· Web viewSrinivas S- “Management of Madhumeha with Nisha Kathakadi kashaya – A clinical evaluation”, RGUHS, Bangalore in 2002. Anil Kumar Garidi- “A Clinical Study on the

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

KARNATAKA, BANGALORE

SYNOPSIS

BY

DR. KANCHANA. A. KANKANWADI

TITLE OF TOPIC

“A CLINICAL STUDY TO EVALUATE THE COMPARATIVE

EFFICACY OF VATSAKADI KWATHA AND MUSTADI KWATHA

IN THE MANAGEMENT OF MADHUMEHA W.S.R TO

TYPE-II DIABETES MELLITUS (NIDDM)”

2012 – 2013

SHRI J.G.C.H. SOCIETY’S AYURVEDIC MEDICAL COLLEGE,

GHATAPRABHA, BELGAUM, KARNATAKA

FROM:DR. KANCHANA. A. KANKANWADI

IST year M.D (Ayu), Dept. of Kayachikitsa

Shri J.G.C.H. Society’s Ayurvedic Medical College

Ghataprabha -591310, Belgaum, Karnataka.

TO:

THE REGISTRAR

Rajiv Gandhi University of Health Sciences

4th block, Jayanagar,

Bangalore, Karnataka.

THROUGH:THE PRINCIPAL AND H.O.D. OF KAYACHIKITSA

Shri J.G.C.H. Society’s Ayurvedic Medical College

Ghataprabha, Belgaum, Karnataka.

Sub: Submission of synopsis for registration of subject for dissertation

Respected Sir,I request you to kindly register the below mentioned subject against my name for the

submission of dissertation to the Rajiv Gandhi University of Health Sciences, Karnataka,

Bangalore for the partial fulfillment of M.D (Ayu) in Kayachikitsa.

I am enclosing completed Proforma for registration of subject for Dissertation.

TITLE OF DISSERTATION





Thanking you, yours faithfully

Place: Ghataprabha

Date: / /2013 (Dr. KANCHANA. A. KANKANWADI)

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

KARNATAKA, BANGALORE

ANNEXURE II

COMPLETED PROFORMA FOR REGISTRATION OF SUBJECT FOR

DISSERTATION

1. NAME OF THE CANDIDATE : DR.KANCHANA. A.

AND ADDRESS KANKANWADI IST year M.D (Ayu)

S-6, Sukhasagar apartment

Opp.3rd Railway gate

Tilakwadi, Belgaum

Karnataka PIN-590006

2. NAME OF THE INSTITUTE : Shri. J.G.C.H Society’s

Ayurvedic Medical College

Ghataprabha, Belgaum.

Karnataka PIN- 591310

3. COURSE OF STUDY : Ayurveda Vachaspathi

M.D (Ayurveda) KAYACHIKITSA

4. DATE OF ADMISSION : 19-11-2012

OF COURSE

5. TITLE OF THE TOPIC :





6. BRIEF RESUME OF THE INTENDED WORK:

6.1 NEED FOR THE STUDY Madhumeha is one among the Asthamaharoga1, Vataja Prameha2, 20 obstinate

urinary disorder mentioned by Charakacharya. It is familiar since Daivika Yuga where we get

detailed description about this disease. Since this disease is connected with the Urinary

system with the presence of sugar content in the urine, the comparison of Madhumeha with

Diabetes Mellitus is justifiable.

Madhumehi passes urine having quality concordant with Madhu in its color, taste,

smell and consistency. Madhumeha unlike other disorders is a disease of Bastigata vikara

where tridosha and dasha dooshya’s like rasadi & gambheera majjadi dhatu’s are involved

which highlights the severity of the disorder. 3

As per WHO, Diabetes Mellitus is a metabolic disorder of multiple etiology share the

phenotype of Hyperglycemia.4 It is the sweet disorder of antiquity & universality with bitter

mortality rate considered as today’s pandemic disease. It is 4th of 5 leading causes of death

worldwide.

