A Single Blind Clinical Study to Evaluate the Efficacy of Herbo-mineral Formulation in the Treatment of Arsha (Haemorrhoids)

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1 JR.A.S. Vol. XXXI, No.4, Oct. -Dec. 10 pp A Single Blind Clinical Study to Evaluate the Efficacy of Herbo-mineral Formulation in the Treatment of Arsha (Haemorrhoids) R. Govind Reddy', Anil Mangal, A. D. Jadhav', G. V. Venkateshwarlu" and G. S. Lavekar' Abstract A single blind clinical trial on the effect of Bheshaja chikitsa with Ayurvedic Herbo- Mineral formulations containing Kravyadi rasa, Triphala churna and Kasisadi taila was carried out on the patients of Arsha (Haemorrhoids) at the o.pdii.pd of R.A. Poddar Central Research Institute (Ay), Worli, Mumbai as per the C CR.A.S. protocol. A total number of 47 patients were studied and assessed. Statistically significant clinical improvement was observed in all the clinical findings (p<o.oool). The overall treatment response among the total cases studied, % cases had shown Good Response, % had shown Fair Response and 10.63% patients showed Poor (mild) Response and 2.12% patients showed no response. Hence it can be accomplished that Ayurvedic medical management with the selected drugs given in this trial is exceedingly beneficial in the management of Arsha (Haemorrhoids). Introduction The disease Arsha is a disorder of ano-rectal region with congested growths in the anal canal capable of disturbing the normal physiological functions of the body like an enemy i.e. Arivat pranan Srinoti iti Arshah: This disease is considered in Ayurveda as a local manifestation of systemic derangement or vitiation of doshas due to various etiological factors including unwholesome diet and deeds adversely effecting the Jathragni (Digestive enzymes) resulting in Mandagni (Hypo function 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

2 R. Govind Reddy et a/. turn leads to Vibandha (Constipation) which causes Injury to the anal canal during the forcible defecation. This provokes the dosha vikruti and paves the way in establishingarsha (Haemorrhoids). The clinical entity Arsha may be compared with Haemorrhoids in modem medicines, which are the varicose condition of the haemorrhoidal plexus of veins situated in the lower portion of the rectum and in the anal canal. The aetiology is still a matter of conjecture. The age-old factors enumerated as hereditary, laxity of external sphincter, anal infection, as principal cause and chronic constipation is the co-existing factor in majority of the patients. Goligher states that, the incidence of Haemorrhoids at least 50% of the people over the age of 50 years have some degree of haemorrhoidal symptoms and estimated men are to be affected roughly twice as frequently as women (Bennet et al 1963). The prevalence rate of this disease is 4.4% in ten million people. The faulty food habits and sedentary life style of modem man increases the incidence rate. Since the Haemorrhoids problem is not a threat to life, but causes considerable discomfort, enforced bed rest. Several surgical! conventional therapies are now in practice depending upon disease condition like Sclerotherapy, Rubber band ligation, anal dilatation, Photo coagulation, Cryo surgery, Haemorrhoidectomy etc. The various therapies shows that there is no universally acceptable technique in the management of Haemorrhoids and also have many manifold side effects from Haemorrhoidectomy like severe pain, anal incontinence and stricture etc. Sushruta, the father of ancient surgery has methodologically enumerated the disease and recommended four fold measures in the treatment of Arsha which are widely acceptable and more practical even to day viz. Bheshaja chikitsa (Medical management), Kshara chikitsa (Chemical or alkali cauterization), Agni karma (Thermal cauterization) and Shastra chikitsa (Surgical management). He also emphasized the selection of treatment method according to the nature of disease and constitution of patient. The medical management is effective mode in recent origin, involving the minimal vitiation of doshas with out any grave symptoms is amenable to medicines alone. Based on the treatment priority 86

3 A SINGLE BLIND CLINICAL STUDy. the present study has been planned with selective Herbo-mineral formulation as non-invasive therapy in Arsha (Hemorrhoids) with the aim to give relief systematically and symptomatically to the patient. A single blind study has been carried out at the level ofo.p.d/tp.d of R.A. Podar Central Research Institute (Ay.), Mumbai on 47 cases and the results were analyzed and assessed on various clinical parameters as given. Material and Methods A total number of 47 patients were taken for clinical trial for a period of21 days and a follow up was made at interval of 7 days during the study period and at interval of 15 days up to 3 months there after. The study has been carried out on the basis of selection criteria, exclusion of cases along with periodical observations and assessment of results. The clinical parameters viz. pain, tenderness, swelling, bleeding, itching, induration and constipation were assessed on the basis of scoring system i.e. 3,6,9 for mild, moderate and severe grade respectively for the purpose of statistical analysis. Selection of Patients Age: I6-60 years 87 Sex : Either sex (Male & Female) Painful/Pain less Bleeds / does not bleed. Anorectal Arsha (Hemorrhoids) Fresh / Previously operated Pile mass palpated / Seen by Per rectal examination or Proctoscopy Exclusion of Patients Patients with Malignancy Incontinence of Stool Cirrhosis of Liver- Portal hypertension Tuberculosis / Diabetes / Other Systemic disease Bleeding diathesis Multiple haemorrhoids Cardiac & Neurological diseases Trial Drugs: 1) Kravyadi rasa -500 mg three times in a day with warm water, 2) Tripbala Cboornam-5 gm at bedtime with warm water. 3) Kasisadi taila-2ml administered

