J.R.A.S. Vol. XXVII. No. 3-4. (2006) pp.81-91

THERAPEUTIC EVALUATION OF COMPOUNDAYURVEDIC FORMULATIONS IN THE

MANAGEMENT OFARSHA(HAEMORRHOIDS)-A CLINICAL STUDY

M.Mruthyumjaya Rao', Anukul Chandra Kar 2 and Pfshauacharya'

(Received on 6.7.2005)

In order to evaluate the efficacy of"Kaseesadi taila vasti Kankayana vati,Kravyadi Rasa. A bhayarishtam & Triphalachurna in the management of Arsha(Haemorrhoids) a single blind clinical trialwas conducted at Ana-Rectal Clinic.Central Research Institute (Ay.). Kolkataduring the period from August. 2000 toMarch 2004. This trial was conducted on182 patients of Arsha as per the protocoldesigned by CCRAS. New Delhi.

Out of 182 cases who received theabove regimen. 31. 31 percent cases gotcomplete relief. 29.12 percent got marked

relief. 20.32 percent got moderate relief.l. 09 percent got mild relief. 0.54 percentgot no relief while 15.93 percent weredropped out. It is concluded that the abovedrug regimen is effective in themanagement of Arsha.

Introduction

The haemorrhoid tissues (piles) arenormal structures which are thought to playsome part in anal continence. Their size,shape and details of anatom icalconfiguration vary in the population whodo not complain of any local problems. But

I. Asst.Director (Ay.). Central Research Institute(Ay.), Unit-I,Bhubaneswar-75I 009• 2. Research Officer(Ay.), CCRAS, New Delhi -110058 3. Research Officer(Ay.), Central

Research Institute(Ay.), Kolkata-700091 .

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M.Mruthyumjaya Rao et al.

any classification of clinical disease mustbe based on patients symptoms assigningfrom or caused by ill defined derangementof anal canal function. These symptomsmay occur singly or in combination: pain,bleeding, prolapse, mucus discharge, peri-anal itching, constipation and incontinenceto flatus and/or faeces.

The disease Arsha (Haemorrhoids) isa disorder of ana-rectal region is as old asmankind. The patients who complain ofpiles may have one or more of a numberof individual problems, that no singletreatment method can be advised for allpatients and that several different methodsmay achieve actually good result. Eventhough reference to this disease has beenfound in the Vedas, the disease has beendescribed i.e. about it's definition,aetiopathogenisis, symptoms, treatmentand it's line of treatment by Charak (1000B.C.) and Susruta (800 B.C.), hasdescribed 'Arsha' one among of themahagadas.

Sushruta, methodologically classifiedthe disease, and recommended differentdrug regimens, viz. Aushadha Chikitsa,Kshara Chikitsa, Agnikarma & Sashta-karma which are widely acceptable andpractically even today.

Based on the treatment modalitiesavailable in Ayurvedic text books, thepresent drug regimen is kept on trial on182 patients selected from Ano-rectalclinic of C.R.I.(Ay.), Kolkata as per the

selection/exclusion criteria laid down bythe Council and the results were analysedand assessed on various parameters.

Materials and Methods

The study was conducted as per theprotocol, designed on both Ayurvedic andmodern parameters. Essentially, the trialaimed to evaluate the efficacy of thisAyurvedic drug combination in terms ofthe days taken to check the bleeding as wellas associated symptoms and to see therecurrence of bleeding & other symptomsafter complete healing.

A) Selection of cases: A total no. of 182patients with complains of bleeding perrectum during and/or after the defecationwith or without other symptoms like,itching, discharge, constipation, with lorwithout pain were examined per-rectallyand confirmed by proctoscopicexamination were admitted for the study.The cases of strangulated pile masses, andhaemorrhoids associated with malignancywere excluded from the study. The caseswere randomly selected irrespective of age;sex, chronicity, prakrit i and type ofhaemorrhoids and follow-up was made atinterval of 7 days during the study periodof 21 days and at interval of 15 days up to6 weeks thereafter.

Graham-Stewart has suggested thattwo types of haem or rho ids i.e Vascular &Mucosal.

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THERAPEUTIC EVALUATION OF COMPOUND .....

Signs &symptoms

1'1 degree :Bleeding : It is usually brightred, unmixed with stool, may occur before,in the course of, or after defaecation andmay be expelled in large quantities.

2nd degree: Prolapse: A first degree pilesbleeds only but does not prolapse. Laterthey tend to remain prolapsed and requiredigital replacement.

Prolapse I : Does not require digitalmanipulation.

Prolapse 2: Requires digital manipulationfor the replacement.

