THERAPEUTIC EVALUATION OF COMPOUND AYURVEDIC FORMULATIONS IN THE MANAGEMENT OF A RSHA (HAEMORRHOIDS)-A CLINICAL STUDY

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1 J.R.A.S. Vol. XXVII. No (2006) pp THERAPEUTIC EVALUATION OF COMPOUND AYURVEDIC FORMULATIONS IN THE MANAGEMENT OF A RSHA (HAEMORRHOIDS)-A CLINICAL STUDY M.Mruthyumjaya Rao', Anukul Chandra Kar 2 and Pfshauacharya' (Received on ) In order to evaluate the efficacy of "Kaseesadi taila vasti Kankayana vati, Kravyadi Rasa. A bhayarishtam & Triphala churna in the management of Arsha (Haemorrhoids) a single blind clinical trial was conducted at Ana-Rectal Clinic. Central Research Institute (Ay.). Kolkata during the period from August to March This trial was conducted on 182 patients of Arsha as per the protocol designed by CCRAS. New Delhi. Out of 182 cases who received the above regimen percent cases got complete relief percent got marked relief percent got moderate relief. l. 09 percent got mild relief percent got no relief while percent were dropped out. It is concluded that the above drug regimen is effective in the management of Arsha. Introduction The haemorrhoid tissues (piles) are normal structures which are thought to play some part in anal continence. Their size, shape and details of anatom ical configuration vary in the population who do not complain of any local problems. But I. Asst.Director (Ay.). Central Research Institute(Ay.), Unit-I,Bhubaneswar-75I Research Officer(Ay.), CCRAS, New Delhi Research Officer(Ay.), Central Research Institute(Ay.), Kolkata

2 M.Mruthyumjaya Rao et al. any classification of clinical disease must be based on patients symptoms assigning from or caused by ill defined derangement of anal canal function. These symptoms may occur singly or in combination: pain, bleeding, prolapse, mucus discharge, perianal itching, constipation and incontinence to flatus and/or faeces. The disease Arsha (Haemorrhoids) is a disorder of ana-rectal region is as old as mankind. The patients who complain of piles may have one or more of a number of individual problems, that no single treatment method can be advised for all patients and that several different methods may achieve actually good result. Even though reference to this disease has been found in the Vedas, the disease has been described i.e. about it's definition, aetiopathogenisis, symptoms, treatment and it's line of treatment by Charak (1000 B.C.) and Susruta (800 B.C.), has described 'Arsha' one among of the mahagadas. Sushruta, methodologically classified the disease, and recommended different drug regimens, viz. Aushadha Chikitsa, Kshara Chikitsa, Agnikarma & Sashtakarma which are widely acceptable and practically even today. Based on the treatment modalities available in Ayurvedic text books, the present drug regimen is kept on trial on 182 patients selected from Ano-rectal clinic of C.R.I.(Ay.), Kolkata as per the selection/exclusion criteria laid down by the Council and the results were analysed and assessed on various parameters. Materials and Methods The study was conducted as per the protocol, designed on both Ayurvedic and modern parameters. Essentially, the trial aimed to evaluate the efficacy of this Ayurvedic drug combination in terms of the days taken to check the bleeding as well as associated symptoms and to see the recurrence of bleeding & other symptoms after complete healing. A) Selection of cases: A total no. of 182 patients with complains of bleeding per rectum during and/or after the defecation with or without other symptoms like, itching, discharge, constipation, with lor without pain were examined per-rectally and confirmed by proctoscopic examination were admitted for the study. The cases of strangulated pile masses, and haemorrhoids associated with malignancy were excluded from the study. The cases were randomly selected irrespective of age; sex, chronicity, prakrit i and type of haemorrhoids and follow-up was made at interval of 7 days during the study period of 21 days and at interval of 15 days up to 6 weeks thereafter. Graham-Stewart has suggested that two types of haem or rho ids i.e Vascular & Mucosal. 82

