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KARNATAKA
SYNOPSIS BY
Dr PARVATHY GOPAN
FOR THE DEGREE OF AYURVEDA DHANWANTARI
DEPARTMENT OF POST GRADUATE STUDIES IN SHALYATANTRA
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL,
BENGALURU, KARNATAKA-560082
2019-2020
1
FROM
TO
THE REGISTRAR
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BENGALURU, KARNATAKA
THROUGH
THE PRINCIPAL
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL, BENGALURU,
KARNATAKA-560082
Respected sir,
I request you to kindly register the below mentioned subject against my name for submission of
dissertation to Rajiv Gandhi University of Health Sciences, Bengaluru for partial fulfillment of M.S.(Ayu)
in Shalyatantra.
Here with I am enclosing the complete proforma for registration of subject for dissertation.
Thanking you,
Yours faithfully
Place: Bengaluru (Dr Parvathy Gopan)
Date:
2
ANNEXURE II
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6. BRIEF RESUME OF THE INTENDED WORK
6.1. NEED FOR THE STUDY:
In the present era about 30- 40% of the population are suffering from anorectal disorders.1 Among them
fissure-in-ano is one of the commonest having prevalence about 17.91%. 2The major predisposing factor being
change in lifestyle and food habits. Fissure-in-ano is an ulcer in the longitudinal axis of lower anal canal,
commonly occurs in midline posteriorly, but can also be occur in midline anteriorly. 95% of anal fissure in men
are posterior and 5% are anterior. 80% of anal fissures in females are posterior and 10% anterior. It is more
common in females.3
“Parikarthika”- which literally means “Karthanavat Shoola” has been explained as a stand-alone symptom in
Virechana Vyapat having Vata Pitta predominance along with other symptoms like Gudadaha and Anilasanga.
This has close similarity with “fissure-in-ano”. In this context Picchabasthi with Yasthimadhu, Krishna-Tila,
Honey and Ghee, Anuvasana Basti, Pichu, Parisheka, Lepa etc. are mentioned as management.4
Numerous studies are done in the management of fissure-in-ano as Shodhana and Ropana, here an attempt
to study the effect of Nirvapana upakrama in the management of same is taken. This upakrama is used for the
treatment of Vrana accompanied with Daha, Paka, Jwara and having Pitta Kopa and Raktena Abhibhuta. Here
Acharya mention to give Seetha Guna Dravyas macerated in Ksheera added with Ghee to be applied- as a
Lepa.7
Since fissure is having the similar symptoms this treatment can be adopted for the management of the same.
In the context of Shashti Upakrama Acharya Dalhana commented on Seethala Dravya as Durvadi, which includes
Durva, Nalamoola, Madhuka, Chandana etc. As Durva is mentioned first and having properties like Kashaya
Rasa, Seetha Virya, Kapha-Pittahara, Raktapitta Samaka and Daha Samana, it is taken here.8
4
The current study “A randomised controlled clinical study to evaluate the role of Nirvapana Upakrama with
Durva ointment in the management of Pittaja Dushta Vrana with special reference to fissure-in-ano” would be
an attempt to re-introduce and validate Nirvapana Upakrama one among Shashti Upakrama in an ointment form,
which enables easy and better storage, preservation and mode of application.
• The review of the literature includes screening of Ayurvedic classics, modern literatures, journals and
internet source to collect sufficient data for the study.
• When it is caused due to Virechana called as Gudaparikarthika which is associated with Adhah
Parisravanam.9
• Acharya Kashyapa mentioned treatment for three types of Parikarthika in Garbhini based on Dosha
in Kashyapa Samhitha Khilasthana i.e. Vataja, Pittaja and kaphja.10
• Fissure-in-ano is mainly of two types-acute and chronic. Its symptoms include chronic constipation,
sharp agonising pain during defecation, passage of bright streaks of blood along with stool. If acute
fissure-in-ano is not treated properly, will gradually developed into a deep undermined ulcer. 3
• Definition, incidence, etiology, pathology, clinical features, examination and treatment of fisssure-
in- ano explained in modern texts will be reviewed in detail.
