RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE - KARNATAKA.
COMPLETED PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
“A CLINICAL STUDY OF YASHTIMADHU GHRITHA PICHU IN THE MANAGEMENT OF PARIKARTIKA w. s. r. to FISSURE-IN-ANO ’’
BY
DR. VEERESH SATTIGERI, B. A. M. S
M.S. (AYU) SCHOLAR
DEPT. OF PG STUDIES IN SHALYA TANTRA.
RON-582209
GUIDE
DR.CHETAN KARDALE M .S.(AYU)
ASST. PROFESSOR OF P G STUDIES IN SHALYA TANTRA
2012-2013
RAJIV GANDHI EDUCATION SOCIETY’S AYURVEDIC MEDICAL COLLEGE, HOSPITAL; P.G.STUDIES AND RESEARCH
CENTER, RON-5822O9
DIST:-GADAG (KARNATAKA-582114)
APPLICATION FOR APPROVAL OF PROJECT PROPOSAL
From,
DR. VEERESH SATTIGERI
First Year M. S. (Ayu.) Scholar,
Department of Post Graduate Studies in Shalya Tantra.
R.G.E.S.A.M.C.H & PG Research Centre
Ron, Dist.- Gadag
To,
The Registrar,
Rajiv Gandhi University of Health Sciences,
BANGALORE, Karnataka.
Through,
The Principal and Head of Department,
P.G. studies in Shalya Tantra.
R.G.E.S.A.M.C.H & PG Research Centre, Ron
Dist.- Gadag
Subject: Submission of Completed proforma for Registration of Synopsis of Dissertation.
Respected Sir/Madam,
I request you to kindly register the below mentioned subject against my name for the submission of the dissertation to the Rajiv Gandhi University of Health Sciences,
Bangalore, for partial fulfilment of M.S. (Ayu) in Shalya Tantra.
THE TITLE OF DISSERTATION:
“A clinical study of Yashtimadhu ghritha PICHU in the management of parikartika w.s.r. to fissure-in-ano’’
Here with I am enclosing the completed proforma for registration of subject for Dissertation.
Date: 26-4-2013 Yours faithfully,
Place: Ron Dr.Veeresh Sattigeri
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA.
ANNEXURE -- II
COMPLETED PROFORMA FOR REGISTRATION OF SUBJECT FOR
DISSERTATION
1) Name of Candidate : DR.VEERESH SATTIGERI
Address (In block letter) : 1st Year M.S. [AYU] SCHOLAR,
DEPT. OF P.G. STUDIES SHALYA TANTRA
R G E S AYURVEDIC MEDICAL COLLEGE,
HOSPITAL; POST GRADUATE STUDIES &
RESEARCH CENTRE, RON-582209
Permanent Address : DR.VEERESH SATTIGERI
S/O BASAVARAJ.SATTIGERI
PO: MALLAPUR, TA.RON
DIST. GADAG ( KARNATAKA)
2) Name of the Institution : R G E S AYURVEDIC MEDICAL COLLEGE,
HOSPITAL; POST GRADUATE STUDIES &
RESEARCH CENTRE, RON-582209
DIST:-GADAG, KARNATAKA.
3) Course of Study & Subject : AYURVEDA DHANVANTARI,
M.S. (AYURVEDA) IN SHALYA TANTRA.
4) Date of Admission of Course : 30 -10-2012
5) Title of the Topic :
“A Clinical Study of YASHTIMADHU GHRITHA PICHU in the Management of PARIKARTIKA w.s.r. to fissure-in-ano”
6. BRIEF RESUME OF THE INTENDED WORK
6.1 NEED FOR THE STUDY:
The earliest reference about ‘parikartika’ is available from Sushrutha Samhitha (1000 B.C). We get description about parikartika in all Ayurvedic Classics and later period authors of Ayurveda. The word parikartika[1] is mentioned in Bastikarma vyapath and Vamana-virechana vyapath.[2] Sushrutha specifies that for virechana vyapath it is Gudaparikartika and for vamana it is kantakshanana. Kashyapa has described its types in the purview of Garbhini chikitsa.[3]
The condition fissure-in-ano, commonly encountered in surgical practice has similar location, pathology and predominant features of parikartika like excruciating pain, constipation, stools streaked with blood etc.[4] Thus it is evident that parikartika can be correlated with fissure-in-ano mentioned in modern science.