3 THERAPEUTIC EVALUATION OF COMPOUND... Signs &symptoms 1'1 degree :Bleeding : It is usually bright red, unmixed with stool, may occur before, in the course of, or after defaecation may be expelled in large quantities. and 2 nd degree: Prolapse: A first degree piles bleeds only but does not prolapse. they tend to remain prolapsed digital replacement. Later and require Prolapse I : Does not require digital manipulation. Prolapse 2: Requires digital manipulation for the replacement. Prolapse 3 : Cannot be replaced manipulation. by digital 3 rd degree: Discharge: Irritation - Mucoid discharge and pruritus always accompanied with prolapsed piles. 41h degree: Pain: Pain is absent in internal piles. Pain occurs only when piles develops to thrombosis and other complications. Pain is always associated with External piles as it is situated bellow the dentate line and involved with inflammatory process. 5 1h degree: Anaemia: Due to excess bleeding patient develops Anaemia. with secondary B. Drug: I) Kaseesadi taila: 10 ml to be administered per rectally half an hour before defaecation daily once in the morning with the help of syringe and plain rubber catheter no. 7. 2) Kankayana vati: 500 mg. daily three times with warm water after food. 3) Kravyadi rasa: 500mg. daily three times with warm water after food. 4) Abhayarishtam: 25 ml twice daily with luke warm water. 5) Triphala churna: 5 gm. at bed time with warm water. C. Supply of drugs: Both Kaseesadi tail, Abhayarishtam and Kankayana vati were supplied by C.R.I.(Ay.), Cheruthuruthy, Kravyadi rasa by C.R.I.{Ay.), Kolkata and Triphala churna by C.R.I.(Ay.), Patiala ofccras. D. Diet: To be taken : Ghee, milk, rice and plenty of liquids. To avoid: Non-veg. and spicy foods. E. Criteria adopted for assessment of the response of therapy: Since the bleeding is the main symptom in the bleeding haemorrhoids, the days taken to arrest the bleeding is noted along with alleviation of other associated symptoms and the resu It was assessed in the following manner. I. Complete relief: When the bleeding is checked completely within 7 days of therapy and complete disappe-arance of associated symptoms if any and no recurrence up to 6 weeks of the follow- 83

4 M.Mruthyumjaya Rao et al. up. Results & Conclusions 2. Marked relief: When the bleeding is checked after 7 days but Before 14 days of therapy and complete disappearance of associated symptoms if any and no recurrence up to 6 weeks of the follow-up. 3. Moderate relief: Arrest of bleeding after 14 days but before 21 days of the therapy and complete disappearance of associated symptoms if any and no recurrence up to 6 weeks of follow-up. 4. Mild relief: Arrest of bleeding after 21 days but before 30 days and complete disappearance of associated symptoms of any and no recurrence up to 6 weeks of follow-up. 5. No relief: No checking of blood before 30 days or checked after 30 days and/or recurrence even after complete recovery from the symptoms. 6. Drop out 1. Discontinuation of the treatment during the trial LAMA. 2. Development of any serious complications. 3. Aggravation of the disease. a) Condition of patients on admission: (Summarized in table I) Table I Condition of patients on admission SI. Condition A B Age group (in yrs.) Upto & above No. of patients (%) Male 14(7.69) 27(14.83) 36(19.78) 23(12.63) 33(18.13) Female 9(4.94) 9(4.94) 14(7.69) 9(4.94) 8(4.39) Total 133(73.07) 49(26.92) Prakriti of Vata Pitta patient Kapha No. of patients (%) 71(39.01) 97(53.29) 14(7.69) C Bowel habits No.of Regular Constipated Alternate bowel habits D Dietary habit patients (%) 7(3.84) 170(93.40) 5(2.74) No. of patients (%) Vegetarian Non-vegetarian 11(6.04) 171(93.95) 84

5 THERAPEUTIC EVALUATION OF COMPOUND... Out of 182 patients admitted for clinical trial, 73.07percent were males while percent were females. Maximum of percent of cases fall under the age group of yrs, while minimum of percent were the group of up to 20 yrs. of age. Among them percent were of pitta prakriti while minimum 7.69 percent were of Kapha prakiriti, maximum no. of patients (93.4%) had constipated bowel habits and almost all patients were recorded as non-vegetarians (93.95%). b) The characteristic of Arsha / haemorrhoids on admission: (Summarized in table II). About percent of patients had the disease for at least one year, about 8.24 percent of patients had previous anal surgery. The type of Arsha was internal in 48.9 percent of patients; about 68 percent of haemorrhoids was positioned at 11 0 clock. A maximum no. of26.37 percent of Arsha was found to be pittaja type followed by Raktaja and Sannipataja with the incidence of percent and percent respectively. Table II Characteristics of Arsha I Haemorrhoids on admission Incidence I Characteristics a) Duration of disease (yr) <I >3 % of Patients (n = 182) No.of patients (%) 100(54.94) 57(31.31) 18(9.89) 7(3.84) b) H/O previous No.of patients treatment (%) Medical 75(41.20) Surgical 15(8.24) FreshINone 92(50.54) c) d) e) Type of No. of patients Haemorrhoids (%) External 10(5.49) Internal 89(48.90) Intero external 83(45.60) Type of Arsha No.of patients (%) Vataja 27(14.83) Pittaja 48(26.37) Kaphaja 17(9.34) Sannipataja 41(22.52) Raktaja 44(24.17) Sahaja 5(2.74) Position of No. of patients Haemorrhoids (%) (0' clock) (n=463) 30 clock 110(60.43) 50clock 73(40.10) 7 0 clock 83(45.60) lid clock 123(67.58) c) Clinical findings noticed on admission (Summarized in table III) All patients had bleeding per rectum and prolapse in percent, percent had pruritis, percent had discomfort at peri anal region, percent had pain during! after defaecation, 41.2 percent had mucoid discharge. About 10 percent had the mean hemoglobin of 4.5 gm.%, about percent had the mean Hb% of 7.2 gm%. percent while remaining patients of percent had either mild anaemia or normal level of haemoglobin with mean of 10.3 gm%. About 44.5 percent had moderate bleeding, about percent and 43.4 percent had mild and profuse bleeding per rectum respectively. 85