The increase in the prevalence of the Diabetes Mellitus and awakening & awareness

about the disease among general population makes it a disease of masses now.5 Almost 98%

of diabetic population in India constitutes of Type-2 Diabetes Mellitus in which prevalence’s

of it in 2000’s has risen to 12% to 19% in urban areas and 4% to 9% in rural areas as shown

by the multi centric study by the ICMR.6

Besides the miraculous achievement of Modern Medical Science, humanity is passing

through a horror of disease, drug phobia and related complications associated with it,

particularly where fast and sedentary life style account for the man’s ignorance towards the

principles of health care.

In our Ayurvedic classics we will get enormous treatment modalities explained by

various acharyas in regard of Madhumeha Vyadhi despite it is considered as Mahatyaya for

treatment.7

So is the need of clinical research in getting a hold on this disease not only to achieve

a good glycemic control but also to treat the root cause.

In most of the samhita’s like Bruhatrayi’s and Laghutrayi’s we will get the reference

of many kashaya formulations among which Vatsakadi kwatha and Mustadi kwatha

are two of them. Vatsakadi Kwatha mentioned by Sharangadhara samhita8 and Mustadi

Kwatha mentioned by Bhaishajya Ratnavali9 are selected for the present study.

Vatsakadi kwatha has been selected for the present study based on the hypothesis that

the drugs like Vatsaka, Triphala, Daruharidra, Musta and Bijaka and Mustadi kwatha drugs

like Musta, Triphala, Haridra, Devadaru, Moorva, Indrayana, Lodra are having Tikta &

Kashaya rasa as the Pradhana Rasa and Mehagna property are potent enough to combat this

disease condition.

So the present study is taken up entitled “A CLINICAL STUDY TO EVALUATE

THE COMPARATIVE EFFICACY OF VATSAKADI KWATHA AND MUSTADI

KWATHA IN THE MANAGEMENT OF MADHUMEHA W.S.R TO TYPE-II DIABETES

MELLITUS (NIDDM)” in which attention must be paid for diabetic care in terms of

availability, accessibility and affordability to all persons with Diabetes mellitus.

6.2 Literary Review Description of Madhumeha Nidhana, Lakshana and Chikitsa are explained in

Bruhatrayi’s and Laghutrayi’s.

Detailed description of Type-II Diabetes Mellitus is explained in all most all the

Modern text books of Medicine like API text book of medicine, Davidson’s principles

and practice of medicine, Harrison’s principles of internal medicine, and internet also.

Description of Vatsakadi Kwatha available in Sharangadhara samhita & Mustadi

Kwatha in Bhaishajya Ratnavali.

Previous study done:1. Jain (Ms) S- Madhumeha Vyadhi par Madhumehahara Vati evam Vyaghri Kwatha ka

tulanatmaka Adhyayana, NIA, Jaipur in 1991.

2. Mahajan Nandini- Guduchi Kwatha ka Madhumeha (DM) mein

Prayogika Adhyayana, Smt. K G.M P Mumbai in 1998.

3. Srinivas S- “Management of Madhumeha with Nisha Kathakadi kashaya – A clinical

evaluation”, RGUHS, Bangalore in 2002.

4. Anil Kumar Garidi- “A Clinical Study on the effect of Asanadi Kwatha on

Madhumeha”, RGUHS, Bangalore in 2003.

5. Sreejith K- “Clinical Study of Katamkateryadi Qwatha in the management of

Madhumeha”, RGUHS, Bangalore in 2007.

6.3 Aims & Objectives To evaluate the efficacy of Vatsakadi Kwatha.

To evaluate the efficacy of Mustadi Kwatha.

To evaluate the comparative efficacy of Vatsakadi Kwatha and Mustadi Kwatha.

7.Materials & Methods

7.1 Source of data

Literary sourceThe details of literature of Madhumeha, Diabetes Mellitus will be incorporated in

great details from the Ayurvedic classics and other Ayurvedic and Modern Medicinal text

books, medical journals, internet etc.

Drug sourceThe raw drugs for Vatsakadi Kwatha and Mustadi Kwatha will be collected from

genuine GMP certified pharmacy and Kwatha will be prepared as per the guidelines given in

Ayurvedic literatures in Kwatha Kalpana.10

Sample source:Patients of either sex diagnosed to be suffering from Type-II Diabetes Mellitus

fulfilling inclusion and exclusion criteria approaching OPD and IPD of Shri J.G.C.H’s AMC,

Hospital by conducting special camps and other cases referred at our hospital will be

materials of study.

