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1 Impact factor: 3.958/ICV: 4.10 ISSN: Pharma Science Monitor 7(4), Oct-Dec 2016 PHARMA SCIENCE MONITOR AN INTERNATIONAL JOURNAL OF PHARMACEUTICAL SCIENCES Journal home page: A RESEARCH ARTICLE ON EFFECT OF APAMARGADI PRATISARANEEYA KSHARA IN THE MANAGEMENT OF ARDRA ARSHAS Kiran Kumar Reddy.B *1, Avnish Pathak 2, Mahesh kumar.e.s 3, Prasanna N.Rao 4, Gopi Krishna.B.J 5 1 PG scholar, Department of Shalya Tantra, SDM college of Ayurveda & Hospital, Hassan. 2 Associate Professor, Department of Shalya Tantra, SDM college of Ayurveda & Hospital, Hassan. 3 Associate Professor, Department of Shalya Tantra, SDM college of Ayurveda & Hospital, Hassan. 4 Professor and principal, SDM college of Ayurveda & hospital, Hassan. 5 Associate Professor, Department of Shalya Tantra ABSTRACT Arshas is an ailment that affects almost all economical groups of population at all ages, uncommon in paediatric group. Though Arshas has its own complications like severe haemorrhage leading to anaemia, inflammation, pain, thrombus formation, painful defecation hampering routine life, but can be managed by medication and surgical intervention. Pratisaraneeya kshara has proved its efficacy as surgical medicament in arshas with minimal invasive technique and less discomfort to patient. Kshara Karma is a one of the parasurgical procedure in Ayurveda, where it does surgical action of scraping and chemichally obliterating haemorrhoidal plexes and cures the disease with minimal intervention. In this studyapamargaditeekshna Pratisaraneeya Kshara is used in Ardra Arshas (Internal haemorrhoids). KEYWORDS: Kshara, Apamargadi, Arshas, Ardra Arshas. INTRODUCTION Ayurveda, the science of Indian system of medicine from ancestral age holds good in understanding the concept of diseases and treating them with sucsess is divided into eight branches. Shalyatantra is considered as superior, due to its additional benefit of surgical intervention in many untreatable conditions. Haemorrhoids have synonyms like Gudaja, Guda keela, Guda praroha, Gudavalipraroha,Anamakam, Payuroga, Durnama, Mamsankura, and Mamsapraroha1. These synonyms explains its pathophysiology, the severity of the disease and its adverse effects on lifestyle of a person. Kshara chikitsa has been in practice since 500 BC. As per Sushruta, the kshara is prepared from 22 plants such as Apamarga(Achyranthus aspera),palasha(butea monospermum), Kadali(Mimosa paradisiaca),snuhi( Euphorbia nerifolia),aragwada(cassia gigantica), Tila(Sesamum indicum), etc 2 The wide descriptions of Arsha including its treatment

2 Impact factor: 3.958/ICV: 4.10 ISSN: are available in the classics. But to emphasize its graveness, Arsha is enumerated under the heading of Ashtomahagada and occurs inguda Pradesha, the seat of sadyapranahara Marma which requires delicate management 3. Modern system of treatment has adopted a variety of methods like sclerotherapy 4 (injection of sclerosent agent in submucosa of piles), rubber band ligation, infra-red coagulation (IRC), cryosurgery (using N 2 O gas), haemorrhoidectomy, etc., according to the nature and degree of pile mass, but these procedures have their own merits and demerits with limitations 5. Charakacharya has given more importance on the conservative treatment and prescribed suitable dietary regimen with drugs to the patients for curing of Arsha by Deepana and pachana karmas to improve the agni(enhancement of digestive capacity) in the body 6. Further, he has also advised kshara treatment for different types of Arsha. However, every system of medicine has given its own way of treatment for treating the Arsha. Sushruta has basically mentioned four types of treatment modalities in Arshas, i.e., Bheshaja, ksharakarma, Agni karma and Shastra karma for Arsha. He has given more emphasis on ksharakarmamodality. This kshara is prepared in three potency forms ie: mrudu, madhyama and teekshna form. It is also utilised in different forms ie: paneeya kshara as internal medication in some diseases, pratisaraneeya kshara for local application on localised lesions. Chakradatta added detailed literature on Ksharasutra, which was briefly told by Sushruta Acharya 8. Among them Ksharasutra method which has been proved very effective in the treatment of fistula in ano, pratisaraneeya ksharain different types of piles, fissure-in-ano is also being practiced widely. This effectiveness can be attributed only due to the potency of the particular content, i.e., kshara. In Gada Nigraha Apamargadi kshara was explained for pratisarana on Arshas. In this regard, it is reviewed that several different preparations of plants have been tried locally to treat hemorrhoids by many investigators as well as the agencies. But kshara in piles and Ksharasutra therapy in fistula-in-ano are found to be superior over the others 9. Acharya Shodala in his treatisegadanigraha described kshara preparation with combination of drugs. Among them Apamargadi kshara is one, in which kshara is prepared using equal volumetric proportion of ashes ofapamarga, Palasha, Kadali. It is described in bhagandaradikara with main indication in Arshas 10. Previous studies on kshara prepared with single drugs had few drawbacks in postoperative period, like severe burning sensation, pain, more discharge, delayed healing of lesion in single group and comparative group studies. So it s time to explore new combinations which were

