JR.A.S. Vol. XXXI, No.4, Oct. -Dec. A Single Blind Clinical Study to …ayushportal.nic.in/pdf/20094.pdf · 2013-09-05 · External 00 30 00 2 Internal 63.83 3 Intero -External 17

JR.A.S. Vol. XXXI, No.4, Oct. -Dec. 10 pp. 85-100

A Single Blind Clinical Study toEvaluate the Efficacy of

Herbo-mineral Formulation in theTreatment of Arsha (Haemorrhoids)

R. Govind Reddy', Anil Mangal, A. D. Jadhav', G. V. Venkateshwarlu"and G. S. Lavekar'

AbstractA single blind clinical trial on the effect of Bheshaja chikitsa with

Ayurvedic Herbo- Mineral formulations containing Kravyadi rasa, Triphalachurna and Kasisadi taila was carried out on the patients of Arsha(Haemorrhoids) at the o.PDII.PD of R.A. Poddar Central ResearchInstitute (Ay), Worli, Mumbai as per the C CR.A.S. protocol. A total numberof 47 patients were studied and assessed. Statistically significant clinicalimprovement was observed in all the clinical findings (p<O.OOOl). Theoverall treatment response among the total cases studied, 51.06 % cases hadshown Good Response, 36.17 % had shown Fair Response and 10.63%patients showed Poor (mild) Response and 2.12% patients showed noresponse. Hence it can be accomplished that Ayurvedic medical managementwith the selected drugs given in this trial is exceedingly beneficial in themanagement of Arsha (Haemorrhoids).

Introduction

The disease Arsha is a disorderof ano-rectal region with congestedgrowths in the anal canal capable ofdisturbing the normal physiologicalfunctions of the body like an enemyi.e. Arivat pranan Srinoti itiArshah:This disease is considered in

Ayurveda as a local manifestation ofsystemic derangement or vitiation ofdoshas due to various etiologicalfactors including unwholesome dietand deeds adversely effecting theJathragni (Digestive enzymes)resulting in Mandagni (Hypofunction of digestive enzymes) in

I. Research Officer (Ay.), 2. Research Officer (Ay.), 3. Research Officer (Ay.) IIc R.A.Poddar Central Research Institute (fiy.) Worii Mumbai, 4. Research Officer (Ay.), R.R.I.,Bangalore, 5. Director General, CCRAS, New Delhi

85

R. Govind Reddy et a/.

turn leads to Vibandha(Constipation) which causes Injuryto the anal canal during the forcibledefecation. This provokes the doshavikruti and paves the way inestablishingArsha (Haemorrhoids).

The clinical entity Arsha may becompared with Haemorrhoids inmodem medicines, which are thevaricose condition of thehaemorrhoidal plexus of veinssituated in the lower portion of therectum and in the anal canal. Theaetiology is still a matter ofconjecture. The age-old factorsenumerated as hereditary, laxity ofexternal sphincter, anal infection, asprincipal cause and chronicconstipation is the co-existing factorin majority of the patients. Goligherstates that, the incidence ofHaemorrhoids at least 50% of thepeople over the age of 50 years havesome degree of haemorrhoidalsymptoms and estimated men are tobe affected roughly twice asfrequently as women (Bennet et al1963). The prevalence rate of thisdisease is 4.4% in ten million people.The faulty food habits and sedentarylife style of modem man increasesthe incidence rate.

Since the Haemorrhoidsproblem is not a threat to life, butcauses considerable discomfort,

enforced bed rest. Several surgical!conventional therapies are now inpractice depending upon diseasecondition like Sclerotherapy, Rubberband ligation, anal dilatation, Photocoagulation, Cryo surgery,Haemorrhoidectomy etc. Thevarious therapies shows that there isno universally acceptable techniquein the management of Haemorrhoidsand also have many manifold sideeffects from Haemorrhoidectomylike severe pain, anal incontinenceand stricture etc.