4 R. Govind Reddy et al. per rectally before defecation once in the morning with the help of disposable syringe and plain rubber catheter number 7 for 21 days. Pathya ahara: Milk, Buttermilk, Ghee, Rice, Leafy vegetables, Citrus fruits, and plenty of oral fluids. Apathya ahara: Non-vegetarian diet, Spicy foods, Alcohol, Tobacco and Unwholesome preserved and canned food & Beverages. Criteria of Assessment :. Good Response: i) Above 75% to complete\ disappearance of known symptomatology in absence of other complications. ii) Considerable regression In the size of pile mass..:. Fair Response: i) 50% and above relief In presenting symptomatology..:. Poor Response: i) 25% and above relief In presenting symptomatology. ii) With negligible change in the size of pi le mass..:. No Response: No relief in presenting symptomatology and No change in the size of pile mass. :. Withdrawal from the study: i) Discontinuation of treatment during the trial. ii) Development of any complications. iii) Aggravation of the disease symptoms. iv) Any side effect of the drug Observations and Results Among 47 patients enrolled for clinical trial it was found that the incidence of disease is found more in the range of yrs of age (31.91 %). The sex wise incidence, Male (70.21 %) were almost double susceptible than Female (29.79%) (Table-I). ii) Some regression in the size of pile mass. 88

5 A SINGLE BLIND CLINICAL STUDy. Table-I Distribution of Age & Sex wise incidence of Arsha patients (n=47) Sl. No. Age group (in yrs) No. of Patients Total Percentage Male I Female ~% II 23.45% % % % Total 33(70.21%) 14(29.79%) % Fig.1 Distribution of cases according to age and sex (n=47) (/)... c Q) :;:J C\l a..... o o Z o AGE AND SEX DISTRIBUTION NO OF PATIENTS MALE NO OF PATIENTS FEMALE

6 R. Govind Reddy et a/. Duration Table-II of illness (n=47) SI. No Duration (in yrs) No. of Patients 1 < 1 yr > 3yrs 11 Total 47 Percentage 12.76% 38.29% 25.53% 23.4% 100% It was observed that maximum patients (38.29%) belong to one to two Fig.2 Duration DURATION years in chronicity followed by 2 to 3 years (25.53%) (Table-2). of illness (n=47) OF ILLNESS NO OF PATIENTS <1YR 1-2YR 2-3 YR >3YR 90

7 A SINGLE BLIND CLINICAL STUDy. Table-III Incidence of Prakriti (n=47) SI. No Prakriti No. of Pts Percentage 1 Vataja % 2 Pittaja % 3 Kaphaja 18 3R.29% 4 Vata Pittaja % 5 Vata Kaphaja % 6 Kapha Pittaja % Total % It was observed that Vata Pittaja and kaphaja Prakriti people were more susceptible (38.29%) to this disease. (Table-III). Fig.3 Distribution of patients acc. to incidence of Sharira Prakriti (n=47) PRAKRITI No. of Pts KaphaPittaja VataKaphaja 2 VataPittaja 18 Kaphaja 18 Pittaja 3 Vataja 2 91

8 R. Govind Reddy et a/. Table-IV Personal history (n=47) SI. No Personal history No. of Pts Percentage 1 Smoking % 2 Tobacco Chewing % 3 Non-Veg diet % 4 Spices intake % 5 Alcoholic % 6 Emotional stress % 7 Irregular bowel habits/ Constipation % As far as personal history is concerned the disease is more vulnerable to the patients having Emotional stress (53.19%), Non vegetarian diet (68.08%), Spicy food habits (61.7%) along with Irregular bowel habits (100%) (Table-IV). Fig.4 Distribution of cases according to Personal history (n=47) PERSONAL HISTORY... en z w ~ LL o z o IRREGULAR SMOKING TOBACO CHEWING NON VEG SPICES INTAKE ALCOHOLIC EMOTIONA L STRESS BOWEL HABIT ~----_I ~ ~r r----~.NO.OFPTS