3 Impact factor: 3.958/ICV: 4.10 ISSN: explained by Acharyas so as to evaluate its efficacy in operative and postoperative period to achieve the result in patient as stated by Acharyas with minimal postoperative complications. In this study I selected Apamargadi kshara from treatise GadaNigraha to evaluate its combined effect of three drugs on arshasand its postoperative results. MATERIALS AND METHODS The patients were selected from the outpatientdepartment (OPD) and inpatientdepartment (IPD), fromdepartment of Shalyatantra, SDM college of Ayurveda and hospital, Hassan, Karnataka. Total 30 patients are selected with signs and symptoms of bleeding internal haemorrhoids (Ardra-Arshas) are included in this study. Study planning: Necessary laboratory investigations are done to fulfil the inclusion and exclusion criteria of the study. 30 patients are considered for this study who fulfils the inclusion criteria as a single group study. The patients selected will be underwent ksharakarma on haemorrhoids in a single sitting and followed once in a week for four weeks with total duration of 28 days study. Criteria of assessment: a) Bleeding 0- No bleeding 1- Bleeding only during defecation 2- bleeding during and after defecation which stops within 30 minutes of defecation 3- Bleeding irrespective of defecation. b) Pain 0- No pain 1- Pain during defecation 2- Pain during and after defecation but reduces within 30 minutes 3- Pain during rest also / irrespective of defecation c) Defecation / constipation 0- No constipation / easy evacuation of stools 1- Mild / hard stools once in a day 2- Moderate / hard stools once in 2 days 3- Severe / hard stools once in morethan 2 days d) Colour of pilemass 0- Bluish red in colour 1- Pinkish colour

4 Impact factor: 3.958/ICV: 4.10 ISSN: Slightly black in colour 3- Reddish black in colour (pakwajambuphala varna) e) Tonicity of anal sphincter 0- Normal tonicity 1- Hypertonicity 2- Severe hypertonicity (admitting index finger with difficulty or not even admitting finger during rectal examination). f) Size of pilemas 0- Complete reduction in size of pilemass 1- Moderate reduction in size of pilemass 2- Slight reduction in size of pilemass 3- Noreduction in size of pilemass Method of application of Apamargadikshara: Poorva karma: Patient s perineum is shaved properly. Proctoclysis enema will be given 2 hours prior to kshara procedure, to clear the rectum and anal canal, avoids soiling during surgery. Pradhana karma: Patient will be taken to lithotomy position. Painting and draping will be done. Lacal anaesthesia will be given. MAD and proctoscopy will be done. Anal canal and rectum will be inspected by inserting slit proctoscope through anal canal. With the help of slit proctoscope the kshara will be applied on the bleeding pilemass and wait for shatamatra kala ( approx. 100 seconds), later on the kshara on pilemass will be washed with nimbuswarasa (lemon juice). Once we see the pilemass turning in to pakwajambuphalavarna(bluish-black colour). Remove proctoscope and in yastimadhutailapichu per rectally and shift the patient to post-operative ward. Paschat karma : Daily hot water sitzbath will be given in morning and evening. Anulomana dravya will be given at night ie: two tablets of Anuloma-DS will be given before food at night.