6 M.Mruthyumjaya Rao at al. Table III Clinical features (signs & symptoms) SI. noticed on Admission ( n=182) Symptom A. Bleeding (182=100%) Profuse/severe Moderate mild B. Prolapse of pile masses a) Prolapse: 1 (43) b) Prolapse: 2 (21) c) Prolapse: 3 (4) C. Itching! Pruritis D E. Pain Discomfort No. of patients (%) 79(43.40) 81(44.50) 22(12.08) 68(37.36) 53(29.12) 152(83.51 ) 47(25.82) F. Discharge (mucoid) 75( 41.20) G. Anaemia Severe (Hb%<7 gm.%) Moderate (b% 7-IOgm) Mild/normalcy (Hb%> 1Ogm%) 18(9.89) (mean Hb=4.5) 97(53.29) (mean Hb=7.2) 67(36.81) (mean Hb=IO.3) d) The speed of recovery from bleeding and other associated symptoms (Summarized in Tables from IV to IX) : (i) (Table IV) Healing took place in 149 patients with varying degree of duration starting from one week to four weeks. Out of I82 cases 29 patients were dropped out from the study. About 31 percent patients had healing (complete relief) by 1stweek, percent had (marked rei ief) by two Weeks, percent had (moderate reliet) by three weeks and about 1.09 percent had (mild relief) by four weeks. Table IV Speed of Recovery from bleeding and other associated symptoms Result / No. of patients % Recovery Relief by 1 week 57(31.31) Relief by 2 weeks 53(29.12) Relief by 3 weeks 37(20.32) Relief by 4 weeks 02(1.09) 1.09 No relief within 4 weeks 01(0.54) 0.54 Drop out / Recurrence 29(15.93) Total 182(100.00) (ii) (Table V) Out of60 case who had complete relief, 09 patients fall under the age up to the age of 20, 20 cases under yrs while 86

7 THERAPEUTIC EVALUATION OF COMPOUND... minimum of 07 cases under the age of yrs, Out of 53 cases who had marked relief, maximum cases (21) were in the yrs. age group, while minimum (03) up to the age of 20. Out of 37 cases who had moderate relief, the number was maximum of 11 each in the age groups of21.30 & 51 and above while minimum (2) in the group upto to 20 yrs, Out of 2 patients who were under mild response category, 01 each in the group of 51 and above and (iii)(table VI) Data shows maximum of 24 cases of the Pittaja type of Arsha had complete relief followed by Rakt ajai 18) and Sannipataja (08) type. Under marked relief category maximum of 13 patients each of Sannipataja and Raktaja type while minimum of 3 cases of Sahaja type of Arsha. Under moderate response category 12 cases were found to be Sannipataja, 07 in Raktaja while 06 each to be of vataja, kaphaja and pittaja (iv)(table VII) type of Arsha. Analysis was made about the response in reference to the duration of the disease and it shows the maximum number of 46 cases who had complete relief had the duration of illness less than one year. Out of 53 cases who had marked relief, 25 had illness less than one year followed by 21 cases lip to 2 years. Out of 37 cases who had moderate relief, maximum number of 19 had the illness less than one year. (v) (Table VIII) A maximum no. of 27,31 & 20 of internal haernorrhoid cases had complete, marked and moderate relief respectively and a total of83 of cases ofintero-external haemorrhoids, 30 cases had complete, 20 had marked, 17 had moderate relief while minimum of 02 cases had mild relief. Table V Speed of recovery according to Age: (n=182) Age group Results of the treatment (Percentage) (in yrs.) Relief Relief Relief Relief No Drop Total by I by 2 by 3 by 4 Relief Out weeks weeks weeks weeks Up to 20 9(4.94) 3(1.64) 2(1.09) 0(0.00) 0(0.00) 9(4.94) 27(14.83) (3.84) 14(7.69) 11(6.04) 1(0.54) 0(0.00) 3(1.64) 53(29.12) (10.98) 21(11.53) 5(2.74) 0(0.00) 1(0.54) 4(2.19) 45(24.72) (7.69) 7(3.84) 8(4.39) 0(0.00) 0(0.00) 2(1.09) 48(26.37) 51 & above 10(5.49) 8(4.39) 11(6.04) 1(0.54) 0(0.00) 11(6.04) 35(19.23) Total 60(32.96) 53(29.12) 37(20.32) 2(1.09) 1(0.54) 29(15.93) 182(100.00) 87