9 A SINGLE BLIND CLINICAL STUDy. Table-V Distribution of type of Hemorrhoides (n=47) SI.No Type of hemorrhoides No.of patients Percentage External Internal Intero -External Total Among 47 cases studied, 63.83% cases were showed internal type of hemorrhoides followed by 36.17% having the intero external type and no cases were shown external type of hemorrhoides. Fig.5 Distribution of type of hemorrhoides '0 ~ external internal.'ntero-external 5 oa-'"type of hemorrhoides Table-VI Position of Haemorrhoids (n=47) SI. No 0' Clock No. of Patients Percentage 1 3'& 11' Clock % 2 5' Clock % 3 l' Clock % ' Clock % 3'& 1'Clock % Total

10 R. Govind Reddy et al. As regards to position of (46.80%) followed by 7'0 clock Haemorrhoids 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) en c tl.~ P-. 4- c: 0 z 20.3'&11 'clock.5'clock.7'clock 11'clock.3'&7'clock \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 BT AT R R < On statistical analysis the trial drugs effective in relieving the pain in Arsha have shown extremely significant patients (P<O.OOO 1) (Table-VII). Statistical Table-VIII analysis of Bleeding (n=47) BLEEDING MEANt-SO S.E.M tvalue PVALUE BT < AT l.40+l.75 94

11 A SINGLE BLIND CLINICAL STUDy. Bleeding was there in almost all cases in before treatment with the gradation of 35 cases were severe grade, 12 cases moderate grade bleeding. After treatment 27 patients have complete relief and 18 cases showed mild grade bleeding. The statistical analysis showed highly significant in controlling bleeding (P<O.OOO1) (Table-VIII). Table-IX Statistical 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 < AT \.34+\,74 Swelling was present in 46 cases (97.87%) before treatment, after treatment 28(59.57%) patients got complete relief. It is considered to be extremely statistically significant in reducing the swelling (P<O.OOO1) (Table-IX). Table-X Statistical analysis of Itching (n=47) -IT-C-H-IN-C'I'-M-E-A-N+-S-D-IS.E.M I t VALUE BT AT PVALUE < Itching was present in all 4 7 cases out of which 38 patients got complete relief from itching after treatment. The mean of before treatment minus after treatment equals % confidence interval of this difference: From 3.19 to Statistical Significance The two-tailed P value is less than By conventional criteria, this difference is considered to be extremely statistically significant in relieving Itching (P<O.OOO1)(Table-X). Table-XI Statistical analysis of Constipation (n=47) CONSTIPATION MEAN+SD I S.E.M t VALUE P VALUE BT < AT

12 R. Govind Reddy et al. Constipation or irregular bowel and 33 cases showed mild relief. It is habits were there in 47 cases (100%) considered to be highly significant in before treatment, after treatment 1] relieving constipation (P<O.OOOI) (23.40%) patients got complete relief (Table-X). Table-XII Statistical analysis of Tenderness (n=47) -T-E-N-D-E-R-N-E-S-S-,MEAN+SD I S.E.M, tvalue BT AT Tenderness was present in mild grade in 37 cases, moderate in 8 cases and severe grade in 2 patients before treatment, after treatment 40 (85.1 %) patients had shown complete relief and Table-XIII Statistical analysis of Induration PVALUE < cases showed mild tenderness. It is considered to be highly significant in relieving Tenderness (P<O.OOO1) (Table-XII) (n=47) INDURATION MEAN+-SD BT AT Induration was present in mild grade in 29 cases, moderate in 10 cases and severe grade in 7 patients before treatment, after treatment 45 (95.74%) patients got complete relief, and I case S.E.M tvalue PVALUE < showed mild grade indurations. It is consider being highly significant in relieving Induration (P<O.OOO1) (Table-XIII). Table-XIV Statistical analysis of change in Haemoglobin level (n=47) Hb% I Mean ± S.D I S.E.D Lii:~ p value B.T ± = A.T 12.96± P value and statistical significance The two-tailed P value equals by conventional criteria; this difference is considered to be very statistically significant. 96

13 A SINGLE BLIND CLINICAL STUDy. Table-XV Overall Treatment Response (n=47) Response No. of Pts Percentage Good Response % Fair Response % Poor Response % NO RESPONSE % TOTAL % It was observed the overall treatment response that among 47 cases studied, 51.06% cases showed good response, 36.17% cases showed fair response and 10.63% cases showed mild response and 02.12% patients showed no response (Table-XIV). Patient No.1 Patient No.2 Before Treatment After Treatment Before Treatment After Treatment Fig.7 Overall Treatment Response (n=47) NO RESPONSEt Poor Response Fair Response Good Response p- TREATMENT RESPONSE / / / / O Good Response Fair Response Poor Response NO RESPONSE,_ No. of Pis