• Malahara the root from the word Malaham or Marham. It is mainly originated from Unani System
of medicine. The word Malahara is adapted from Yogaratnakara meaning “it removes Mala”
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(residue from Vrana, Twak Vikara etc.) which is used as external application, similar to ointments in
modern. The common base used for Malahara (ointments) is Siktha Taila (beewax and Taila). 12
• Topical diltiazem gel has properties like reducing pain, inducing healing and also has effect in
sphincter relaxation.13
DRUG REVIEW
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Durva : -
a) Botanical name: - Cynodon dactylon (Linn.) Pers.
b) Family: - Poaceae
c) English: - Conch Grass
d) Part used: - Whole plant, root.
e) Properties
Guna: - Laghu
Virya: - Seetha
Vipaka: - Madhura
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Ksheera : -
English name: - Milk
Synonyms: - Payas, Ksheera
Properties
Rasa: - Madhura
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Virya: - Seetha
Vipaka: - Madhura
Karma: - Rakthapittahara
Vatapittagna
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Ghritam : -
Rasa: - Madhura
Virya: - Seetha
Vipaka: - Madhura
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Madhuchishta : -
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Karma: - Vrana Ropana
Doshaghnata: - Vataghna
Uncontrolled single armed clinical study in the management of fissure-in-ano by Durvadi Kera Taila by
V Sreedevi, Amrita School of Ayurveda, Vallikavu, Clappana, Kollam, Kerala. The study was done on 30
diagnosed cases of acute fissure- in-ano. On the basis of assessment criteria and overall result of treatment
Durvadi Kerathaila showed better result in reducing burning sensation, pain and also reduction in the size of
Vrana.18
NULL HYPOTHESIS: -
H :- There is no difference in the efficacy in the group receiving Durva ointment in fissure -in-ano than the
0
ALTERNATE HYPOTHESIS: -
H :- The efficacy of Durva ointment in fissure-in-ano is greater than the group receiving
1
diltiazem gel 2%
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6.4. AIM AND OBJECTIVES OF THE STUDY
AIM: -
To evaluate the role of Nirvapana Upakrama with Durva ointment in the management of
Pittaja Dushtavrana w.s.r to fissure-in-ano.
OBJECTIVES: -
• To evaluate the role of Nirvapana Upakrama with Durva ointment in the management of fissure-
in- ano
• To re-evaluate the role of diltiazem 2% gel in the management of fissure-in-Ano.
• To compare the role of Durva ointment and diltiazem 2% gel in the management of fissure- in-ano.
7. METHODOLOGY:
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7.2. METHOD OF COLLECTION OF DATA
STUDY DESIGN:
Study is a randomised open label controlled clinical trial in which thirty subjects are divided
into two groups of fifteen each.
GROUPING:
A number of thirty subjects suffering from Parikarthika fulfilling the inclusion criteria will be
selected by simple randomization technique. They are divided into two groups of fifteen
each. Each group will be given sitz bath followed by Triphala Choorna (dose 5-10g) at bed time
as constipation is the main factor for fissure-in-ano.
STUDY DURATION: -
SAMPLE TECHNIQUE:
SAMPLE SIZE:
Thirty subjects
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STATISTICAL ANALYSIS:
• The collected data will be presented in the form of Mean ± SD, SEM or Range whichever is
applicable.
• For parametric values paired t test within the group and unpaired t test within the group.
• For nonparametric values Wilcoxon signed rank test within the group and Mann Whitney U test
between the group
• p value ≤ 0.05 will be considered statistically significant.
• IBM SPSS Software version 20 will be used for the analysis. 21
(a)DIAGNOSTIC CRITERIA:
Subjects with classical symptoms of Parikarthika will be selected for study such as Guda Daha, Karthanavat
Peeda, Anilasanga and those having characteristics of Pittaja Dushta Vrana.
