Post marketing Clinical evaluation of “The Dependable...

Post marketing Clinical evaluation of “The Dependable & Safe Laxative” –

“ANULOMA - Churna” in pre & post-operative cases. The present observational study was conducted at “Shri Jayachamarajendra Institute of Indian

Medicine, Bangalore” Under the chief observation of Dr.Shivu Arakeri M.S (Ayu) and assistance

of Dr.Aravinda Shenoy. A (M.S) {Ayu}. INTRODUCTION: “Anuloma churna” is a quality product from “Sagar pharmaceuticals” which is highly

regarded by practitioners and has been marketed for 44 years. It is a unique formulation which

provides quick and safe relief from constipation. Present observational study was conducted to assess the effectiveness of “Anuloma churna”

when used for laxative action in pre & post operative patients suffering from ano-rectal

disorders. Material & Methods – method of collection of data: The present study was a observational study which involved recording of various parameters

and feedbacks from the patients after therapy with “Anuloma churna” was initiated. The improvements in following various parameters were assessed:

1. Bowel frequency: This was studied in the view that an ideal laxative should clear constipation but should not result in increased bowel frequency. The criterion for grading was as follows: Grade 3 –

4+/day. Grade 2

– 3/day Grade 1 –

2/day Grade 0 –

1/day.

2. Bowel consistency: This was another important criterion which was assessed in the view

of assessing the consistency for being as close to normalcy. Excess fluid loss from the

body may lead to other complications like dehydration. Thus an ideal & safe laxative should evacuate the stools but should not cause dehydration. The criterion for grading was as follows: Grade 3 – Too

fluid Grade 2 –

Watery Grade 1 –

Loose Grade 0 –

3. Degree of straining: if there is more straining during defecation, may lead to

complications in ano-rectal disorders. Also straining for defecation has been understood

as a well known cause for hemorrhoids. The criterion for grading was as follows: Grade 3 – Severe

Grade 2 –

Moderate Grade 1

– Mild Grade 0 –

Absent

4. Feeling of incomplete evacuation: The subjective symptom of incomplete bowel

evacuation may disrupt psychological state of the patient. The criterion for grading was as follows: Grade 3 – Severe

Grade 2 –

Moderate Grade 1


Absent

5. Impact on quality of life: The most common complaint among patients of ano-rectal

disorders. This can disrupt the patient’s daily routine as well as compromise his/her

psychological state, thus this was assessed. This parameter gives a direct indication for the effectiveness of the medicine. The criterion for grading was as follows: Grade 3 – Uneasiness throughout the day.

Grade 2 – Uneasiness at times in a day.

Grade 1 – Uneasiness only during defecation

Grade 0 – No complaints 6. Loss of appetite: Commonly found in patients of Ano-rectal disorders. The improvement

in the appetite was thus assessed. {Ayurveda postulates - impaired “Agni” (Digestive

fire) is the root cause for all ano-rectal disorders.} The criterion for grading was as follows: Grade 3 – Severe

Grade 2 –

Moderate Grade 1


Absent.

Results: Table 1: Age distribution of patients studied:

Per

cen

t

ages

Age in years Number of patients %

21-30 13 28.3

31-40 9 19.6

41-50 14 30.4

51-60 8 17.4

61-70 2 4.3

Total 46 100.0

Mean ± SD:

40.98±11.19

50

45

40

28.3

30.4

35

30

19.6

25

17.4

20

15

10 4.3

5

0

21-30 31-40 41-50 51-60 61-70

Age in

years

Table 2: Gender distribution of patients studied

Gender Number of patients %

Male 37 90.4

Female 9 9.6

Total 46 100.0

PARAMETER ASSESSMENT RESULTS:

1. Bowel frequency: Table 3: An evaluation of effectiveness of Anuloma Churna based on Bowel frequency:

Time

Bowel frequency(n=46)

Mean ± SD P value

points

1/day

2/day

3/day 4/day

Day 1 4(8.7%) 18(39.1%) 24(52.2%) 0(0%) 1.43±0.66 -

Day 2 10(21.7%) 22(47.8%) 14(30.4%) 0(0%) 1.09±0.73 <0.001**

Day 3 13(28.3%) 30(65.2%) 3(6.5%) 0(0%) 0.78±0.55 <0.001**

Day 4 23(50%) 22(47.8%) 1(2.2%) 0(0%) 0.52±0.55 <0.001**

Day 5 29(63%) 16(34.8%) 1(2.2%) 0(0%) 0.39±0.54 <0.001**

• Results suggest bowel frequency returning to normalcy with continued therapy.