7.2 Method of collection of dataIt is a comparative single blind clinical study where 40 patients diagnosed to be

suffering from Type-II Diabetes Mellitus will be selected incidentally. It is divided into two

groups, Group A & Group B consisting of each 20 patients.

The signs & symptoms will be recorded on the Proforma specially designed for the

study.

Inclusion criteria:

Patients diagnosed to be suffering from Type-2 Diabetes Mellitus having classical

signs and Symptoms of Diabetes Mellitus like:

• Prabhoota mootrata

• Kshuda adhikya

• Pippasa adhikya

• Dourbalya

• Shareera bhara haani

• Kara pada daha

• Kara pada suptata

Diagnosed cases of Type-II Diabetes Mellitus within 5 years of onset.

Patients of either sex will be taken.

Both fresh & treated patients of age group between 30-70 years.

Patients of Diabetes Mellitus having

• Fasting Blood Sugar: ≥126mg/dl - ≤220mg/dl,

• Post Prandial Blood Sugar: ≥140mg/dl - ≤280mg/dl & raised urine sugar values.

Patients with other systemic disease which will not interfere with present treatment.

Exclusion criteria: Insulin Dependent Diabetes Mellitus (Type-1).

Patients of age group <30 and >70 years.

Any Systemic disorder other than Diabetes Mellitus which will interfere with present

treatment.

Diabetic patients associated with severe complications such as Diabetic Nephropathy,

Diabetic Retinopathy, Ischemic Heart Disease, Gestational Diabetes etc.

Diagnostic criteria: The patients will be diagnosed on the basis of classical signs and symptoms of

Type-II Diabetes Mellitus like

• Prabhoota mootrata

• Kshuda adhikya

• Pippasa adhikya

• Dourbalya


• Kara pada daha


The cases will be diagnosed on the basis of lab values of blood glucose and urine

glucose values like:

• Fasting Blood Sugar: ≥126mg/dl - ≤220mg/dl

• Post Prandial Blood Sugar: ≥140mg/dl - ≤280mg/dl

• Raised Fasting Urine Sugar

• Raised Post Prandial Urine Sugar

Assessment criteria: Assessment will be done on objective & subjective criteria before, during & after

treatment.

i. Subjective Criteria• Prabhoota mootrata

• Kshuda adhikya

• Pippasa adhikya

• Dourbalya


• Kara pada daha


ii. Objective criteria• Fasting Blood Sugar: ≥126mg/dl - ≤220mg/dl

• Post Prandial Blood Sugar: ≥140mg/dl - ≤280mg/dl

• Raised Fasting Urine Sugar

• Raised Post Prandial Urine Sugar

Data will be collected before, during & after therapy for which scores will be given

based on the severity. Later they will be assessed for the improvement with proper

statistical methods.

Interventions

Study design

Sample size: It is a comparative single blind clinical study consisting of 40 patients

of either sex diagnosed to be suffering from Type-II Diabetes Mellitus selected

incidentally.

Groups: The screened patients of Madhumeha will be taken for the study in two

groups consisting of each 20 patients.

Treatment: of Group A & Group B are tabulated as below.

Total Duration of treatment: 60 Days

Assessment of trial drug during the course of treatment will be done on

0th -

15th - 30th - 45th - 60th day of treatment.

Follow Up: will be done after 15 days and 30 days of completion of treatment.

Patients will be assessed for the improvement in signs & symptoms and lab values of

objective criteria. Assessment will be done according to scores given to the signs &

symptoms and applied with appropriate statistical methods.

Statistical analysis: Method used is student‘t’ test.

7.3 Does the study require any investigations or interventions to be done

on Patients or other humans or animals? If so please describe briefly.Present study does not require animals & the study require investigations or

interventions on patients which are mentioned below.

INVESTIGATIONS

Routine InvestigationsBlood- Hb, TC, DC

Drug Dosage Time Anupana Duration

Group A Vatsakadi Kwatha 48ml

B.DBefore food Sukoshna jala 60 Days

Group BMustadi Kwatha 48ml

B.DBefore food Sukoshna jala 60 Days

Urine–Albumin, Microscopy

Special Investigations Blood Glucose Test – FBS, PPBS

Urine Glucose Test –FUS, PPUS

7.4 Has ethical clearance been obtained from in case of 7.3? Yes, ethical clearance is obtained through the ethical committee formulated in

institution.