Sushruta, the father of ancientsurgery has methodologicallyenumerated the disease andrecommended four fold measures inthe treatment of Arsha which arewidely acceptable and more practicaleven to day viz. Bheshaja chikitsa(Medical management), Ksharachikitsa (Chemical or alkalicauterization), Agni karma(Thermal cauterization) and Shastrachikitsa (Surgical management).He also emphasized the selection oftreatment method according to thenature of disease and constitution ofpatient. The medical management iseffective mode in recent origin,involving the minimal vitiation ofdoshas with out any grave symptomsis amenable to medicines alone.

Based on the treatment priority

86

A SINGLE BLIND CLINICAL STUDy .

the present study has been plannedwith selective Herbo-mineralformulation as non-invasive therapyin Arsha (Hemorrhoids) with the aimto give relief systematically andsymptomatically to the patient.

A single blind study has beencarried out at the level ofO.P.D/tP.Dof R.A. Podar Central ResearchInstitute (Ay.), Mumbai on 47 casesand the results were analyzed andassessed on various clinicalparameters as given.

Material and Methods

A total number of 47 patientswere taken for clinical trial for aperiod of21 days and a follow up wasmade at interval of 7 days during thestudy period and at interval of 15days up to 3 months there after. Thestudy has been carried out on thebasis of selection criteria, exclusionof cases along with periodicalobservations and assessment ofresults. The clinical parameters viz.pain, tenderness, swelling, bleeding,itching, induration and constipationwere assessed on the basis of scoringsystem i.e. 3,6,9 for mild, moderateand severe grade respectively for thepurpose of statistical analysis.

Selection of Patients

• Age: I6-60 years

• Sex : Either sex (Male &Female)

• Painful/Pain less

• Bleeds / does not bleed.

• Anorectal Arsha (Hemorrhoids)

• Fresh / Previously operated

• Pile mass palpated / Seen byPer rectal examination orProctoscopy

Exclusion of Patients

• Patients with Malignancy

• Incontinence of Stool

• Cirrhosis of Liver- Portalhypertension

• Tuberculosis / Diabetes /Other Systemic disease

• Bleeding diathesis

• Multiple haemorrhoids

• Cardiac & Neurologicaldiseases

Trial Drugs:

1) Kravyadi rasa -500 mg threetimes in a day with warm water,

2) Tripbala Cboornam-5 gm atbedtime with warm water.

3) Kasisadi taila-2ml administered

87

R. Govind Reddy et al.

per rectally before defecationonce in the morning with thehelp of disposable syringe andplain rubber catheter number 7for 21 days.

Pathya ahara:

Milk, Buttermilk, Ghee, Rice,Leafy vegetables, Citrus fruits, andplenty of oral fluids.

Apathya ahara:

Non-vegetarian diet, Spicy foods,Alcohol, Tobacco and Unwholesome

preserved and canned food &

Beverages.

Criteria ofAssessment

•:. Good Response:

i) Above 75% to complete\disappearance of knownsymptomatology in absence ofother complications.

ii) Considerable regression In thesize of pile mass.

.:. Fair Response:

i) 50% and above relief Inpresenting symptomatology.

ii) Some regression in the size ofpile mass.

.:. Poor Response:

i) 25% and above relief Inpresenting symptomatology.

ii) With negligible change in thesize of pi le mass.

.:. No Response: No relief inpresenting symptomatology andNo change in the size of pilemass .

•:. Withdrawal from the study:

i) Discontinuation of treatmentduring the trial.

ii) Development of any complications.

iii) Aggravation of the diseasesymptoms .

iv) Any side effect of the drug

Observations and Results

Among 47 patients enrolled forclinical trial it was found that theincidence of disease is found more inthe range of 41-50 yrs of age(31.91 %). The sex wise incidence,Male (70.21 %) were almost doublesusceptible than Female (29.79%)(Table-I).