Per

cen

tag

es

100

90

80

70

60

50

40 Bowel

frequency

30

1/day

2/da

y

20

10

3/day

4/da

y

0

Day 1 Day 2 Day 3 Day 4 Day 5

Time points

Post marketing Clinical evaluation of “The Dependable & Safe Laxative” – “ANULOMA -

Churna” in pre & post operative cases.

2. Bowel consistency: Table 4: An evaluation of effectiveness of Anuloma Churna based on Bowel

consistency:

Time

Bowel consistency

(n=46)

Mean ± SD P value

points

Soft

Loose Watery Too fluid

Day 1 3(6.5%) 25(54.3%) 17(37%) 1(2.2%) 1.35±0.64 -

Day 2 6(13%) 34(73.9%) 6(13%) 0(0%) 1.00±0.52 0.001**

Day 3 14(30.4%) 29(63%) 3(6.5%) 0(0%) 0.76±0.56 <0.001**

Day 4 25(54.3%) 18(39.1%) 3(6.5%) 0(0%) 0.52±0.62 <0.001**

Day 5 29(63%) 15(32.6%) 2(4.3%) 0(0%) 0.41±0.58 <0.001**

• Results suggest that the therapy resulted in return of bowel consistency towards soft, as

at the end ot the study 63% of the patients were in this group.

Per

cen

tag

es

100

90

80

70

60

50

40 Bowel

frequency

30 Soft

20

Loose

Watery

10

Too fluid

0


T

i

m

e

p

o

i

n

t

s



3. Degree of straining: Table 5: An evaluation of effectiveness of Anuloma Churna based on Degree of

straining

Time

Degree of straining

(n=46)

Mean ± SD P value

points

Absent

Mild Moderate Severe

Day 1 10(21.7%) 23(50%) 10(21.7%) 3(6.5%) 1.13±0.83 -

Day 2 15(32.6%) 22(47.8%) 8(17.4%) 1(2.2%) 0.89±0.77 0.002**

Day 3 23(50%) 18(39.1%) 5(10.9%) 0(0%) 0.61±0.69 <0.001**

Day 4 30(65.2%) 13(28.3%) 3(6.5%) 0(0%) 0.41±0.62 <0.001**

Day 5 38(82.6%) 8(17.4%) 0(0%) 0(0%) 0.17±0.38 <0.001**

• Results suggest “Anuloma churna” achieved laxation and smooth evacuation of bowels

without the patients having to strain for defecation.

Per

cen

tag

es

100

90

80

70

60

50

40 Degree of

straining

30 Absent

20

Mild

Moderate

10

Severe

0


T

i

m

e

p

o

i

n

t

s



4. Feeling of incomplete evacuation: Table 6: An evaluation of effectiveness of Anuloma Churna based on Feeling of

incomplete bowel movement

Time

Feeling of incomplete bowel movement

(n=46)

Mean ± SD P value

points

Absent

Mild Moderate Severe

Day 1 5(10.9%) 14(30.4%) 25(54.3%) 2(4.3%) 1.52±0.75 -

Day 2 15(32.6%) 16(34.8%) 14(30.4%) 1(2.2%) 1.02±0.86 <0.001**

Day 3 21(45.7%) 18(39.1%) 7(15.2%) 0(0%) 0.70±0.73 <0.001**

Day 4 30(65.2%) 11(23.9%) 5(10.9%) 0(0%) 0.46±0.69 <0.001**

Day 5 34(73.9%) 9(19.6%) 3(6.5%) 0(0%) 0.33±0.59 <0.001**

• The subjective feeling of incomplete bowel evacuation in patients was relieved with

statistically significant results.