Prolapse 3 : Cannot be replaced by digitalmanipulation.

3rd degree: Discharge: Irritation - Mucoiddischarge and pruritus alwaysaccompanied with prolapsed piles.

41h degree: Pain: Pain is absent in internalpiles. Pain occurs only when piles developsto thrombosis and other complications.Pain is always associated with Externalpiles as it is situated bellow the dentate lineand involved with inflammatory process.

51h degree: Anaemia: Due to excessbleeding patient develops with secondaryAnaemia.

B. Drug: I) Kaseesadi taila: 10 ml tobe administered per rectally half an hourbefore defaecation daily once in themorning with the help of syringe and plain

rubber catheter no. 7.

2) Kankayana vati: 500 mg. daily threetimes with warm water after food.

3) Kravyadi rasa: 500mg. daily threetimes with warm water after food.

4) Abhayarishtam: 25 ml twice dailywith luke warm water.

5) Triphala churna: 5 gm. at bed timewith warm water.

C. Supply of drugs: Both Kaseesaditail, Abhayarishtam and Kankayana vatiwere supplied by C.R.I.(Ay.),Cheruthuruthy, Kravyadi rasa byC.R.I.{Ay.), Kolkata and Triphala churnaby C.R.I.(Ay.), Patiala ofCCRAS.

D. Diet: To be taken : Ghee, milk, riceand plenty of liquids.

To avoid: Non-veg. and spicy foods.

E. Criteria adopted for assessment ofthe response of therapy: Since thebleeding is the main symptom in thebleeding haemorrhoids, the days taken toarrest the bleeding is noted along withalleviation of other associated symptomsand the resu Itwas assessed in the followingmanner.

I. Complete relief: When the bleedingis checked completely within 7 days oftherapy and complete disappe-arance ofassociated symptoms if any and norecurrence up to 6 weeks of the follow-

83

M.Mruthyumjaya Rao et al.

up.

2. Marked relief: When the bleeding ischecked after 7 days but Before 14 daysof therapy and complete disappearance ofassociated symptoms if any and norecurrence up to 6 weeks of the follow-up.

3. Moderate relief: Arrest of bleedingafter 14 days but before 21 days of thetherapy and complete disappearance ofassociated symptoms if any and norecurrence up to 6 weeks of follow-up.

4. Mild relief: Arrest of bleeding after21 days but before 30 days and completedisappearance of associated symptoms ofany and no recurrence up to 6 weeks offollow-up.

5. No relief: No checking of blood before30 days or checked after 30 days and/orrecurrence even after complete recovery

from the symptoms.

6. Drop out

1. Discontinuation of the treatmentduring the trial LAMA.

2. Development of any seriouscomplications.

3. Aggravation of the disease.

Results & Conclusions

a) Condition of patients on admission:(Summarized in table I)

Table ICondition of patients on admission

SI. ConditionA Age group

(in yrs.)

No. of patients (%)Male Female

Upto 2021-3031-4041-5051 & above

14(7.69)27(14.83)36(19.78)23(12.63)33(18.13)

9(4.94)9(4.94)14(7.69)9(4.94)8(4.39)

Total 133(73.07) 49(26.92)

B Prakriti ofpatient

VataPittaKapha

No. ofpatients (%)

71(39.01)97(53.29)14(7.69)

C Bowel habits No.ofpatients (%)

RegularConstipatedAlternate bowel habits

7(3.84)170(93.40)

5(2.74)

D Dietary habit

VegetarianNon-vegetarian

No. ofpatients (%)

11(6.04)171(93.95)

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THERAPEUTIC EVALUATION OF COMPOUND .....

Out of 182 patients admitted forclinical trial, 73.07percent were maleswhile 26.92 percent were females.Maximum of 27.47 percent of cases fallunder the age group of 31-40 yrs, whileminimum of 12.63 percent were the groupof up to 20 yrs. of age.

Among them 53.29 percent were ofpitta prakriti while minimum 7.69 percentwere of Kapha prakiriti, maximum no. ofpatients (93.4%) had constipated bowelhabits and almost all patients wererecorded as non-vegetarians (93.95%).

b) The characteristic of Arsha /haemorrhoids on admission:(Summarized in table II).

About 54.94 percent of patients had thedisease for at least one year, about 8.24percent of patients had previous analsurgery. The type of Arsha was internal in48.9 percent of patients; about 68 percentof haemorrhoids was positioned at 110

clock. A maximum no. of26.37 percent ofArsha was found to be pittaja typefollowed by Raktaja and Sannipataja withthe incidence of 24.17 percent and 22.52percent respectively.