88


Table-IDistribution of Age & Sex wise incidence of Arsha patients (n=47)

Sl. No. Age group (in yrs) No. of Patients Total PercentageMale I Female

1 16-20 02 01 03 6.3~%2 21-30 09 02 II 23.45%3 31-40 10 03 13 27.65%4 41-50 09 06 15 31.91 %5 51-60 03 02 05 10.63%

Total 33(70.21%) 14(29.79%) 47 100%

Fig.1 Distribution of cases accordingto age and sex (n=47)

(/).•..•cQ)

:;:JC\la..•...ooZ

AGE AND SEX DISTRIBUTION

10987654321o

31-40 41-50 51-6016-20 21-30

• NO OF PATIENTS MALE 3• NO OF PATIENTS FEMALE

9 102 91 2 3 6 2

89


Table-IIDuration of illness (n=47)

SI. No Duration (in yrs) No. of Patients

1 < 1 yr 062 1-2 18

3 2-3 12

4 > 3yrs 11

Total 47

Percentage

12.76%

38.29%

25.53%

23.4%

100%

It was observed that maximumpatients (38.29%) belong to one to two

years in chronicity followed by 2 to 3years (25.53%) (Table-2).

Fig.2 Duration of illness (n=47)

12

DURATION OF ILLNESS

• NO OF PATIENTS

18

<1YR 1-2YR 2-3 YR >3YR

90


Table-IIIIncidence of Prakriti (n=47)

SI. No Prakriti No. of Pts Percentage

1 Vataja 02 04.25%

2 Pittaja 03 06.38%

3 Kaphaja 18 3R.29%

4 Vata Pittaja 18 38.29%

5 Vata Kaphaja 02 04.25%

6 Kapha Pittaja 01 02.12%

Total 47 100%

It was observed that Vata Pittajaand kaphaja Prakriti people were

more susceptible (38.29%) to thisdisease. (Table-III).

Fig.3 Distribution of patients acc. to incidenceof Sharira Prakriti (n=47)

• No. of Pts

PRAKRITI

KaphaPittaja

VataKaphaja 2

VataPittaja 18

Kaphaja 18

Pittaja 3

Vataja 2

91


Table-IVPersonal history (n=47)

SI. No Personal history No. of Pts Percentage

1 Smoking 20 42.55%

2 Tobacco Chewing 13 27.65%

3 Non-Veg diet 32 68.08%

4 Spices intake 29 61.7%

5 Alcoholic 15 31.91 %

6 Emotional stress 25 53.19%

7 Irregular bowel habits/

Constipation 47 100%

As far as personal history isconcerned the disease is morevulnerable to the patients havingEmotional stress (53.19%), Non

Fig.4 Distribution of cases according to Personal history (n=47)

vegetarian diet (68.08%), Spicy foodhabits (61.7%) along with Irregularbowel habits (100%) (Table-IV).

PERSONAL HISTORY

en•...zw

~LLooz

5045403530252015105o

IRREGULARTOBACO SPICES ALCOHOLIC EMOTIONA BOWEL

SMOKING CHEWING NON VEG INTAKE L STRESS HABIT

~----_I------+-----~-----+----~r-----+------r----~.NO.OFPTS 20 13 32 29 15 25 47

92


Table-VDistribution of type of Hemorrhoides (n=47)

SI.No Type of hemorrhoides No.of patients Percentage

External 0030

00

2 Internal 63.83

3 Intero -External 17 36.17

Total 47 100

Among 47 cases studied, 63.83%cases were showed internal type ofhemorrhoides followed by 36.17%

having the intero external type and nocases were shown external type ofhemorrhoides.