Per

cen

tag

es

100

90

80

70

60

50 Feeling of

incomplete

40

bowel

movement

30 Absent

20

Mild

Moderate

10

Severe

0


T

i

m

e

p

o

i

n

t

s



5. Impact on quality of life: Table 7: An evaluation of effectiveness of Anuloma Churna based on Impact on quality

of life

Impact on quality of life

(n=46)

Time

Mean ± SD P value

Uneasiness Uneasiness

Uneasines

s

points No

only during at times in a

througho

ut

complaint

s

defecation day

the day

Day 1 0(0%) 12(26.1%) 9(19.6%) 25(54.3%) 2.28±0.86 -

Day 2 1(2.2%) 13(28.3%) 13(28.3%) 19(41.3%) 2.09±0.89 0.007**

Day 3 5(10.9%) 14(30.4%) 21(45.7%) 6(13%) 1.61±0.86 <0.001**

Day 4 10(21.7%) 16(34.8%) 20(43.5%) 0(0%) 1.22±0.78 <0.001**

Day 5 17(37%) 17(37%) 12(26.1%) 0(0%) 0.89±0.79 <0.001**

• Results suggest more number of patients improved quality of life with therapy of

“Anuloma churna” • Note: pain was a significant criteria in this assessment parameter as patients on post-

operative care were more prone to continuous pain.

Per

cen

tag

es

100 Impact on quality of life

90

No

complaints

80

Uneasiness only during

defecation

Uneasiness at times in a

day

70 Uneasiness throughout the

day

60

50

40

30

20

10

0


T

i

m

e

p

o

i

n

t

s



6. Loss of appetite: Table 8: An evaluation of effectiveness of Anuloma Churna based on Impact on Loss of

appetite

Time

Impact on quality of life

(n=46)

Mean ± SD P value

points

Absent

Mild Moderate

Severe

Day 1 2(4.3%) 18(39.1%) 23(50%) 3(6.5%) 1.59±0.68 -

Day 2 11(23.9%) 25(54.3%) 8(17.4%) 2(4.3%) 1.02±0.77 <0.001**

Day 3 26(56.5%) 14(30.4%) 6(13%) 0(0%) 0.57±0.72 <0.001**

Day 4 31(67.4%) 12(26.1%) 3(6.5%) 0(0%) 0.39±0.61 <0.001**

Day 5 39(84.8%) 6(13%) 2(4.3%) 0(0%) 0.20±0.50 <0.001**

• “Anuloma churna” improved appetite in patients on therapy, the results

were statistically highly significant.

Per

cen

tag

es

100

90

80

70

60

50 Impact on

quality life

40

30

Absent

20

Mild

Moderate

10 Severe

0

D

a

y 1 Day 2 Day 3 Day 4 Day 5

Time points Significant figures + Suggestive significance (P value:

0.05<P<0.10) * Moderately significant ( P value:0.01<P ≤

0.05) ** Strongly significant (P value : P≤0.01).


Churna” in pre & post operative cases. OVERALL RESULT:

Result

11%

2%

Excellent

30%

57%

Good

Satisfacto

ry

Poor

60

50

40

30

No. of

Patients

20

%

10

0

Excellent Good Satisfactory Poor



Statistical Methods: Descriptive and inferential statistical analysis has been carried out in

the present study. Results on continuous measurements are presented on Mean ± SD (Min-Max) and results on categorical

measurements are presented in Number (%). Significance is assessed at 5 % level of

significance . The following assumptions on data is made, Assumptions: 1.Dependent variables

should be normally distributed, 2.Samples drawn from the population should be random, Cases

of the samples should be independent

Non-paramteric Wilcoxon Signed rank test has been used to find the significance of score

from baseline. Conclusion: The above study proves the effectiveness of “ANULOMA CHURNA” in management of

Constipation and also especially in patients of Pre and Post operative cases where patients are

immobilized.

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