8 M.Mruthyumjaya Rao et a/. Table VI Speed of recovery according to type of Anita (n = 182) Type of Results of the treatment (Percentage) Arsha Relief Relief Relief Relief No Drop Total by I by 2 by 3 by 4 Relief Out weeks weeks weeks weeks Vataj 5(2.74) 6(3.29) 6(3.29) 1(0.54) 1(0.54) 8(4.39) 27(14.83) Pittaja 24(13.18) 8(4.39) 6(3.29) 0(0.00) 0(0.00) 8(4.39) 48(26.37) Kaphaj 3( 1.64) 10(5.49) 6(3.29) 0(0.00) 0(0.00) 0(0.00) 17(9.34) Sannipataja 8(4.39) 13(7.14) 12(6.59) 1(0.54) 0(0.00) 7(3.84) 41(22.52) Raktaj 18(9.89) 13(7.14) 7(3.84) 0(0.00) 0(0.00) 6(3.29) 44(24.17) Sahaj 2( 1.09) 3(1.64) 0(0.00) 0(0.00) 0(0.00) 0(0.00) 5(2.74) Total 60(32.96) 53(29.12) 37(20.32) 2(1.09) 1(0.54) 29(15.93) 182(100.00) Table VII Speed of recovery according to the duration of the illness (n=182) Duration of Results of the treatment ( Percentage) illness Relief Relief Relief Relief No Drop Total (in yrs.) by I by 2 by 3 by 4 Relief Out weeks weeks weeks weeks Upto 1 46(25.27) 25(13.73) 19(10.43) 0(0.00) 0(0.00) 10(5.49) 100(54.94) (6.04) 21(11.53) 16(8.79) 0(0.00) 1(0.54) 8(4.39) 57(31.31 ) 2-3 2(1.09) 5(2.74) 2(1.09) 1(0.54) 0(0.00) 4«2.19) 18(9.89) 3 & above 1(0.54) 2( 1.09) 0(0.00) 1(0.54) 0(0.00) 4(2.19) 7(3.84) Total 60(32.96) 53(29.12) 37(20.32) 2(1.09) 1(0.54) 29(15.93) 182(100.00) (vi) (Table IX) 93.95% patients were non-vegetarians and were very fond of spicy, fast foods etc. It has also been observed from the which confirms the statement of "when study that there is a significant traditional diet in a community gives way improvement in hemoglobin levels after 45 to more refined foods; the incidence of days of the therapy. haemorrhoids always rises before that of Discussion varicose veins". The diagnosis ofarsha is simple but the choice of treatment is In the present study it was found about 88

9 THERAPEUTIC EVALUATION OF COMPOUND... Table VIII Speed of recovery according to the type of haemorrhoids (n=182) Type of Results of the treatment (Percentage) haemorrhoid Relief Relief Relief Relief No Drop Total by I by 2 by 3 by 4 Relief Out weeks weeks weeks weeks External 3(1.04) 2(1.09) 0(0.00) 0(0.00) 0(0.00) 5(2.74) 10(5.49) Internal 27(14.83) 31(17.03) 20(10.98) 0(0.00) 1(0.54) 9(4.94) 89(48.90) lntero-ext. 30(16.48) 20(10.98) 17(9.34) 2(1.09) 0(0.00) 15(8.24) 83(45.60) Total 60(32.96) 53(29.12) 37(20.32) 2(1.09) 1(0.54) 29( ) 182( ) Table IX Improvement in the Hemoglobin level (n=182) LevelofHb% Hemoglobin on After 30 After 45 admission days days <7gm.% 18(9.89) 12(6.59) 7(3.84) (mean=4.5) (mean=5.8) (mean=6.9) 7-IOgm.% 97(53.29) 138(75.82) 161(88.46) (mean=7.2) (mean=8.5) (mean=9.8) >10 gm.% 67(36.81 ) 32(17.58) 14(7.69) (mean=10.3) (mean= 11.00) (mean=13.5) difficult, because one therapy can not be said to be applicable to all the type of Arshal Haemorrhoids, which is capable to cure the disease. The Haemorrhoids are regarded as a surgical disease and almost all operative procedures involve risk factors and hence have their limitations. In view of above to find out a non-invasive, conservative Ayurvedic drug regimen In the management of Arsha and owing to the properties of drugs, Kaseesadi taila, Kankayan vati, Kravyadi Rasa & Triphala chuma have been selected and kept on trial. Kaseesadi t aila for per rectal application will help in producing a soothing effect and will help easy descent of the faecal column. This process should be carried out half an hour before defaecation daily irrespective of whether 89