Table IICharacteristics of Arsha I Haemorrhoids

on admission

Incidence ICharacteristics

% of Patients(n = 182)

a) Duration ofdisease (yr)

<I1-22-3

No.of patients(%)

100(54.94)57(31.31)18(9.89)7(3.84)>3

b) H/O previous No.of patientstreatment (%)Medical 75(41.20)Surgical 15(8.24)FreshINone 92(50.54)

Type of No. of patientsHaemorrhoids (%)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 patientsHaemorrhoids (%)(0' clock) (n=463)30 clock 110(60.43)50clock 73(40.10)70clock 83(45.60)lID clock 123(67.58)

c)

d)

e)

c) Clinical findings noticed on admission(Summarized in table III)

All patients had bleeding per rectum andprolapse in 43.40 percent, 37.36 percent hadpruritis, 83.51 percent had discomfort at perianal region, 25.82 percent had pain during!after defaecation, 41.2 percent had mucoiddischarge. About 10 percent had the meanhemoglobin of 4.5 gm.%, about 53.29percent had the mean Hb% of 7.2 gm%.percent while remaining patients of 36.81percent had either mild anaemia or normallevel of haemoglobin with mean of 10.3gm%. About 44.5 percent had moderatebleeding, about 12.08 percent and 43.4percent had mild and profuse bleeding perrectum respectively.

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M.Mruthyumjaya Rao at al.

Table IIIClinical features (signs & symptoms)

noticed on Admission ( n=182)

SI. Symptom

A. Bleeding(182=100%)Profuse/severeModeratemild

B. Prolapse of pilemasses

a) Prolapse: 1 (43)b) Prolapse: 2 (21)c) Prolapse: 3 (4)

C. Itching! Pruritis

D Discomfort

E. Pain

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 bleedingand 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 fromone week to four weeks. Out of I82 cases29 patients were dropped out from thestudy. About 31 percent patients hadhealing (complete relief) by 1stweek, 29.12percent had (marked reI ief) by two Weeks,20.32 percent had (moderate reliet) bythree weeks and about 1.09 percent had(mild relief) by four weeks.

Table IVSpeed of Recovery from bleeding and

other associated symptoms

Result / No. of patients %Recovery

Reliefby 1 week 57(31.31) 31.31

Reliefby 2 weeks 53(29.12) 29.12Reliefby 3 weeks 37(20.32) 20.32

Reliefby 4 weeks 02(1.09) 1.09

No reliefwithin 4 weeks 01(0.54) 0.54

Drop out /Recurrence 29(15.93) 15.93

Total 182(100.00) 100.00

(ii) (Table V)

Out of60 case who had complete relief,09 patients fall under the age up to the ageof 20, 20 cases under 31-40 yrs while

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THERAPEUTIC EVALUATION OF COMPOUND .....

minimum of 07 cases under the age of 21-30 yrs, Out of 53 cases who had markedrelief, maximum cases (21) were in the 31··40 yrs. age group, while minimum (03) upto the age of 20. Out of 37 cases who hadmoderate relief, the number was maximumof 11 each in the age groups of21 .30 & 51and above while minimum (2) in the groupupto to 20 yrs, Out of 2 patients who wereunder mild response category, 01 each inthe group of 51 and above and 21-30.

(iii)(Table VI)

Data shows maximum of 24 cases ofthe Pittaja type of Arsha had completerelief followed by Rakt ajai 18) andSannipataja (08) type. Under marked reliefcategory maximum of 13 patients each ofSannipataja and Raktaja type whileminimum of 3 cases of Sahaja type ofArsha. Under moderate response category12 cases were found to be Sannipataja, 07in Raktaja while 06 each to be of vataja,

kaphaja and pittaja type of Arsha.

(iv)(Table VII)

Analysis was made about the responsein reference to the duration of the diseaseand it shows the maximum number of 46cases who had complete relief had theduration of illness less than one year. Outof 53 cases who had marked relief, 25 hadillness less than one year followed by 21cases lip to 2 years. Out of 37 cases whohad moderate relief, maximum number of19 had the illness less than one year.

(v) (Table VIII)

A maximum no. of 27,31 & 20 ofinternal haernorrhoid cases had complete,marked and moderate relief respectivelyand a total of83 of cases ofintero-externalhaemorrhoids, 30 cases had complete, 20had marked, 17 had moderate relief whileminimum of 02 cases had mild relief.

