A Clinical Observational Study on Role of Madhu As External Application In

SYNOPSIS

TITLE OF DISSERTATION

“A CLINICAL OBSERVATIONAL STUDY ON ROLE OF MADHU AS EXTERNAL APPLICATION IN

DIABETIC FOOT ULCER.”

For Degree of MS(AYU)

Rajiv Gandhi University Of Health Science

Bangalore,Karnataka

Dr.VEERESH.S.BANDEGOLMATH

I YEAR MS(AYU)

GUIDE

DR.USHARANI. S.MS(AYU)

Prof.Dept of PG studies in shalya tantra

Ayurvedic Medical College and P.G Center ,Davangere

From,

Dr.Veeresh. S.Bandegol math

I YEAR MS(AYU)

Dept of PG Studies in Shalya Tantra

Ayurvedic Medical College and PG center,Davangere-577566

To,

The Registrar,

Rajiv Gandhi University Of Health Science

Bangalore,Karnataka

Through: The Principal and Head of the Department in Shalya Tantra

Ayurvedic Medical College, Davangere

Respected Sir/Madam,

Sub: Submission of completed proforma of synopsis for registration of the dissertation.

I request you to kindly register the below mentioned subject in my name for the registration of subject for dissertation to the Rajiv Gandhi University Of Health Science Bangalore, for the partial fulfillment of MS(AYU).

Title Of Dissertation:

“A CLINICAL OBSERVATIONAL STUDY ON ROLE OF MADHU AS EXTERNAL APPLICATION IN DIABETIC FOOT ULCER.”

Here with I am enclosing the completed Proforma of synopsis for registration of the Dissertation subject.

Thanking you,

Yours faithfully

(Dr. VEERESH S.B)

Place : Davangere

Date :
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCE

BANGALORE KARNATAKA

ANNEXURE-II

Completed proforma for registration of subject for dissertation

1.Name of the candidate

and address : Dr. VEERESH S. BANDEGOLMATH

1ST YEAR MS(AYU)

#D/13, U.K.P. CAMP

BHEEMARAYANA GUDI

TQ. SHAHAPUR,

DIST. YADAGIRI – 585 287

2.Name of Institution : AYURVEDIC MEDICAL COLLEGE

& PG CENTRE

NEAR BATHI LAKE ,P.B ROAD

DAVANGERE -577566

3.Course of study : AYURVEDA DHANVANTRI

MS(AYU)IN SHALYA TANTRA

4.Date of Admission : 15.NOV.2010

5.Topic of dissertation : A CLINICAL OBSERVATION

STUDY ON ROLE OF MADHU AS

EXTERNAL APPLICATION IN

DIABETIC FOOT ULCER.

6. BRIEF RESUME OF INTENDED WORK :

6.1 NEED FOR THE STUDY:

Diabetes is rapidly emerging public health problem especially in India & other 3rd nations. The number of adults with diabetes will rise from 135million to 300million in near feature. The increase in developing world will be sharpest. The greatest increase in number will be seen in India, where the number of diabetics will rise from 19 million to 57 million 2 decades. In the total diabetic population 15 to 20 % have foot problem.

Diabetic patients are at increased risk of developing Microvascular & Macro vascular complication with neurological deficits. Among these long standing complication like diabetic foot ulcer, Affects 30% of diabetic patients that ends in disability & mortality.

Ulceration of the foot in diabetes is a common & disabling factor & frequently leads to amputation of leg because “The diabetic patient is often divorced from his feet, unable to see them because of poor eyesight & unable to feel them because of Neuropathy”.

Diabetic foot infection is a common cause for hospitalization in India, because of the following reasons:

1)Poor socio-economic conditions,

2)Socio-cultural practice such as bare foot walking,

3)Poor knowledge of foot care among diabetic patients,

4)Inadequate facilities for diabetes care.

Even though we have recent advances in antimicrobial therapy the diabetic foot infections are still considered as serious entity. In spite of using systemic & topical antibiotic agents along with glycemic control, the resistant infection is not completely eradicated.

The medicinal property of honey has been recognized since Vedic period which has recently been rediscovered by medical profession. There are now many published reports describing the effectiveness of honey in treating the infection from wounds, with no adverse effect. It has also been shown to have an antimicrobial action against a broad spectrum microbe, fungi & it is effective against even in the antibiotic resistant bacteria.

Diabetes mellitus is multi dysfunctional systemic disorder, here is an attempt to evaluate the role of Madhu as external application in Diabetic foot ulcer in controlled diabetic patients.

6.2 REVIEW OF LITERATURE

The description of Prameha & Madhumeha are explained in:

1)Charaka Nidana sthana 4th chapter, charaka chikithsa sthana 6th chapter.

2)Susrutha Nidana sthana 6th chapter 14- 18 shloka, Susruth chikithsa sathan 11th &12th chapter.

3)Astanga Hridaya nidana 10th chapter, Asthanga Hridaya chikithsa 12th chapter.

4)Madhava Nidana 33rd chapter

5)Bhaisjya Ratnavali 37th chapter.

Reference of Madhu:

1)Astanga Sangraha sutra Sthana 6th chapter.

2)Astanga Hridaya 5th chapter 51 & 52 Shloka.

3)Bhavaprakasha pratham khanda Madhuvarga, charaka sutra sthana 27th chapter 1-6th Shloka.

Reference of indication of Madhu in Prameha & Dushtavrana :

1)Ashtanga sangraha sutra 6th chapter 91 & 92 shloka.