Fissure-in-ano is very commonly encountered in current day to day practice. It comprises of 6-15% of anorectal disorders and is characterized by excruciating pain during and after defecation, bleeding per anum with spasm of anal sphincter.
Fissure-in-ano is a medico- surgical condition. Medical management is said to be conservative and surgical intervention is the ultimate choice in the chronic ulcers. Medical treatment for acute fissure is oral analgesics, stool softeners, soothing ointment and self dilatation (using anal dilators) on medical advice etc. Surgical management includes Lord’s dilatation, sphincterotomy, fissurectomy, anal advancement flap[5]
All these methods of modern science have one or another drawback. Prolonged administration of NSAIDs may suppress the symptom but causes gastric irritation. Application of soothing ointment produces sufficient relaxation of the sphincter, but causes significant headache and recurrence rate is 50% in this particular method of management.
In surgical treatment complication being haematoma, abscess formation recurrent ulcer formation and persistent mucous discharge. Most of the methods of treatment are expensive and requires long stay in the hospital. Lord’s dilatation which is associated with the risk of transient faecal incontinence, after lay opening, the patient has to bear severe excruciating pain, despite taking analgesics for 5-6 days.
To overcome all these problems and to prevent surgical intervention, the present study is planned to evolve an effective treatment by Ayurvedic approach. In Ayurvedic management snigdha, madhura, sheeta dravya sevana, application of pichu with yashtimadhu[6] ghrith[7] and many other medical lines of treatment has been explained. Hence in this study an attempt is made to evaluate the efficacy of yashtimadhu ghritha which has combined action like vrana ropana due to its madhura rasa, anulomana due to its sara guna, shoolaghna property[8-9]. .
Keeping in view of the lacunae of different modern medical treatments, there is a need for an effective, safe, economical, simple and short term therapy. Yashtimadhu ghritha pichu may be considered as one such treatment in Ayurveda[9] which can overcome the above said lacunae. Hence this study is taken up to explore the possibilities of yashtimadu ghritha pichu as an effective, economical and short term treatment for Fissure-in-ano.[10-11]
6.2 REVIEW OF LITERATURE:
The parikartika is explained under the vamana and virechana vyapada. Nidana,samprapti and lakshana of parikartika are explained in Charaka Samhita,Chikitsa sthana chapter -34th sloka- 16th page no –59 and Charaka Samhita siddhi sthana chapter-6 sloka-62 page 629 and
chapter-7 sloka-55
Chikitsa:
The chikitsa explained in the Sushruta Samhita sutrasthana chapter 5th sloka-42 page no-19.and Kashyapa Samhita- chapter no -2 sloka- 1 page no- 163 And Charaka Samhita,chikitsa sthana chapter -34th sloka- 16th page no –595.
Ghritha gunas;
· Explained in Bhava Prakash page no 470 chap no-18 sloka no 1,2,3,4
Yashtimadhu :
· Yashti madhu has been explained in Bhavapraakash- chap 6, sloka no 245
6.3 PREVIOUS WORKS DONE:
1. Sindhav vijayasinha. V – Role of yastimadhvadi Ghrita in the management of parikartika w.s.r fissure-in-ano (Dissertation). Jamnagar: Gujarat Ayurvedic University; 2001.
2. Raghavendra. B – Effect of Doorvadi taila in the management of parikartika w.s.r to fissure-in-ano (Dissertation). TMAE society’s Ayurvedic medical college, Hospet: Rajiv Gandhi University; 2005.
3. Aravind kumar – management of parikartika by Doorvadi taila pichu and Gudamarga vivardana a comparative study (Dissertation). Ayurveda Mahavidyalaya, Hubli: Rajiv Gandhi University; 2006.
4. Abhinetri Hegde- “Management of Parikartika / Fissure-in -ano with Doorva taila and Yashtimadhu taila – A Comparative Study”Govt Ayurvedic Medical College, Bengaluru: Rajiv Gandhi University;2010.
6.4 OBJECTIVES OF STUDY:
· To review the literature of parikartika in ayurvedic classics.