8. References

1. Agnivesha. Charaka Samhita, revised by Charaka and Dridhabala with the Ayurveda

Dipika commentary of Chakrapanidatta, Edited by Vaidya Jadavaji Trikamji Acharya.

Reprint ed. Varanasi: Chaukhamba prakashana; 2009. Indriya Sthana, Chapter 9,

Yasya shyavanimittiyamindriya Adhyaya; Sloka 8; p.368

2. Agnivesha. Charaka Samhita, revised by Charaka and Dridhabala with the Ayurveda-


Reprint ed. Varanasi: Chaukhamba Prakashana; 2009. Nidhana Stana, Chap 4,

Prameha Nidhana Adhyaya; Sloka 39; p.215



Reprint ed. Varanasi: Chaukhamba Prakashana; 2009. Chikitsa Sthana, Chap 6,

Prameha Chikitsa Adhyaya; Sloka 8; p.445

4. Dr. Yash Pal Munjal. API text book of medicine, 9th ed. Mumbai: The Association of

Physicians of India; 2012.Vol I, Section 9, Chap 1, Epidemiology and Basic

Considerations of Diabetes; p.321

5. S Shanmugam. Diabetes Mellitus, 1st Ed. New Delhi: Jaypee Brothers Medical

Publishers (P) Ltd; 2006. Introduction to Diabetes Mellitus; p.xii

6. Dr. Yash Pal Munjal. API text book of medicine, 9th ed. Mumbai: The Association of

Physicians of India; 2012.Vol I, Section 9, Chap 1, Epidemiology and Basic

Considerations of Diabetes; p.322



Reprint ed. Varanasi: Chaukhamba Prakashana; 2009. Chikitsa Sthana, Chap 6,

Prameha Chikitsa Adhyaya; Sloka 7; p.445

8. Sharangadhara. Sharangadhara Samhita Translated into English by Prof.K.R.Srikanta

Murthy, 4th ed. Varanasi: Chaukhamba Orientalia; 2001. Madhyama Khanda,

Chap 02, Kwatha Kalpana; Sloka 108; p. 69

9. Kaviraj Shri Govind Das Sen. Bhaishajya Ratnavali, Edited with Siddiprada Hindi

Commentary by Prof. Siddi Nandan Mishra, Reprint ed. Varanasi: Chaukhamba

Surbharati Prakashan; 2007. Chap 37, Prameha Rogadikara: Sloka 18; p. 697



Reprint ed. Varanasi: Chaukhamba Prakashana; 2009.Sutra Sthana, Chap 4,

Shadvirechanashatashritiya Adhyaya; Sloka 6; p.31

9. SIGNATURE OF THE :

CANDIDATE

10. REMARKS OF THE GUIDE :

11. NAME AND DESIGNATION

OF

11.1 GUIDE : DR. J. K. SARMA

M.D (Kayachikitsa)

Prof, Kayachikitsa Department

Shri J.G.C.H Ayurveda Medical College

Ghataprabha—591310

Tal-Gokak, Dist-Belgaum,

Karnataka State.

11.2 SIGNATURE :

11.3 CO-GUIDE : DR. SIDARAM M. GULED

M.D (Kayachikitsa)

Lecturer, Kayachikitsa Department




Karnataka State.

Vice Principal,

College of Pharmacy,

11.4 SIGNATURE :

11.5 HEAD OF THE

DEPARTMENT : DR. J. K. SARMA

M.D (Kayachikitsa)

Prof, Kayachikitsa Department




Karnataka State

11.6 SIGNATURE :

12.

12.1 REMARKS OF

THE CHAIRMAN :

AND PRINCIPAL

12.2 SIGNATURE :

Documents

· Web viewSrinivas S- “Management of Madhumeha with Nisha Kathakadi kashaya – A clinical evaluation”, RGUHS, Bangalore in 2002. Anil Kumar Garidi- “A Clinical Study on the