2)Ashtanga sangraha sutra 5th chapter 51 & 52 shloka.

3)Bhavprakash prathama khanda Madhu varga 1 to 6 shloka

4)Charaka sutra 27th chapter

5)Sushruta chikitsa 12th chapter.

Previous work done:

1)Gangadhar 1998 a clinical study in the management of dushta vruna with application of tila kalka and madhu

2)D. Rajkumar 2004 clinical study in the management of diabetic gangrene with use of ayurvedic medicaments.

3)Siddhayya aradyamath 2001 , effect of durvadi grutha in madhumehaja vruna

4)Vandana 2001 nagpur, role of kanadi thaila in the vruna of madhumehi person.

5)Mahendra 2007, nagpur, management of ulcer in diabetic patient with principal mentioned in susrutha samhitha.

6)Tripati,1995, nagpur. Role of madhu on vruna A clinical study

7)Agarwal,1967 varanasi, healing of wound in a diabetes under the influence of udumbara.

6.3 Objective of the Study

1)To review the literature of Madhumeha.

2)To review the literature of Diabetic foot ulcer

3)To Evaluate the role of Madhu in diabetic foot ulcer as external application.

7. Materials and Methods:

7.1 Source of Data: The study will be carried out on the patients attending OPD and IPD of AMCH and ATMH.Special camp conducted in AMCH & ATMH , Davangere.

7.2 Methods of collection of data

Study will be carried out on the patient diagnosed with Diabetic foot ulcer in age group of 40 – 70 years irrespective of sex ,religion, economical status and occupation.
The total number of patients taken for study will be 40 excluding drop outs.

a) Inclusion criteria:

1)Patient diagnosed with Diabetic foot ulcer are selected.

2)The age group between 40-70 yrs

3)The size of ulcer within 4 x 4 cm dimensions are included.

4)Type II DM patients are going to be taken for the study.

5)The Glycemic range ie.FBS 70-140mg/dl & PPBS 120-160mg/dl.

b) Exclusion criteria

1)Patients with severe vasculopathy conditions

2)Patients with osteomyletic changes in diabetic foot ulcer.

3)Patients with gangrenous changes in diabetic foot ulcer.

4)Patients who are suffering from HIV , tuberculosis

5)Uncontrolled diabetic conditions and juvenile diabetic patients.

Study designs

A clinical observational study on a single group.

Sample size

The total number of patients taken for study will be 40, excluding drop outs.

Method of dressing by honey:

First local and systemic examination is carried out.

Ulcer is properly washed with diluted honey , then wound debridement & necrotic tissue is removed and properly cleaned.

By measuring dimensions of wound the size of gauze is selected and dipped in honey.
The honey soaked gauze is properly applied over ulcer, and wound is closed with sterile dressing .

Duration of treatment:

Dressing will be done on every alternative days for the period of 2 month.

Fallow up:

Fallow up will be done on every 10days for the period of 2 month.

Parameters of the study:
Subjective criteria:
Pain : Absent
: Present
Itching : Absent
:Present
Objective criteria:

Size of ulcer in length
(centimeter)- Grade
0 o
0- 1 1
1- 2 2
2- 3 3

3- 4 4

Size of ulcer in breadth
(centimeter)- Grade
0 o
0- 1 1
1- 2 2
2- 3 3
3- 4 4

Discharge grade
No discharge 0
The gauze is slight wet 1
After opening the bandage
The gauze is completely wet2
The bandage moist completely within
24 hrs but no need to change the dressing3
Bandage moist completely in 24 hrs &
bandage is required to be changed 4

Floor & granulation tissue:
Smooth , regular floor, with healthy granulation tissue0

Smooth regular floor slight discharge absence of slough1
Smooth irregular slight discharge less granulation2
tissue & presence of slough
Rough floor & presence of slough with moderate 3

quantity of discharge
Rough irregular floor with more slough I profuse 4
discharge which needs frequent dressing

7.3 Does the study require any investigation or intervention to the conducted on the patient or other humans or animals? If so please describe briefly-
The study will be conducted on diabetic foot ulcer patients only.

Investigations
Blood :
Hb%
Total leukocyte count
ESR
FBS,PPBS/ RBS
HbA1c
Urine: Albumin
Sugar
Microscopic
X-ray of wound part (if necessary)

Assessment of response:

Reduction in the signs & symptoms of the diabetic foot ulcer will be observed before, during and after the treatment.

Subjective criteria like pain and itching and,the objective criteria like size, discharge, swelling around the ulcers, floor and granulation tissue will be observed before, during and after the treatment.

7.4 Has ethical clearance been obtained for your institution in case of 7.3?

Yes,obtained.

8. List of references:

1)A concise text book of surgery by somen das, published by dr.S.Das, fourth edition,

2)Bailey and love’s, short practise of surgery edited by normal S williams, christopher J.K.Bulstrode and P. Ronal o’connell, 25th edition, published in great britian in 1932,

3)A manual on clinical surgery by soman das, published by dr. S. Das, 6th edition,

4)Maharshi sushrutha’s Sushrutha Samhitha with the Nibandha samgraha commentary of Sri Dalhanacharya edited by vaidya Yadavji Trikamji Acharya,

5)Current surgical diagnosis and treatment edited by Gerad M.Doherty and lawrence W. Way, 12th edition,

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCE

BANGALORE KARNATAKA