(b)INCLUSION CRITERIA:
• Clinically diagnosed cases of Parikarthika (Chronic Fissure-in-Ano will be taken for the study.)
• Patient irrespective of sex, religion, occupation and economic status.
• Patients between 21- 60 years of age irrespective of both sexes.
• Patients of Parikarthika with Diabetes and Hypertension which are under control, are also
included in study.
• Fissure-in-ano secondary to ulcerative colitis, tuberculosis, syphilis, crohn’s disease, other systemic
diseases pertaining to colon will be excluded from the study.
• Previously diagnosed cases of Ca – rectum, Ca – colon and fistula-in-ano.
d) ASSESSMENT CRITERIA:
Following subjective and objective parameters will be considered in the study.
1)Subjective parameters: -
• Gudagata Karthanavat Peeda (cutting and burning type of pain.)
• Itching
• Bleeding
• Constipation
• Burning sensation
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Pain assessment VAS Scale
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Itching
Grade 0 - Absent (no itching)
Grade 1 - Mild (Occasional itching)
Grade 2 - Moderate (Frequent itching)
Grade 3 - Severe (Continuous itching)
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Burning sensation
Grade 0 - No burning sensation
Grade 1 - Mild burning sensation
Grade 2 - Moderate burning sensation
Grade 3 - Severe Burning sensation.
1
Bleeding
Grade 0 - No bleeding
Grade 1 - Bleeding per anum.
1
Constipation
Grade 0 - Easy evacuation / Normal consistency
Grade 1 - Hard stools passed once daily
Grade 2 - Hard stools passed once in 2-3 days
Grade 3 - Very hard stools passed once in 3-4 days
2)Objective parameters: -
1
(1) Length of ulcer
After gently parting the gluteal region, the fissure will be visualized and the length of
ulcer is measured with a cotton swab by keeping it over the ulcer. This is later measured in
millimetre.
1
(2) Sphincteric spasm (by per rectal digital examination.)
Grade 0 - Normal
Grade 1 - Spastic
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(e)WITHDRAWAL CRITERIA
If general condition is worsening, treatment will be stopped and withdrawn from the study and will be treated
accordingly.
• Yes, study will be conducted on human subjects who fulfils the inclusion criteria.
• A separate case proforma will be prepared with details of history, signs and symptoms of fissure-in-
ano as mentioned in classics and allied sciences.
• Lab investigations will be done according to necessity and the findings will be documented.
• Researcher will ensure that subjects of the study are in compliance with medicine/ treatment of this
study protocol.
INTERVENTION:
GROUP A GROUP B
FOLLOW UP st th st th
Fourteen days (21 and 28 Fourteen days (21 and 28
day-to observe any day-to observe any
recurrence) recurrence)
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7.4. HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION?
YES
8. LIST OF REFERENCES
2. Ranjit Chaudary, Chirag Shanthi Dausage. Prevalence of Anal Fissure in patients with Anorectal Disorders: A
single – centre experience. Journal of Clinical and Diagnostic Research, 2019 Feb; Vol-13(2): PCO5-PCO7.
th
3. Das.S. A Concise Textbook of Surgery, 10 edition. Kolkata: Dr. S. Das .13; 2018. P.1083-86.
4. Susruta, Susrutasamhita, edited by Vaidya Jadavaji Trikamji Aacharya and Narayan Ram Acharya
‘Kavyatirtha’. Chikitsasthana.Ch.34,Ver.16. Reprint, 2015 edition,Varanasi:Choukhambha Sanskrit Sansthan,
Kashi Sanshrit series 316;2015.p.523-24.
5. Susruta, Susrutasamhita, edited by Vaidya Jadavaji Trikamji Aacharya and Narayan Ram Acharya
‘Kavyatirtha’. Soothrasthana.Ch.22,Ver.7. Reprint,2015edition,Varanasi:Choukhambha Sanskrit Sansthan,
Kashi Sanshrit series 316;2015.p.108.