Fig.5 Distribution of type of hemorrhoides

5

30

25

£. 20'0

~ 15• external• internal.'ntero-External

10

oA-'"Type of hemorrhoides

Table-VIPosition of Haemorrhoids (n=47)

SI. No 0' Clock No. of Patients Percentage

1

2

34

5

3'& 11' Clock

5' Clock

l' Clock

11' Clock

3'& 1'Clock

22

0610

07

02

46.80%

12.76%

21.27%

14.89%

04.25%Total 47 100

93


As regards to position of (46.80%) followed by 7'0 clockHaemorrhoids more patients were (21.27% ) (Table-VI)found 3' & 11' 0 clock in position

Fig.6 Distribution of cases acc. to Clock position of Haemorrhoid (n=47)

5

25 22

20 .3'&11 'clock.5'clock.7'clock• 11'clock.3'&7'clocken 15c

tl.~P-.4-c:0 10z

0-\001III-

Clock position

Statistical analysis of Change in Clinical findings:Table-VII

Statistical analysis of Pain (n=47)

PAIN MEANt-SO S.E.M tVALUE PVALUE

BTAT

R.49+ 1.31.98+ 1.79

0.2R 23.25 <0.0001

On statistical analysis the trial drugs effective in relieving the pain in Arshahave shown extremely significant patients (P<O.OOO 1) (Table-VII).

Table-VIIIStatistical analysis of Bleeding (n=47)

BLEEDING MEANt-SO

BTAT

7.53+ 1.64

l.40+l.75

S.E.M

0.33

tVALUE

18.58

PVALUE

<0.0001

94


Bleeding was there in almost allcases in before treatment with thegradation of 35 cases were severegrade, 12 cases moderate gradebleeding. After treatment 27 patients

have complete relief and 18 casesshowed mild grade bleeding. Thestatistical analysis showed highlysignificant in controlling bleeding(P<O.OOO1) (Table-VIII).

Table-IXStatistical analysis of Swelling (n=47)

-S-W-E-L-L-IN-C-, MEAN+SD I S.E.M '-t-V-A-L-U-E----,,--P-V-A-L-U-E-

BT 5.23+2.02 0.27 14.4 <0.0001AT \.34+\,74

Swelling was present in 46 cases(97.87%) before treatment, aftertreatment 28(59.57%) patients gotcomplete relief. It is considered to be

Table-XStatistical analysis of Itching (n=47)

-IT-C-H-IN-C'I'-M-E-A-N+-S-D-IS.E.M I t VALUE

BT 3.82+0.63 0.23 13.87

AT 1.35+ 1.38

extremely statistically significant inreducing the swelling (P<O.OOO1)(Table-IX).

PVALUE

<0.0001

Itching was present in all 47 casesout of which 38 patients got completerelief from itching after treatment.

The mean of before treatmentminus after treatment equals 2.47.95% confidence interval of thisdifference: From 3.19 to 4.45.

Statistical Significance

The two-tailed P value is less than0.0001. By conventional criteria, thisdifference is considered to beextremely statistically significant inrelieving Itching (P<O.OOO1)(Table-X).

Table-XIStatistical analysis of Constipation (n=47)

CONSTIPATION MEAN+SD I S.E.M t VALUE PVALUE

BT 8.93+0.43 0.22 29.31 <0.0001

AT 2.48+1.57

95


Constipation or irregular bowel and 33 cases showed mild relief. It ishabits were there in 47 cases (100%) considered to be highly significant inbefore treatment, after treatment 1] relieving constipation (P<O.OOOI)(23.40%) patients got complete relief (Table-X).

Table-XIIStatistical analysis of Tenderness (n=47)

-T-E-N-D-E-R-N-E-S-S-,MEAN+SD I S.E.M , tVALUE

BT 3.76+ 1.59 0.22 14.82

AT 0.51+1.3

PVALUE

<0.0001

Tenderness was present in mildgrade in 37 cases, moderate in 8 casesand severe grade in 2 patients beforetreatment, after treatment 40 (85.1 %)patients had shown complete relief and

Table-XIIIStatistical analysis of Induration

INDURATION MEAN+-SD

BT 4.47+2.34AT 0.19+0.97

6 cases showed mild tenderness. It isconsidered to be highly significant inrelieving Tenderness (P<O.OOO1)(Table-XII)

(n=47)

S.E.M tVALUE PVALUE

0.33 12.94 <0.0001

Induration was present in mildgrade in 29 cases, moderate in 10 casesand severe grade in 7 patients beforetreatment, after treatment 45 (95.74%)patients got complete relief, and I case

Table-XIVStatistical analysis of change in Haemoglobin level (n=47)

Hb% I Mean ± S.D I S.E.D Lii:~ p value

showed mild grade indurations. It isconsider being highly significant inrelieving Induration (P<O.OOO1)(Table-XIII).