14 R. Govind Reddy et al. Discussion and Conclusion The aetiology ofhaemorrhoids is still a matter of construe among modern proctologists. However, N esselrod.j, P. Opined that infection could be the principal cause of this disease. The other proctologists attribute haemorrhoids to Human's erect posture, heredity, absence of valves in portal system, straining at stool due to constipation, strenuous work, prolong standing, chronic illness etc. In the present study, it was observed that 68.08% patients were non-vegetarians and 61.70% patients were found of spicy food habits which would vitiate Jatharagni (Digestive enzymes) and cause irregular bowel habits (Constipation). Which is the principal cause of Ar s h a (Hemorrhoids) and its various pathological manifestations besides, it was also noted that 53.19% were having the history of emotional stress. Haemorrhoids are generally regarded as a surgical disease. The fact that so many operative and Parasurgical procedures are in vogue prove themselves that there is no standard treatment procedure available in the management of Arsha (Haemorrhoids) besides the surgical procedures involve risk factors and also have certain limitations. Keeping in view of above facts a non-invasive, conservative Ayurvedic medical management with Kravyadi rasa, Kasisadi taila and Triphala churna have been selected and studied. The ingredients of Kravyadi rasa (Ref: B.R) improve the pachakagni, since the main causative factor for Arsha is Mandagni and Amadosha. The Kravyadi rasa improves the digestive function and eliminates the Amadosha (Undigested toxic substance) from the body. The role of Kasisadi taila used for local application will help in producing soothing effect and will also help for easy descent of the faecal column. It have cytogenic and extra tissue debridement action and the main ingredient Kasisa (FeS04) having the properties of Vranaropana and Vrana shodhana in action thus helps in relieving pain swelling and local congestion and helps in faster healing of the eroded portion of the hemorrhoides. The Triphala churna contains Hareetaki (Terminalia chebula, Retz & Willd), Vibhitaki (Terminalia bellarica, Roxb) and Amalaki (Emblica officinalis, Gaertn) an important component exhibits laxative action by stimulating the intestinal mucus membranes by the secretion of mucus which enhances bowel movement and helps in smooth evacuation thus relieves the pain 98

15 A SINGLE BLIND CLINICAL STUDy. during defecation. The astringent properties, tannins and abundant Vitamin 'C' acts on blood capillaries, which help in arresting the bleeding. The combination of trial drugs would act systemically and local upon Ano-rectal piles and synergistic action reduces the varicosities of venous plexuses. Induces reduction in the haemorrhoidal mass and associated symptoms on minimum possible time to give relief to the patients. Out of 47 patients, 42 patients were followed up for 3 months. They did not have reported any complaints about the symptoms of the disease and there is any adverse reaction observed. Acknowledgement Authors are thankful to the Director General and Deputy Director (Tech) CCRAS, and New Delhi for providing necessary facilities for this clinical study. References Nesselrod,1. P. (1984). Clinical Proctology. Oxford and IBH publishing Co. 3 rli Edition. Burkitt, D.P. (1972). Varicose vein, Deep vein thrombosis (Epidemiology and Suggested Aetiology), B.M.J., 2, 556. and Haemorrhoids Bennet, R.C. et al. (1963). The late results of Haemorrhoids by Ligature and Excision, B.M.J, 2, 216. Madhavakara (1987). Madhava Nidanam, English translation by K.R.S.Murthy, Varanasi: Chowkhambha Orientalia. Susruta (1997). Susruta samhita commentary by Dalhana, Varanasi: Chowkhambha Orientalia. Edited by Vd.Jadavji Trikamji Acharya, 6 th Edn. Vaghbhata (1999). Astanga Hridayam commentary by Arunadatta, Delhi: Motilal Banarasidas Publisher's Pvt. Ltd. Edited by Shri Lal Chandra Vaidya, 1st Edn. Sharma, B.N. (1999). Ayurvedic management of Arshas (Haemorrhoids) - CCRAS Publication. 99

16 R. Govind Reddy et el. Govinda Dasa (2002). Bhaisajya Ratnavali with Vidyotini Hindi Vyakhya by Ambikadatta 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 Govinda Dasa (2001). Bhaishajya Ratnavali. vidyothini hindi vyakhya by Ambikadatta sastry. Varanasi: Choukhamha Sanskrit sansthan. 14th Edition. Nadakami, K.M. (1982). Indian Meteria Medica. Bombay: Popular Prakashan Pvt.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~ ~ fcnm ll<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 q ROil 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 ) 100