - The changes observed in the signs and symptoms will be assessed by adopting suitable scoring pattern before and after treatment.

OBJECTIVE PARAMETERS: -

LABORATORY INVESTIGATIONS-

Before trial: CBC, ESR, TSH, FBS, PPBS, HbA1c, Urine-R&M.

After trial: CBC, FBS, PPBS, HbA1c, Urine-R&M.

 DRUG INTERVENTION: Asanādigaṇa-bhāvita Åšilājatu tablet - 500 mg in the morning and evening before food for 90 days.

OUTCOME -

PRIMARY OUTCOME MEASURES:-

Change in the subjective parameters of disease.

SECONDARY OUTCOME MEASURES:-

Change in objective parameters like CBC, FBS, PPBS, HbA1c, Urine-R&M.

 STATISTICAL ANALYSIS: Parameters will be assessed on the base of statistical tests

SUBJECTIVE PARAMETERS: Wilcoxon’s paired rank test.

OBJECTIVE PARAMETERS: Paired ‘t’ test.