Table VSpeed of recovery according to Age: (n=182)

Age group Results of the treatment (Percentage)

(in yrs.) Relief Relief Relief Relief No Drop Totalby I by 2 by 3 by 4 Relief Outweeks 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)21-30 7(3.84) 14(7.69) 11(6.04) 1(0.54) 0(0.00) 3(1.64) 53(29.12)31-40 20(10.98) 21(11.53) 5(2.74) 0(0.00) 1(0.54) 4(2.19) 45(24.72)41-50 14(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)

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M.Mruthyumjaya Rao et a/.

Table VISpeed of recovery according to type of Anita (n = 182)

Type of Results of the treatment (Percentage)

Arsha Relief Relief Relief Relief No Drop Totalby I by 2 by 3 by 4 Relief Outweeks 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 VIISpeed 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)1 - 2 11(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 andwere very fond of spicy, fast foods etc.which confirms the statement of "whentraditional diet in a community gives wayto more refined foods; the incidence ofhaemorrhoids always rises before that ofvaricose veins". The diagnosis ofArsha issimple but the choice of treatment is

It has also been observed from thestudy that there is a significantimprovement in hemoglobin levels after 45days of the therapy.

Discussion

In the present study it was found about

88

THERAPEUTIC EVALUATION OF COMPOUND .....

Table VIIISpeed of recovery according to the type of haemorrhoids (n=182)

Type of Results of the treatment (Percentage)

haemorrhoid Relief Relief Relief Relief No Drop Totalby I by 2 by 3 by 4 Relief Outweeks 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( 15.93) 182( 100.00)

Table IX

Improvement in the Hemoglobin level (n=182)

LevelofHb% Hemoglobin on After 30 After 45admission 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 besaid to be applicable to all the type ofArshal Haemorrhoids, which is capable tocure the disease.

The Haemorrhoids are regarded as asurgical disease and almost all operativeprocedures involve risk factors and hencehave their limitations. In view of above tofind out a non-invasive, conservativeAyurvedic drug regimen In the

management of Arsha and owing to theproperties of drugs, Kaseesadi taila,Kankayan vati, Kravyadi Rasa & Triphalachuma have been selected and kept on trial.

Kaseesadi taila for per rectalapplication will help in producing asoothing effect and will help easy descentof the faecal column. This process shouldbe carried out half an hour beforedefaecation daily irrespective of whether

89

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 & Sodhanaproperties, it heals the eroded portion ofthe haemorrhoid vessels and facilitates &promotes quick healing.

Both Kankayan vati and Kravyadi Rasenhance the power of Pachakagni i.edigestive fire; since the root cause of thedisease mentioned in Ayurveda is Ama ormetabolic disturbances, Kravyadi Ras wasselected in order to eliminate or treat thebasic cause i.e. amadosha to achieve theultimate/ better results of the treatment.

Some drug is needed to take care ofpatients evacuatory process especially whohave chronic or habitual constipationwhich is regarded as one of the majorcauses for the disease, hemorrhoidalbleeding. So Triphala churna &Abhayarishtam were selected for itslaxative as well carminative action on thebowel.

Since the earlier studies revealed therefined foods, fast foods and non veg. dietrises the incidence of hemorrhoidal

bleeding, the patients were kept on Milk,rice diet and plenty of liquids which alsohelps in the prevention of the recurrence.

On the basis of the results of this singleblind clinical trial, it is concluded that theearlier the chronicity of the disease, thequicker the healing and also minimum ornegligible chances of recurrence.

This trial drug combination will helpin the control of precipitation of thedisease, incidences of recurrences andcampi ications.

No Ayurvedic / Allopathic or any otherinvasive therapy excluding medicine iscomplication free, recurrence free hencetreatment with minimum complicationsand easy applications should be the rule inchanging a procedure in the managementof hemorrhoids.

Acknowledgement

The authors are highly indebted to theDirector, CCRAS, New Delhi for hisfinancial and technical support. We are alsothankful to the patients who gave theirconsent to call)' out the study.

REFERENCES

H.G. Anderson 1909 The after results of the operative treatmentofhaemorrhoids pre. med.J. 2: 1276.

90

THERAPEUTIC EVALUATION OF COMPOUND ., ...

Burkitt 1972 Varicose vein, Deep Vein thrombosis andHaemorrhoids (Epidemiology and SuggestedEtiology.) Br.MJ2.556.

L.P.Fielding et al. Management of patients with symptomatichaemorrhoids an introduction - (p.462-463).

M.Mruthyumjaya Rao et al. 2000 A clinical study on the effect of Kravyadi Ras, -,Kaseesadi taila vasti and Triphala churna inthe management of Arsha (Haernorrhoids);nusra.sx»: No. 1-2.(2004); p. 1-10.

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 SeriesOffice, Varanasi (commentary by Ambikadutta Sastri) .

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