B.T 12.15 ± 2.129 0.082 2.7200 =0.0099

A.T 12.96± 1.970

P value and statistical significance

The two-tailed P value equals0.0099 by conventional criteria; this

difference is considered to be verystatistically significant.

96


Table-XVOverall Treatment Response (n=47)

Response No. of Pts Percentage

Good Response 24 51.06%Fair Response 17 36.17%Poor Response 05 10.63%

NO RESPONSE 01 02.12%

TOTAL 47 100%

It was observed the overalltreatment response that among 47cases studied, 51.06% cases showedgood response, 36.17% cases showed

Patient No.1

Before Treatment After Treatment

fair response and 10.63% casesshowed mild response and 02.12%patients showed no response(Table-XIV).

Patient No.2

Before Treatment

Fig.7 Overall Treatment Response (n=47)

After Treatment

TREATMENT RESPONSE

NO RESPONSE tPoor Response •Fair Response •Good Response

/ / / /p-

O 5 10 15 20 25

Good Response Fair Response Poor Response NO RESPONSE

,_ No. of Pis 24 17 5 1

97


Discussion and Conclusion

The aetiology ofHaemorrhoids isstill a matter of construe amongmodern proctologists. However,Nesselrod.J, P. Opined that infectioncould be the principal cause of thisdisease. The other proctologistsattribute haemorrhoids to Human'serect posture, heredity, absence ofvalves in portal system, straining atstool due to constipation, strenuouswork, prolong standing, chronicillness etc.

In the present study, it wasobserved that 68.08% patients werenon-vegetarians and 61.70% patientswere found of spicy food habits whichwould vitiate Jatharagni (Digestiveenzymes) and cause irregular bowelhabits (Constipation). Which is theprincipal cause of Ar s h a(Hemorrhoids) and its variouspathological manifestations besides, itwas also noted that 53.19% werehaving the history of emotional stress.

Haemorrhoids are generallyregarded as a surgical disease. The factthat so many operative and Para-surgical procedures are in vogue provethemselves that there is no standardtreatment procedure available in themanagement of Arsha(Haemorrhoids) besides the surgicalprocedures involve risk factors andalso have certain limitations. Keepingin view of above facts a non-invasive,

conservative Ayurvedic medicalmanagement with Kravyadi rasa,Kasisadi taila and Triphala churnahave been selected and studied.

The ingredients of Kravyadi rasa(Ref: B.R) improve the pachakagni,since the main causative factor forArsha is Mandagni and Amadosha.The Kravyadi rasa improves thedigestive function and eliminates theAmadosha (Undigested toxicsubstance) from the body.

The role of Kasisadi taila used forlocal application will help inproducing soothing effect and will alsohelp for easy descent of the faecalcolumn. It have cytogenic and extratissue debridement action and the mainingredient Kasisa (FeS04) having theproperties of Vranaropana and Vranashodhana in action thus helps inrelieving pain swelling and localcongestion and helps in faster healingof the eroded portion of thehemorrhoides.

The Triphala churna containsHareetaki (Terminalia chebula, Retz& Willd), Vibhitaki (Terminaliabellarica, Roxb) and Amalaki(Emblica officinalis, Gaertn) animportant component exhibits laxativeaction by stimulating the intestinalmucus membranes by the secretion ofmucus which enhances bowelmovement and helps in smoothevacuation thus relieves the pain

98


during defecation. The astringentproperties, tannins and abundantVitamin 'C' acts on blood capillaries,which help in arresting the bleeding.

The combination of trial drugswould act systemically and local uponAno-rectal piles and synergistic actionreduces the varicosities of venousplexuses. Induces reduction in thehaemorrhoidal mass and associatedsymptoms on minimum possible timeto give relief to the patients. Out of 47patients, 42 patients were followed up

for 3 months. They did not havereported any complaints about thesymptoms of the disease and there isany adverse reaction observed.

