REPORT ON THE CLINICAL TRIAL
OF
"PIRRHOIDS TABLETS" IN PILES DISORDERS

INTRODUCTION :

Arsa or Haemorrhoids (Greek; Haima = Blood, Rhoo=Flowing) commonly known as Arsa or PILES (Latin pila‑‑a ball) are dilated veins occurring in relation to anus. It may be external or internal, i.e., external or internal to anal orifice. The external variety is covered by skin, while internal variety lies beneath anal mucous membrane. When the two varieties are associated, called ENTEROEXTERNAL haemorrhoids or piles.

Haemorrhoids are very common in male and female. About half of the population have haemorrhoids by age of 50 years. Haemorrhoids are also common among pregnant women. The pressure of the faetus in the abdomen, as well as hormonal changes cause haernorrhoidal vessels to enlarge. Anorectal varices are commonly found in patients with portal hypertension also.

Haemorrhoids or piles arises from congestion of the internal or external venous plexus around and anal canal. They are extremely common in adult. The exact aetiology is unknown. Although they are associated with constipation and straining and may develop for the first time in pregnancy.

The first degree piles bleeds, while second degree piles prolapse, but retract spontaneously. The third degree piles are those which requires manual placements after prolapsing. Other symptoms includes pain, pruritus‑ani and mucous discharge.

Haemorrhoids (piles) may be the symptom of some other conditions and this important fact must be remembered as Carcinoma of rectum, piles during pregnancy, from straining at micturition and ftom chronic constipation. The common symptoms of Haemorrhoids or piles are bright red painless bleeding, Mucous discharge, rectal prolapse, pain only on proIapse, pain in rectum, anaemia, and weakness etc.

Modem medicine prefers surgery for treatment of piles. But in Ayurvedic classics there are so many medicine useful to cure piles or Haemorrhoids successfully as well as with no/least side effects. PIRRHOIDS is an Ayurvedic formulation, prepared by SHREE BAIDYANATH AYURVEDA BHAWAN, 1, GUPTA LANE, KOLKATA‑700006, was trialed in patients of piles disorders to know the efficacy of the drug clinically.

AIM AND OBJECT :

To evaluate the therapeutic value of "PIRRHOIDS " tablets in the patients of Piles disorders, the present clinical trial was undertaken. Total 44 cases have been included in this study. Who were studied in different groups viz. trial group and control group. Trial group included 32 patients to whom PIRRHOIDS, trial drug was administered. Control group included 12 patients to whom PLACEBO was administered in the similar way.

MATERIAL AND METHOD :

44 patients of Piles disorder were registered during the course of trial. The study consisted clinical patterns in Piles disorder and the management of the particular conditions with "PIRRHOIDS" tablets.

Out of 32 patients of the trial group, 28 cases had completed the full treatment schedule (i.e., 60 days) and remaining 4 cases had discontinued the course of treatment.

The control group included 12 patients, out of which 10 patients, followed the full term treatment (i.e., 60 days) and rest 2 patient had discontinued the course of treatment.

The clinical pattern were studied in all the 44 cases for incidence of age, sex (male and female) religion, occupation, economic status, educational status, social status and symptoms of piles disorders following routine blood test and stool etc. examination.

SELECTION OF CASES :

All patients selected for study were interrogated and the details history was recorded in the prescribed case history sheet. All patients were thoroughly examined and findings were also recorded. To establish the final diagnosis, the routine examination of blood, Stool and Urine etc. were also done, in addition to the observation of subjective features, clinically.

Criteria for Final Diagnosis :

All the patients included in clinical study were carefully examined physically and records were maintained with detail clinical history. The individual who have symptoms of piles disord ers with or without rectal bleeding were subjected to clinical trial.

METHODS OF DRUG ADMINISTRATION :
 
The drug 11PIRRHOIDS ", was administered orally to the patients of the trial group in the form of tablets prepared and supplied by SHREE BAIDYANATH AYURVED BHAWAN PVT. LTD., 1, Gupta Lane, Kolkata‑700006. The patients of piles disorders taken for the study, were administered 2 tablets twice daily morning and evening with water for a period of 60 days.

'PLACEBO' tablets was administered orally to the patients of control group in the similar way which was also prepared and supplied by the SHREE BAIDYANATH AYURVED BHAWAN PVT. LTD. 1, Gupta Lane, Kolkata‑700006.

DIET :

All the patient selected for trial were advised to avoid spicy foods.

FOLLOW UP :
 
Follow up study was conducted in all the cases at interval of 15 days for 2 months (60 days), Routine blood, stool and Occult blood test were done before treatment and after 2 months (60 days) of treatment.

CLINICAL PATTERN :

The present study consists of total 50 cases who have symptoms of liver disorders and completed the full course
of treatment schedule (i.e., 90 days). But we had registered 55 cases for the present study, out of which 5 cases had not completed the full course of treatment. So the clinical pattern will be discussed on 55 cases. But the result will be analyzed on observation of the findings of 50 cases.

Age Incidents :

Patients of the present study were from 20 to 60 years of age. Patients of different age group are given in Table No. 1.

Table No. 1 : Showing the incidence of different Age Group

Sex Incidence :

Patients of both sexes were registered for the present study. The sex groups are given. in Table No. 2.‑ ..

Table No. 2 : Showing the incidence of Sex

Religion Incidence :

Patients of various religions were included in this study. Patients belonging to different religion are shown in Table No. 3.

Table No. 3 : Showing the incidence of Religion

Occupation Incidence

In this study patients belonging to various occupations were included and shown in Table No. 4.

Table No. 4 : Showing the incidence of Occupation

Economic Status :

In this study patients of different income groups were recorded and shown in Table No. 5.

Table No. 5: Showing the incidence of Income Status

Educational Status :

When educational status was enquired, patients of both literate and illiterate were found in the series. The educational status as found are given in Table No. 6.

Table No. 6 : Showing the Incidence of Educational Status

Rural and Urban Incidence:

This study included patients from urban and rural areas and shown in Table No. 7.

Table No. 7: Showing the Incidence of Rural and Urban

Incidence of Diet Habits :

Patients included in the present study were found to have both types of diet habits
(Vegetarian & Non‑Vegetarian), which are presented in Table No. 8.

Table No. 8 : Showing the incidence of Diet Habits

Incidence of Nature of Work:

In this trial study nature of work were studied which are presented in Table No. 9.

Table No. 9: Showing the Incidence of Nature of Work

Incidence of Marital Status :

In this study married and unmarried both patients are included which are presented in Table No. 10.

Table No. 10 : Showing the Incidence of Marital Status

Incidence of Piles Position

In this study rectum was examined in each individual. It was observed that pile mass was present in different position of the rectum. Our observation is presented below in Table No. 11.

Table No. 11 : Showing the incidence of Position of Piles

Incidence of Rectal Prolapse

In this study rectum was examined in each individual. It was observed that pile mass was present in different position of the rectum. Our observation is presented below in Table No. 12.

Table No. 12 : Showing the incidence of Rectal Prolapse