10 M.Mruthyumjaya Rao et a/. the patient moves his bowels once or twice. The main ingredient is Kaseesa (Cu S04) and due to its Vrana Ropana & Sodhana properties, it heals the eroded portion of the haemorrhoid vessels and facilitates & promotes quick healing. Both Kankayan vati and Kravyadi Ras enhance the power of Pachakagni i.e digestive fire; since the root cause of the disease mentioned in Ayurveda is Ama or metabolic disturbances, Kravyadi Ras was selected in order to eliminate or treat the basic cause i.e. amadosha to achieve the ultimate/ better results of the treatment. Some drug is needed to take care of patients evacuatory process especially who have chronic or habitual constipation which is regarded as one of the major causes for the disease, hemorrhoidal bleeding. So Triphala churna & Abhayarishtam were selected for its laxative as well carminative action on the bowel. Since the earlier studies revealed the refined foods, fast foods and non veg. diet rises the incidence of hemorrhoidal bleeding, the patients were kept on Milk, rice diet and plenty of liquids which also helps in the prevention of the recurrence. On the basis of the results of this single blind clinical trial, it is concluded that the earlier the chronicity of the disease, the quicker the healing and also minimum or negligible chances of recurrence. This trial drug combination will help in the control of precipitation of the disease, incidences of recurrences and campi ications. No Ayurvedic / Allopathic or any other invasive therapy excluding medicine is complication free, recurrence free hence treatment with minimum complications and easy applications should be the rule in changing a procedure in the management of hemorrhoids. Acknowledgement The authors are highly indebted to the Director, CCRAS, New Delhi for his financial and technical support. We are also thankful to the patients who gave their consent to call)' out the study. REFERENCES H.G. Anderson 1909 The after results of the operative treatment ofhaemorrhoids pre. med.j. 2:

11 THERAPEUTIC EVALUATION OF COMPOUND.,... Burkitt 1972 Varicose vein, Deep Vein thrombosis and Haemorrhoids (Epidemiology and Suggested Etiology.) Br.MJ L.P.Fielding et al. Management of patients with symptomatic haemorrhoids an introduction - (p ). M.Mruthyumjaya Rao et al A clinical study on the effect of Kravyadi Ras, -, Kaseesadi taila vasti and Triphala churna in the management of Arsha (Haernorrhoids); nusra.sx»: No. 1-2.(2004); p Rob & Smith Operative surgery Lippin cort company-a" edition. B.N.Sharma 1999 Ayurved ic management of Arsha (Heamorrhoids )-CCRAS Publication. Sushruta Susruta Samhita Chawkamba Sanskrit Series Office, Varanasi (commentary by Ambika dutta Sastri). ~ 'ti1,<i~1 am ~ q)iq)lli~qc!), wclfi~ ffi q)1~')t1i~ ~ ~ -qct ~q)c't1 ~ cpr ~ -qx ~ ~ ~. ~~~1I XlCf, 31jq)C\<>1 ~ ct>x, tfi ~gl:q14 ~ ~ '<CfC1I~f lr 4)j4)llF1Qc?l. wclli~ ffi, 4)1f11fll~ (fc;r m ~ ~Lf> (11 ~ em wnq lr ~ fct:>m 'lfm ~ I cgc>f 182 '<1 f1l11'j lr 3T'Ul1R FcPm 'lfm I ~ 3l'Ul1R ~ RI Fcl>fHI em wncr 3l'Ul1R %g «Rl erut ~ m- cfi ~ ~ em ~ 3ITtTR ~ 'lfm ~ I RlFcl>MI ~ ~ m qffi 182 '<1 ftt I'j ~ ~ 110 '<1f1l?~'j ~ ~ ~ 'ff~ ~ '<1f1l11'j ~, fli Ji I;:;q t1'< ~ fli SO! I;:;q wnq -qrm <rm ~ I 91