5 Impact factor: 3.958/ICV: 4.10 ISSN: OBSERVATION AND RESULTS Assessment of patients will be done by two methods 1. Friedmann s test 2. Wilcoxon s signed rank test In this study the bonferroni correction obtained was The p value obtained below will be considered as significant andbelow will be considered as highly significant. If p value obtained is above or equals to will be considered as insignificant result. This test gives us overall effect of the treatment from before treatment to completion of study Wilcoxon s signed rank test is again applied to see the effect of treatment and to assess the action and effect of drug on arshas at different intervals, so we can know exactly at which period of treatment more effect of medicine is seen. After kshara karma the patient is followed for 5 visitings with detailed data and analysed by Wilcoxon signed rank test in 6 stages to assess the progress between each followup. Details of the followup is as mentioned below. BT AT = Before and after kshara application. Here only one day interval. AT - FU1= From AT to seventh day after kshara application. FU1 FU2= from 7 th day to 14 th day FU2 FU3= from 14 th to 21 st day FU3 FU4= from 21 st to 28 th day BT FU4 =comparison between BT to final follow-up on 28 th day. Results of kshara karma therapy on each criteria: EFFECT OF THERAPY ON PAIN PER RECTUM: As per the Friedman test there was a statistically significant difference in bleeding per rectum with x2(4) = , p= Post hoc analysis with Wilcoxon signed-rank tests was conducted with a Bonferroni correction applied resulting in a significance level set at p< Bleeding per rectum was increased in one patient and reduced in one, with no change in 28 patients on the next day of kshara karma. It means there no drastic change in pain on next day. So its insignificant between BT-AT. At the end of first week after the treatment pain reduced in 28 patients, increase in none and no change in 2 patients. The reduction in bleeding per rectum in 1st week was significant (Z=-4.789, p =0.000). so treatment has given highly significant results in first week of followup.in the 2nd week reduction in 10, increase in 0 and no change in 20 subjects

6 Impact factor: 3.958/ICV: 4.10 ISSN: was observed. There was statistically significant reduction in bleeding per rectum during 2nd week of treatment (Z = , p =0.002). In the 3rd week reduction in 2, increase in 0 and no change in 28 subjects was observed. There is no statistical significance of reduction in bleeding per rectum during 3rd week of treatment (Z = 1.414, p =1.57). In the 4th week reduction in 2 increase in 0 and no change in 28 was observed. There not much statistical significane in reduction in bleeding per rectum during 4th week of treatment (Z = 1.414, p =1.5).Over all when compared there was drastic reduction of pain in first week, moderately reduced in second week and mild reduction in 3rd and 4th week which is insignificant. So when compared to whole study, it was highly significant. Parameter Negative rank Positive rank ties Tota Z P Remark Pain N MR SR N MR SR l value value BT-AT NS AT-FU HS FU1-FU S FU2-FU NS FU3-FU NS BT-FU HS EFFECT OF THERAPY ON BLEEDING : There was a statistically significant difference in bleeding per rectum x2(4) = , p= Post hoc analysis with Wilcoxon signed-rank tests was conducted with a Bonferroni correction applied resulting in a significance level set at p< On first day after ksharakarma 14 subjects got relief from bleeding and 16 doesnot have any change with anyone increased in bleeding. P value obtained is so its significant. In 1st week 28 subjects had reduced bleeding and 2 were ties. Inreasesd bleeding is 0. P value is and it s significant. In second week 15 had relief, none aggravated and 15 were of no change. P value is , so it s significant. In 3rd week 8 had relief, 22 were ties and increased bleeding were none. P value is , so its significant. In 4th week 1 got relief 29 got ties ie; no change and increased bleeding were none. P value is 0.005, so study is significant. Over all p value is soits highly significant and whatever reduction is seen it is in first 2 weeks, later on there was no change. It reveals that in first 2 weeks kshara reduced the bleeding during defecation.

7 Impact factor: 3.958/ICV: 4.10 ISSN: Parameter Negative rank Positive rank ties Tota Z P Remark Bleeding N MR SR N MR SR l value value BT-AT HS AT-FU HS FU1-FU HS FU2-FU S FU3-FU NS BT-FU HS EFFECT OF THERAPY ON DEFECATION: There was a statistically significant difference in constipation x2(4) = , p= Post hoc analysis with Wilcoxon signed-rank tests was conducted with a Bonferroni correction applied resulting in a significance level set at p< on the next day of kshara karma6 subjects got relief from constipation and 23 got ties and one had increased constipation. P value is 0.059, so its insignificant. In 1st week 22 subjects had reduced constipation and 8 were ties. Inreasesd constipation is 0. P value is and its significant. In 2nd week 4 had relief, none aggravated and 26 were of no change. P value is 0.046, as p value is above , its insignificant. In 3rd week 2 had relief, 28 were ties and none had increase in constipation. P value is 0.157, so it is insignificant. In 4th week 0 got relief 30 got ties ie; no change and increased bleeding were none. P value is 1.000, so it is insignificant. Over all p value is soit s highly significant and whatever reduction is seen it is in first week, later on there was no change. It reveals that in first week kshara karma reduced the constipation during defecation. Parameter Negative rank Positive rank ti Tota Z P Remark Defecation N MR SR N MR SR es l value value BT-AT NS 3 AT-FU S FU1-FU NS FU2-FU NS FU3-FU NS BT-FU HS