· To review about fissure in ano in modern literature.
· To evaluate efficacy of yashtimadhu ghritha pichu in parikartika.
7) MATERIALS AND METHODS:
7.1) SOURCE OF DATA
a) LITERARY SOURCE:
The source of parikartika is collected from the various classical texts of Ayurveda & Modern Science, updated with journals and internet.
b) CLINICAL SOURCE:
Patients suffering from parikartika as per Ayurvedic classics, will be selected from the OPD and IPD of RGES Ayurvedic Medical College and Hospital, RON
c) Drugs: The trial drug “yastimadhu” is collected from the local area and certified by the Dravya Guna department.
Preparation of Yashtimadhu ghritha
Yashtimadhu ghritha preparation as per Bhaishajya Kalpana Ayurvedic text12
7.2 METHOD OF COLLECTION OF DATA:
The patients who are presenting with the features of Parikartika which can be correlated with Fissure-in-ano in modern science, symptoms like excruciating pain in anal region during and after defecation, constipation, bleeding per anum i.e. stools streaked with blood, burning sensation in anal region, presence of longitudinal tear in the anal region and sphincter spasm shall be selected for study.
A. INCLUSION CRITERIA:
Ø Patients having classical features of Fissure-in-ano namely excruciating pain in anal region during and after defecation, bleeding per anum, constipation, burning sensation, presence of sphincter spasm and with a longitudinal ulcer in the anal region will be selected.
Ø Acute solitary fissures will be included.
Ø Patients suffering from parikartika as per Ayurvedic classics will be selected.
B. EXCLUSION CRITERIA:
Ø Patients suffering from any other ano rectal diseases.
Ø Patients suffering from systemic disorders like HTN, DM etc
Ø Patient suffering from infectious disease like HIV, tuberculosis etc
Diagnostic criteria
Signs & Symptoms
Ø Pain in anal region
Ø Constipation
Ø Bleeding per anum i.e. stools streaked with blood
Ø Burning sensation in anal region.
STUDY DESIGN:
A single blind clinical study with pre test and post test design.
SAMPLE SIZE:
40 cases of either sex and age group of 20 to 60 years suffering from Parikartika are randomly selected and submitted for clinical trial.
GROUP-A(TRIAL GROUP) / Patient treated with Yashtimadhu ghritha pichu
GROUP-B
(CONTROL GROUP) / Patient treated with Yashtimadhu ghritha pichu + Aabhayarishta (3 tsf, t i d daily ) + Gandhaka Rasayana(1 tab. t i d daily) and advised sitz bath twice daily.
DURATION OF TREATMENT: Seven days
FOLLOW UP: - Weekly once, up to 2 months.
SOURCE OF FORMULATION:
Yashtimadhu ghritha will be prepared in the Rasa Shastra & Bhaishajya kalpana Dept. of R G E S Ayurvedic Medical College, Hospital PG Studies & Research centre, Ron, according to the classical references.
ASSESSMENT OF RESULTS
· Depending upon subjective & objective parameters, assessment of response will be made based on Gradation Index mentioned below.
· Statistical analysis will be made using unpaired‘t’ test.
PARAMETERS OF STUDY:-
The improvement provided by therapy will be assessed on the basis of classical signs and symptoms. All the signs and symptoms will be assigned with a score depending upon their severity to assess the effect of the drugs objectively.
CRITERIA FOR ASSESMENT:
Assessment will be done based on the following parameter:-
GRADING FOR THE ASSESSMENT CRITERIA:-
For Subjective parameters:
Pain;
· No pain - 0
· Mild -1
· Moderate -2
· Severe -3
Constipation:
· No constipation - 0
· Mild -1
· Moderate -2
· Severe -3
Bleeding:
· No -0
· Mild -1
· Moderate -2
· Severe -3
Burning sensation:
· No -0
· Mild -1
· Moderate -2
· Severe -3
b. Objective parameters:
· Ulcer healing
· Sphincter spasm.
· Proctitis
· Ulcer healing
Size of the ulcer is measured in mm and filled in the digits.
· Sphincter spasm
Symptoms / Normal / SpasmodicGrading / 0 / 1
Proctitis:
Proctitis / Absent / PresentGrading / 0 / 1
7.3) Does the study require any investigations or interventions to be conducted on Patients or other humans or animals? If so please describe:
Yes
Study will be a human observational study. No animal experimentation will be conducted.
