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Clinical Trial Report of PIRRHOIDS TABLETS In Piles Disorder

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

S1. No.

Age Group (years)

No. of Patients

Percentage

1.

20-35

15-14

31.82

2.

36-50

24

54.55

3.

51 and above

06

13.63

 

Total

44

100

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

S1. No.

Sex

No. of Patients

Percentage

I .

Male

34

77.27

2.

Female

10

22.73

Total

44

100

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

S1. No.

Sex

No. of Patients

Percentage

1.

Muslim

30

68.18

2.

Hindu

10

22.73

3.

Christian

04

9.09

Total

44

100

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

S1. No.

Occupation

No. of Patients

Percentage

1.

Service

10

22.72

2.

House wives

05

11.37

3.

Labour

07

15.90

4.

Businessman

10

22.72

5.

Student

05

11.37

6.

Cultivator

04

9.10

7.

Retired

03

6.82

Total

44

100

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

SI. No.

Income Status

No. of Patients

Percentage

I .

L.I.G.

26

59.09

2.

M.I.G.

18

40.91

Total

44

100

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

SI. No.

Educational Status

No. of Patients

Percentage

1.

Illiterate

4

09.10

2.

Primary

15

34.10

3.

Madhyarnik

05

11.36

4.

Higher Secondary

07

15.90

5.

Graduate

10

22.72

6.

Post Graduate

03

06.82

Total

44

100

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

SI. No.

Rural / Urban

No. of Patients

Percentage

1.

Rural

14

31.82

2.

Urban

30

68.18

Total

44

100

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

SI. No.

Diet Habits

No. of Patients

Percentage

1.

Non Vegetarian

35

79.54

2.

Vegetarian

09

20.46

Total

44

100

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

SI. No.

Nature of Work

No. of Patients

Percentage

1.

Sedentary

26

59.10

2.

Moderate

11

25.00

3.

Hardworker

07

15.90

Total

44

100

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

SI. No.

Marital Status

No. of Patients

Percentage

I .

Unmarried

06

13.64

2.

Married

38

86.36

Total

44

100

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

S1. No.

Position of Piles

No. of Patients

Percentage

1.

3 O'Clock

16

36.37

2.

5 O'Clock

14

31.81

3.

7 O'Clock

18

40.91

4.

9 O'Clock

30

68.18

5.

11 O'Clock

36

81.82

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

S1. No.

Rectal Prolapse

No. of Patients

Percentage

1.

Rectal Prolapse with piles

10

27.73

2.

Piles without Rectal Prolapse

34

77.27

Total

44

100

Incidence of Rectal Bleeding :

In this series the status of rectal bleeding was observed in each in~ividual by interogation and oral examination. The observation is presented below in Table No. 13.

Table No. 13 : Showing the status of bleeding in Patients of Piles

S1. No.

Bleeding Status

No. of Patients

Percentage

1.

None bleeding Piles

10

22.73

2.

Bleeding Piles

34

77.27

 

A. Active bleeding

12

35.29

 

B. Non Active bleeding

22

64.71

RESULT AND OBSERVATION:

Response of Treatment in Group A (Trial Group)

Group-A or Trial group consisted of 32 patients, out of which 4 patients had discontinued and 28 cases had completed the treatment schedule of 60 days. Patients were observed in terms of subjective criterias before treatment, during treatment and after treatment. The response of treatment on subjective criterias as observed before treatment and after treatment are presented below in Table No. 14.

Table No. 14 : Showing the response of treatment on subjective features of piles disorders in trial group (group A, N=28)

Sr. No.

Symptoms

No. of Patients B.T.

No. of Patients relieved A.T.

Percentage of Relief

1.

Pain in Rectum

21

18

85.71

2.

Bleeding P/R

25

24

96.00

3.

Rectal pruritus

28

20

71.42

4.

Rectal prolapse

10

4

40.00

5.

Constipation

28

22

78.58

6.

Heaviness of abdomen

24

17

70.84

7.

Flatulence

26

19

73.08

8.

Vertigo

21

15

71.42

9.