8 Impact factor: 3.958/ICV: 4.10 ISSN: EFFECT OF THERAPY ON COLOUR OF PILEMASS: There was a statistically significant difference in colour of pilemass, x2(4) = , p= Post hoc analysis with Wilcoxon signed-rank tests was conducted with a Bonferroni correction applied resulting in a significance level set at p< on the next day of kshara karma 9 subjects got changes in colour of pilemass and 16 got ties and 5 had increased. P value is 0.285, so its insignificant. In 1st week 25 subjects had reduced colour and 5 were ties. Inreasesd colour is 0. P value is and its significant. In 2nd week 11 had changes/improved in colour, none increased and 19 were of no change. P value is 0.001, as p value is below , its significant. In 3rd week 11 had improvement, none aggravated and 19 were of no change. P value is 0.001, as p value is below , its significant. In 4th week 8 got improvement in colour, 22 were ties ie; no change and increased colour were none. P value is 0.005, so it is significant. Over all p value is soits highly significant. In first week the bleeding redishpilemass changed to blackish with drastic changes and remaining 3 following weeks there was gradual improvement. Parameter Negative rank Positive rank ties Tota Z P Remark Colour N MR SR N MR SR l value Value BT-AT NS 0 AT-FU HS FU1-FU S FU2-FU S FU3-FU S BT-FU HS EFFECT OF THERAPY ON TONICITY OF ANAL SPHINCTER : There was a statistically significant difference in colour of pile mass, x2(4) = , p= Post hoc analysis with Wilcoxon signed-rank tests was conducted with a Bonferroni correction applied resulting in a significance level set at p< in this study there was no significant effect on tonicity of anal sphincter in between follow-ups. But there was mild improvement in tonicity on overall treatment.

9 Impact factor: 3.958/ICV: 4.10 ISSN: Parameter Negative rank Positive rank ties Tota Z P Remark Tonicity N MR SR N MR SR l value value BT-AT S AT-FU HS FU1-FU NS FU2-FU NS FU3-FU NS BT-FU HS EFFECT OF THERAPY ON SIZE OF PILEMASS: There was a statistically significant difference in size of pilemass, x2(4) = , p= Post hoc analysis with Wilcoxon signed-rank tests was conducted with a Bonferroni correction applied resulting in a significance level set at p< on the next day of kshara karma 2 subjects got reduction in the size of pilemassand 28 got ties, none had increased size of pilemass. P value is 0.157, so its insignificant. In 1st week 27 subjects had reduced size and 3 were ties. Increase in size of pilemass is 0. P value is and its significant In 2nd week 11 had improvement, none aggravated and 19 were of no change. P value is 0.001, as p value is below , its significant. In 3rd week 17 had improvement, none aggravated and 13 were of no change. P value is , as p value is below , its significant. In 4th week 7 subjects got reduction in the size of pilemass, 23 were ties and increase in size of mass were none. P value is , so it is significant. Over all p value is soits highly significant. There was gradual reduction in size of pile mass, especially in first 3 weeks. Parameter Negative rank Positive rank ties Tota Z P Remark Size N MR SR N MR SR l value Value BT-AT NS AT-FU HS FU1-FU S FU2-FU HS FU3-FU S BT-FU HS