INVESTIGATIONS:
· HB
· TC
· DC,ESR
· HIV, HBsAg
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
YES (Copy Enclosed)
LIST OF REFERENCES:-
1. Monier Williams. Sanskrit English Dictionary .Chaukhambha Sanskrit Series. 1sted. Varanasi: pp.1333
2. Sushruta. Sushruta Samhita -Text with English translation by P V Sharma. 1st ed.
Varanasi: Chaukhambha vishwabharati; 2005. Vol II, pp. 695.
3. Caraka. Caraka Samhita_Text with English translation by Prof. P V Sharma. 1st ed.
Varanasi: Chaukhamba orientalia 2005. Vol II, pp. 879.
4. Sushruta. Sushruta Samhita_ with the commentaries, Nibhandha Samgraha
Commentary of Dhalhanacharya edited by Vaiya Yadavji Trikamji Acharya
and Narayana Ram Acharya Kavyatirtha. 7th ed. Varanasi: Chaukhambh Srabharati; 2002. pp. 824.
5. S Das. A concise text book of Surgery. 4th ed. Calcutta: S Das; 2006 pp. 1344.
- Sushruta. Susruta Samhita _ Text, English Translation, Notes, Appendices and Index Translated by Prof. K.R.Srikantha Murthy.2nd ed. Varanasi: Chaukhambh Orientalia; 2004. Vol. I, pp. 6569
- Bhavamishra.Bhavaprakash of Bhavamishra _Text, English Translation, Notes, Appendices and Index, Translated by Prof.K.R.Srinkantha Murthy.Varanasi:. page no 470 chap no-18 sloka no 1,2,3,
- Bhavamishra.Bhavaprakash of Bhavamishra _Text, English Translation, Notes, Appendices and Index, Translated by Prof.K.R.SrinkanthaMurthy.Varanasi: Chowkamabha Krishnadas Academy; 2004, Vol I pp738
- kashyapa samhita- text with English translation and commentary by p v tewari chapter no -2 sloka- 1 page no- 163 And
10. sushruta sushruta samhita sutrastana vaidya jadavji trikamji acharya and the rest by narayana ram achary kavyatrirtha chapter 5th sloka-42 page no-19.and
11. kashyapa samhita- text with English translation and commentary by p v tewari chapter no -2 sloka- 1 page no- 163
charaka Charaka samhita, pandit rajosharadatta shastri hindi translation chokamba publication chikista sthana chapter -34th sloka- 16th page no –595
9) Signature of the student :
( Dr. Veeresh sattigeri)
10) Remark of the guide : To reduce the recurrence rate of fissure-in-ano the
present placebo is taken for study so it can be consider
for the research work. Best of luck.
11) Name of Guide & Designation : Dr. CHETAN KARDILE M S (AYU)
Reader and PG Guide.
Department of PG studies in Shalya Tantra,
RGES Ayurvedic Medical College, Hospital
PG Studies and Research Centre, Ron
11.2) Signature of Guide :
11.3) Co-Guide : Dr. KUMAR KANTHIMATH M S (AYU)
Lecturer
Dept. of P.G. Studies in Shalya Tantra
RGES Ayurvedic Medical College, Hospital;
P.G. Studies and Research Centre, Ron
11.4) Co-Guide Signature :
11.5) Head of the Department : Dr. M.R. Subba raju M.D.(Ayu.)
Professor, H.O.D. and P.G. Guide
Department of PG studies in Shalya Tantra,
RGES Ayurvedic Medical College, Hospital;
P.G. Studies and Research Centre,
Ron-582209 Dist. Gadag, Karnataka
11.6) Signature of the HOD :
12.1) Remarks of the chairman
And principal :
The above synopsis is scrutinized by the Post Graduate Studies and Research Centre Committee of Rajiv Gandhi Education Society’s Ayurvedic Medical College, Ron and submitted for registration as subject of dissertation at R.G.U.H.S. Bangalore.
12.2) Signature :
Dr. I.B. Kotturshetti M.D. (AYU.)
Principal / C.M.O.