Loss of Weight

18

10

55.56

10.

Weakness

27

18

66.67

11.

Rectal growth

15

11

73.33

It is revealed from the above table that more than 70% of relief was observed in symptoms like pain in rectum, Rectal pruritus, constipation, flatulence and vertigo. More than 60% of relief was observed in symptoms like rectal bleeding, discharge of pus and mucous and weakness. Less than 60% relief was found in other symptoms.

Response of treatment In Group 1111 (Control Group)

Group B or Control Group consisted of 12 patients out of which 2 patients had discontinued the treatment and 10 patients had completed the treatment schedule of 60 days. Patients were observed in terms of subjective features (as in trial group A) before treatment, during treatment and after treatment. The response of the treatment on subjective criteries as observed before the treatment and after the treatment are presented below in table no. 15.

Table No. 15 : Showing the response of treatment on subjective features of piles disorders in Control group (group B, N=10)

Sr.No.

Symptoms

No. of Patients B.T.

No. of Patients relieved A.T.

Percentage of Relief

1 .

Pain in Rectum

9

9

0.00

2.

Bleeding P/R

6

6

0.00

3.

Rectal pruritus

7

8

-14.28

4.

Rectal prolapse

4

4

0.00

5.

Constipation

9

9

0.00

6.

Heaviness of abdomen

10

10

0.00

7.

Flatulence

8

9

-12.5

8.

Vertigo

6

8

-33.33

9.

Loss of Weight

9

9

0.00

10.

Weakness

8

9

-12.5

11.

Rectal growth

5

5

0.00

The responses of treatment on subjective features in patients of Group B (control group) as revealed from the above table, it is found that there was no relief in subjective features. Moreover, negative relief, was observed in some of the subjective features like rectal pruritus, flatulence, vertigo and weakness.

DISCUSSION:

In the present clinical study 44 patients suffering from Arsha or Haemorrboids disorders were included . The total cases were randomly divided into two groups viz. (1) Group A (Trial Group) consisted of 32 patients to whom PIRRHOIDS, the trial drug was given for a period of 60 days, (2) Group B (Control Group) consisted of 12 cases to whom placebo was given for period of 60 days. Out of these cases 4 cases could not be followed in Group A (Trial Group) and 2 cases in Group B (Control Group), 28 cases in Group A (Trial Group) and 10 cases in Group B (Control Group) could be followed up properly.

In trial group, to all the patients "PIRRHOIDS " tablets was given in the dose of 2 tablets twice daily orally, morning and evening with water for a period of 60 days. Similarly in Control Group, to all the cases 'PLACEBO' tablets was given in the dose of 2 tablets twice daily morning and evening with water.

The effect of treatment on both the group of patients were assessed at the end of the treatment. The response of the treatment was observed mainly on subjective improvements. At the end of the treatment, the result was assessed in terms of excellent improvement, good improvement and poor improvement. The patients were included under excellent response group when they showed more than 70% relief of subjective features. The patients were included under good response group when they showed more than 50*10 relief of subjective features and patients showing relief of subjective features below 50% were leveled under poor response group. In consideration to the effects of the drug in Trial Group 28.57% cases were included tinder excellent response group, 53.57% under good response groups and 17.86% under poor response group.

In the trial group in most of the cases subjective features was found to be reduced. The effects of the treatment on subjective features in patients of group A (Trial Group) have been analyzed and found highly significant. Any improvement in patients of Control Group (Group B) was not found when the effect of the treatment on subjective criteria's were analyzed.



CONCLUSION :

The drug "PIRRHOIDS " tablets has been found to be an effective drug is piles disorders. The result in the trial group has shown encouraging results after 4 weeks of treatment. After 60 days of treatment along with the improvements of the subjective criteria's significant response was also noticed. The active bleeding was found to be controlled by two weeks and there was prompt response in constipation, pain in rectum, and rectal pruritus. in any cases, the size of the piles mass was found reduced. Hence 'PIRRHOIDS' can safely be prescribed in bleeding /non bleeding haernorrhoids.