10 Impact factor: 3.958/ICV: 4.10 ISSN: DISCUSSION ON EFFECT OF TREATMENT: 1) Even though overall effect of treatment on pain during defecation is highly significant, it shows more reduction in first and second week followed by complete reduction of pain gradually till 3 rd week. So by three weeks pain has reduced completely. 2) Overall study shows highly significance in bleeding per rectum during defecation, but 1st and 2nd week stood highly significant. By the end of 3 rd week bleeding stopped gradually and completely. 3) Overall study shows highly significant result in colour of pilemass. Drastic changes are seen in 1 st week and gradual change till 4th week. Colour of pilemass becomes normal as mucosa by 3 rd week. 4) Overall study shows highly significant result in reduction of size of pilemass but it was irregular graph. It may be because of different sizes of pilemass taken in to study. If the study has been conducted on haemorrhoids of equal size, we could have got regular positive result. Small pilemass has reduced quickly and large mass took more time. 1 st, 2 nd and 3 rd degree pilemasses are not equally distributed. This might be the reason for irregular improvement. 5) Overall result on tonicity of anal sphincter was highly significant. All of it happened in 1 st week without any changes in later period. 6) Statistically overall result on defecation/constipation was highly significant, which took place in 1 st week with no change in later period of study. As per observations during followup s not so satisfactory changes. As kshara acts locally and constipation is dependant on how long feaces is stagnant in colon so hard stools form, bowel habits of patient and diet they take. Only 16.7% are vegetarians with fibre rich diet and 83.3% are mixed diet with less fibre diet. So kshara application on arsha can only reduce hypotonicity of anal sphincter but cannot reduce constipation. Mode of Action of Pratisaraneeya Kshara in Internal piles: Pratisaraneeya Kshara acts on haemorrhoids in two ways (1) It cauterizes and gradually scrapes the pile mass directly because of its corrosive nature. (2) It coagulates protein in haemorrhoidal plexus. The coagulation of protein leads todisintegration of haemoglobin into haemand globin. As a result of these actions it leads to decrease in the size of the pile mass. Further, necrosis of the tissue in the haemorrhoidal vein will

11 Impact factor: 3.958/ICV: 4.10 ISSN: occur. This necrosed tissue will slough out as blackish brown discharge for 3 to 7 days. The haem present in the slough gives the discharge its dark browncolour 11. CONCLUSION Kshara karma of Apamargadi teekshna pratisaraneeya kshara on ArdraArshas is highly significant in eliminating pain, bleeding, colour and size of ArdraArshas. Statistical improvement in tonicity of anal sphincter. No effect on constipation. REFERENCES: 1. Diagnosis and management ano rectal diseases, chaukhamba Sanskrit prathisthan, delhi, author: dr Praveen kumar and dr. k.k.sijoria, first edition 2002, chapter 4, page Sushruthasamhitha, Ayurveda tatva sandipika, ambika data, chaukambha Sanskrit sansthan, Varanasi, edition: reprint 2012, sutratana 11/12, p Dr.P.Hemantha Kumar, P.V.RameshBabu and M.Sahu, Effect of Pratisaraniya Kshara in themanagement of Haemorrhoids Journal of National Integrated Medical Association, June, 1998, Vol.XLno-6 Page no 9 to11, ISSN Surgery of anus, rectum and colon, john goligher, A.I.T.B.S publications,fifthedition,reprint 2001, treatment of haemorrhoids, p Shastri Ambikadata., Dr. Sutra Sthan. 12. Vol. 11. Shastri, Varanasi: Chaumbika Sanskrit Sansthan; Sushrutacharya Sushruta samhita, Ayurved Tatva Sandipika; p Shastri Ambikadata. Sutra Sthan. 25. Vol. 11. Varanasi: Chaumbika Sanskrit Sansthan; Sushrutacharya Sushruta samhita, Ayurved Tatva Sandipika; p Golighar J, Duthie H, Nixon H. 5th ed. Delhi: A. I. T. B. S. Publishers & Distributers; Surgery of Anus, Rectum & Colon; pp Sushruthasamhitha, Ayurveda tatva sandipika, ambika data, chaukambha Sanskrit sansthan, Varanasi, edition: reprint 2012, sutratana 11/6, p Chikitsa Sthan. 34. Vol. 14. Varanasi: Chaumbika Sanskrit Sansthan; Agnivesh, Charak Samhita, chakrapanidatta, Kashinath Shastri; p Vaidya shreeindradevatripathi: Gada nigraha edited by Gangasahayapandey, chaukhambhasamskrutasamsthana, Varanasi, edition reprint 2011, volume 3, chapter 7/60-65 slokas, page Dr.Avnishpathak, Dr.P.Hemanthkumar, International journal of ayurvedic medicine 2013, 4(1), 56-68, ISSN: