A Comparative Clinical Study To Evaluate The Efficacy Of Katankateryadi Kwatha And Shuddha Shilajit In The Management Of Madhumeha W.S.R To Diabetes Mellitus(type 2)

INTRODUCTION

Diabetes Mellitus refers to a group of common metabolic disorders that share the phenotype of hyperglycemia .The major etiological factors of the disease are reduced insulin secretion , decreased glucose utilization,and increased glucose production. Polyuria(frequent urination), polydipsia (increased thirst) and polyphagia (increased hunger)are the main characteristic symptoms of this disease. It is one of the initial diseases described in Egyptian manuscripts. In Ancient Ayurvedic texts this disease is described as Madhumeha, a Vatajsub-type of the disease Prameha, characterized by passing of excessive amount of turbid urine.

The incidence of Diabetes has risen dramatically in the recent times presumably because of reduced activity levels and increasing obesity , and the aging of the population which are also the main etiological factors for this disease. According to latest WHO data an estimated 422 million people suffer from DM globally.2 The global prevalence of diabetes among adults has risen from 4.7% in 1980 to 8.5% in 2014.3 The prevalence of this disease increases with the age, however in the recent times it is seen that it has started effecting the younger age groups and even adolescents are suffering from DM. India actually has the highest number of diabetics of any one country in the entire world and is emerging as diabetic capital of the world. According to International Diabetes Federation, there were 69.1 million cases of diabetes in India in 2015.

Hyperglycemia in Diabetes mellitus result either from insulin insufficiency or insulin dysfunction. Type I diabetes (insulin dependent) is caused due to insulin insufficiency because of lack of functional beta cells. Patients suffering from this are therefore totally dependent on exogenous source of insulin while patients suffering from Type II diabetes (insulin independent) are unable to respond to endogenous insulin and can be treated with dietary changes, exercise and medication. Type II diabetes is the more common form of diabetes constituting 90% of the diabetic population.

REVIEW OF LITERATURE:

AYURVEDIC REVIEW:

The disease has been extensively described in ancient Ayurvedic texts of all times including *Brihattrayi and Laghuttrayi.Others include Yogratnakar, Vangasen, Chakradatta, Bhaishajya-Ratnavalietc.*This disease has been included in Ashtamahagadasby acharya Charaka, Sushrutaand *Vagbhatta.*6 The elaboration of Prameha includes its Nidan, Poorvaroopa, Roopa, Upshaya, Sampraptiand Chikitsa. Vitiated tridoshasaffects dhatusincluding Abaddha Meda, Rakta, Shukra, Ambu, Vasa, Lasika, Majja, Rasa, Ojasand Mansaleads to development of the disease and the main site of pathogenesis being the bastior the mootrashya(urinary bladder). Srotasinvolved are mootravahaand medovaha. The specific symptomatology of twenty types of Prameha’s has been described for diagnostic purpose. The complicated state of the disease in Ayurveda could be read under the heading prameha pidikas.

MODERN REVIEW

Almost all the text books of western (modern) medicine have mentioned Diabetes and its complications. Etiopathogenesis of the disease along with their symptoms, treatment, prognosis and management is described in detail. Evidences are available in Ayuveda and modern medical sciences which justify the correlation of Madhumehato Diabetes mellitus. Type-1A Diabetes Mellitus results from autoimmune beta cell destruction while individuals with Type-1B Diabetes Mellitus lack immunological markers indicative of an autoimmune destructive process of beta cell. Type 2 DM is a heterogeneous group of disorders characterised by variable degrees of insulin resistance, impaired insulin secretion, and increased glucose production.

TRIAL DRUGS REVIEW:

Indigenous compound formulation used for the trial is KATAN**KATERYADI KWATHA AND SHUDDHA SHILAJIT.

***1.***KATANKATERYADI KWATHA: This indigenous compound drug formulation is described in Chakraduttfor the treatment of Prameha. The contents of the formulations are as follows;

(chakardutta Prameha chikitsa 35/23)

1.DARUHARIDRA

2.MULETHI

3.CHITRAK

4.HARITAKI

5.BIBHITAKI

6.AMALAKI

2.SHUDDHA SHILAJIT**:**

The description of this drug is available in Bhaishajyaratnavalifor the treatment of Prameha. The content of the formulation is only shuddha shilajit. (Bhaishajyaratnavali Prameha Chikitsa 37/8)

Shilajit (Latin- Asphaltum punjabianum) is one of the MAHARAS (classified drug) mentioned in the classical texts (Rasgranthas).

It has many synonyms in the texts which suggest that it is obtained from the mountain tops, and is an exudate which is found in the summer season.

Sanskrit name- Shilajatu

Latin name- Asphaltum punjabianum

Synonyms – Shaileya, Shila niryas, Ashmaj, Girij, Adrij, Ashmaj, Ashmotth, Ashmlaksha, Girijatu

**DIAGNOSTIC CRITERIA:**Diagnosis will be made on the basis of symptoms given in ancient texts and modern literature. Laboratory investigations and clinical findings shall be considered for making diagnosis. WHO criteria for diagnosis of diabetics condition are as follows:

·      Fasting plasma glucose  7.0 – 8.4 mmol/L or ( 125-150mg/dl)   or

·      Two hour plasma glucose 11-13.8 mmol/L (199- 250mg/dl) during an oral glucose tolerance test.

·      Note: 1. Random is defined as without regard to time since the last meal. Fasting is defined as no caloric intake for at least 8 hrs.

·      The test should be performed using a glucose load containing the equivalent of 75g anhydrous glucose dissolved in water.

INVESTIGATIONS:

Routine Investigations:

Routine investigation will be done before treatment and after treatment

CBC

LFT

KFT

Lipid profile

Urine-routine and microscopic examination

Specific investigations:

·    FBS & PP will be done every month.

·    HbA1c (Glycosylated Hemoglobin)  (Before and after treatment)

·      RBS (at every 15th day)