6. Susruta, Susrutasamhita, edited by Vaidya Jadavaji Trikamji Aacharya and Narayan Ram Acharya
‘Kavyatirtha’. Chikitsasthana.Ch.1,Ver.8. Reprint, 2015 edition,Varanasi:Choukhambha Sanskrit Sansthan,
Kashi Sanshrit series 316;2015.p.397.
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7. Susruta, Susrutasamhita, edited by Vaidya Jadavaji Trikamji Aacharya and Narayan Ram Acharya
‘Kavyatirtha’. Chikitsasthana.Ch.1,Ver.49-50. Reprint, 2015 edition Varanasi:Choukhambha Sanskrit Sansthan,
Kashi Sanshrit series 316;2015.p.401.
8. Susruta, Susrutasamhitha,edited by Vaidya Jadavaji Trikamji Aacharya and Narayan Ram Acharya
‘Kavyatirtha’. Soothrasthan.Ch.37,Ver.4. Reprint, 2015 edition,Varanasi:Choukhambha Sanskrit Sansthan,
Kashi Sanshrit series 316;2015.p.160.
9. Susruta, Susrutasamhitha of Susruta,edited by Vaidya Jadavaji Trikamji Aacharya and Narayan Ram
Acharya ‘Kavyatirtha’. Chikitsasthana.Ch.34,Ver.21. Reprint, 2015 edition,Varanasi:Choukhambha Sanskrit
Sansthan, Kashi Sanskrit series 316;2015.p.524.
11. Agnivesa, Charaka Samhitha of Acharya Charaka, Drdabala krit, edited by Vaidya Jadavji
Trikamji Acharya, Siddhi Sthana. Ch.7. Ver.54-56. 1st edition, Varanasi: Chaukamba
Sanskrit Sansthan;1990.p.712.
13. Knight JS, Birks M, Farouk R. Topical diltiazem ointment in the treatment of chronic anal
fissure [Internet]. Br J Surg. 2001[cited 2020 Feb 24];88(4):553-56. doi:10. 1046/j.1365
-2168.2001.01736.x.Available from: https://www.ncbi.nlm.nih.gov/pubmed/11298624
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14. Sharma PV. Dravyaguna-Vijnana, Vol 2. Reprint,2008 editon.Varanasi: Chowkhamba
Krishnadas Academy;2008.p.1036-37.
17. Manish Kumar Rangrej Divya, K Malathi, S Vikram. Role of Mahishi Navaneeta and
Madhuchishta as a base for healing fissures of the feet w.s.r to Malahara Kalpana.
J Ayurveda Integr Med Sci [Internet]. 2019 Nov [2020 Feb 25];4(5): 244- 48. Available
from:http://www.jaims.in/index.php/jaims/article/view/863
18. V Sreedevi, Uncontrolled single armed clinical study in the management of fissure-in-ano by
Durvadi Kera Taila [Dissertation]. Amrita School of Ayurveda, Kollam: Amrita Viswa
Vidyapeetham, Coimbatore;2013-14.
th
20. Shastri K, editor, (11 edition). Rasatarangini of Sadanadha Sharma,
dwithiya Taranga; Paribhasha vigyaniya: Chapter 2, Verse 34. Delhi: Mothilal
Banarasi Das, 2012;17.
21. Kothari C R. Research Methodology. 2nd ed. New Delhi: New Age International(P) Ltd., Publishers; 2004
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22. Tichkule SV, Khandare KB, Shrivastav PP. Proficiency of Khanduchakka Ghrita in the
management of Parikarthika: A case report. J Indian Sys Medicine [serial online] 2019
[cited 2020 Feb 24]; 7:47-50. Available from:
http://www.joinsysmed.com/text.asp?2019/7/1/47/265514.
11.2 SIGNATURE :
11.3 CO-GUIDE :
11.4 SIGNATURE :
11.6 SIGNATURE :
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12.1 REMARKS OF :
PRINCIPLE
12.2 SIGNATURE :
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