Acknowledgement

Authors are thankful to theDirector General and Deputy Director(Tech) CCRAS, and New Delhi forproviding necessary facilities for thisclinical study.

References

Nesselrod,1. P. (1984). Clinical Proctology. Oxford and IBH publishing Co. 3rli

Edition.

Burkitt, D.P. (1972). Varicose vein, Deep vein thrombosis and Haemorrhoids(Epidemiology and Suggested Aetiology), B.M.J., 2, 556.

Bennet, R.C. et al. (1963). The late results of Haemorrhoids by Ligature andExcision, B.M.J, 2, 216.

Madhavakara (1987). Madhava Nidanam, English translation byK.R.S.Murthy, Varanasi: Chowkhambha Orientalia.

Susruta (1997). Susruta samhita commentary by Dalhana, Varanasi:Chowkhambha Orientalia. Edited by Vd.Jadavji Trikamji Acharya, 6th Edn.

Vaghbhata (1999). Astanga Hridayam commentary by Arunadatta, Delhi:Motilal Banarasidas Publisher's Pvt. Ltd. Edited by Shri Lal Chandra Vaidya, 1stEdn.

Sharma, B.N. (1999). Ayurvedic management of Arshas (Haemorrhoids) -CCRAS Publication.

99

R. Govind Reddy et el.

Govinda Dasa (2002). Bhaisajya Ratnavali with Vidyotini Hindi Vyakhya byAmbikadatta Sastri, Varanasi: Chakhambha Publications. is"Edition.

M.M. Rao et al. (2006). A clinical study on the management of Arsha(Haemorrhoides) by Ayurvedic drug regimen - JRAS. Vol.XXV II, No.3-4.pp.48-58.

Govinda Dasa (2001). Bhaishajya Ratnavali. vidyothini hindi vyakhya byAmbikadatta sastry. Varanasi: Choukhamha Sanskrit sansthan. 14th Edition.

Nadakami, K.M. (1982). Indian Meteria Medica. Bombay: Popular PrakashanPvt.Ltd. 3rd revised and enlarged Edition. VoLl & II.

tll~I~'

~ w-r ~ ~ q~'(:qRr ~ • ~ ~~ q;y ~q)q) ~ 3Tun:Fr

(3lR. JnRl~ ~, ~ ~, ~. ~. \rfTtlCT, ~. ~cR~(NCj)~ ~. ~. C1~Cf)X)

~ ~ 1) ri m cf; ~~ 1) w~l~ ffi, ~q)C11 ~ ~

Cf) Ixfl x""llR Cfc;r ~ CI':H4:IffI '<SlPI \J1 -m-rrr c#t >IIJi IfUICf)C"11cpr 3l~ ~ fcnmll<lT I ~. ~. 3lR. ~. ~. ~ ID1{"fJiI'1~O\S'j cf; 3lJf1R ClctJiH 3l~ xl xl 311.

LJ1m q),>!~~~~ (~), ~, ~cf; ~f6~ll ~~~1) cgc;r 47 -<1fTllll -qx fcnm ll<lT I x""liftCZlc5l ~ ~ RI RPcti I cpr qROil Ji ~

(p>.0001) ID1{"f"§;3lTI RlRPCi11 ~ ~ ~ -crrR ,<lfTl~l· 1) 51.06% -<lf1l111·em

31<UT0fM, 36.17% em x""lIJiI;:;q 0fM ~ 10.63% em ~ 0fM Cl2TI2.12% '<lfTllll

em ~ ffi11 ~ fl1c;rr I

(Approved on 15-06-2009)

100

Documents

JR.A.S. Vol. XXXI, No.4, Oct. -Dec. A Single Blind Clinical Study to …ayushportal.nic.in/pdf/20094.pdf · 2013-09-05 · External 00 30 00 2 Internal 63.83 3 Intero -External 17