A COMPARATIVE CLINICAL STUDY OF KSHAR SUTRA AND …

www.wjpps.com Vol 9, Issue 10, 2020.

2532

Singh et al. World Journal of Pharmacy and Pharmaceutical Sciences

A COMPARATIVE CLINICAL STUDY OF GUGGULU-APAMARGA

KSHAR SUTRA AND NIMBA KSHAR SUTRA IN THE MANAGEMENT

OF BHAGANDARA

Dr. Sanjay Kumar Singh*1, Dr. Ajay Kumar Gupta

2 and Dr. Sourmi

3

1P.G Scholar Third Year, P.G. Dept. of Shalya Tantra, Rishikul Campus, Uttarakhand

Ayurved University, Haridwar.

2Professor and Head of Department, P.G Dept. of Shalya Tantra, Rishikul Campus,

Uttarakhand Ayurved University, Haridwar.

3Medical Officer, Rishikul Campus, Uttarakhand Ayurved University, Haridwar.

ABSTRACT

Bhagandara is one of the commonest disease occurring in ano-rectal

region. Bhagandara is progressively increasing in the society due to

apathya sewan, mainly sedentary life style, irregular and inappropriate

diet, prolong sitting, etc. Bhagandara is one among Ashtamahagadas

mentioned by Acharya Sushruta. Bhagandara can be correlated with

Fistula-in-ano in modern science. Management of Fistula-in-ano has

become a challenge to allopathic surgeons due to its complications like

Post-operative pain, wound management, high chance of recurrence,

etc. It is recurrent in nature and due to lack of its complete cure in

modern science, makes it more and more difficult for treatment.

Improper care, poor hygiene and negligence leads to further

aggravation of the disease. Nowdays, management of Bhagandara with Kshar Sutra had

proved as big miraculous revolution, it has gained popularity due to its minimal invasive

approach and complete cure of the disease. It is the demand of time to do further researches

to get more efficient Kshar Sutra. 40 diagnosed cases of Bhagandara were selected from

OPD and IPD of P.G. Department of Shalya Tantra, Rishikul Campus, Uttarakhand Ayurveda

University, Haridwar (U.K.) India. The results showed significant relief in subjective and

objective parameters along with complete cure. Moreover, this therapy was well accepted by

all patients and did not cause any interruption in their daily routine work during period of

management. No complications were observed in this clinical study with follow up period.

WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES

SJIF Impact Factor 7.632

Volume 9, Issue 10, 2532-2549 Research Article ISSN 2278 – 4357

*Corresponding Author

Dr. Sanjay Kumar Singh

P.G Scholar Third Year,

P.G. Dept. of Shalya Tantra,

Rishikul Campus,

Uttarakhand Ayurved

University, Haridwar.

Article Received on

18 August 2020,

Revised on 08 Sept. 2020,

Accepted on 28 Sept. 2020

DOI: 10.20959/wjpps202010-17299


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KEYWORDS: Bhagandara, Fistula-in-ano, Guggulu-Apamarga Kshar Sutra, Nimba Kshar

Sutra.

INTRODUCTION

Ayurveda, the Indian medical science emphasizes on disease prevention than treatment. In

present era busy and sedentary lifestyle along with mental stress and irregular diet schedule

leads to one of the common diseases in ano-rectal region known as Bhagandara (Fistula-in-

ano). According to Sushruta Samhita, Bhagandara is considered under the Astha mahagadas

(eight grave disorders) which are difficult to manage. Bhagandara closely harmonize in

clinical presentation with Fistula-in-ano described in modern medical science.

Cryptoglandular infection, the most common cause, results in ano-rectal abscess and

ultimately leads to Fistula-in-ano. The surgical management of Bhagandara (Fistula-in-ano)

in modern science carries several problems and complications as severe pain for a long period

during, dressing etc. Moreover operative raw site is the potential space for infection by

faeces. Hospitalization and non-ambulatory life for a long period is also a serious problem for

the patient. The disease Fistula in ano still remains a challenge to the science as no specific

surgical method or other medication has proven as complete remedy to cure Fistula in ano.

But in Ayurveda a full-fledged management by Kshar Sutra therapy has been mentioned

since thousand years ago. Acharya Sushruta mentioned Kshar Sutra for the treatment of Nadi

Vran, Bhagandara, Arbud, later on in eleventh century Chakrapanidutt mentioned

preparation of Kshar Sutra and its clear-cut indication in Arsh and Bhagandara in his book

Chakradutt. Kshar Sutra is a medicated alkaline thread. Application of this thread in fistulous

tract allows better wound drainage and simultaneously cutting and healing of the wound. It is

a simple, safe and sure remedy for Bhagandara and is becoming universally acceptable day

by day. Even in modern literature references regarding Kshar Sutra treatment can be seen. In

spite of the fact that the Kshar Sutra, the excellent Ayurvedic remedy has earned an eminency

as the first choice of treatment for fistula-in-ano, the further research on Kshar Sutra is a

demand of time.

AIMS AND OBJECTIVES

1. To evaluate the effect of Guggulu-Apamarga Kshar Sutra in Bhagandara.

2. To evaluate the effect of Nimba Kshar Sutra in Bhagandara.

3. To compare the effect of both these Kshar - Sutras in the treatment of two different

groups of patients of Bhagandara.


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4. To enhance the rate of healing.

5. To decrease the intensity of pain, burning sensation and itching, so that the patient can do

his routine works comfortably.

6. To find out adverse reactions, if any, during the study period.

MATERIAL AND METHODS

The present clinical trial was designed in two groups, on which randomized study was taken

over the patients, suffering from Bhagandara (Fistula in ano).Our Rishikul Hospital

Haridwar has Kshar-Sutra Lab in which preparation of Kshar-Sutra is done under full aseptic

precautions. Patient was examined under Local Anesthesia (Xylocaine jelly 2%) then gentle

probing was done under aseptic conditions. Primary Threading was done with the help of

Surgical linen Barbour Thread No. 20. After that Kshar Sutra was changed weekly after

primary threading by Rail-road technique. This procedure was repeated every week until „cut

through‟ of Kshar Sutra was achieved automatically.

METHOD OF PREPARATION OF KSHAR SUTRA

The technique of preparation of Guggulu-Apamarga Kshar Sutra standardized by the

Department of Shalya Tantra, IMS, Banaras Hindu University, Varanasi (U.P). was followed.

Guggulu-Apamarga Kshar Sutra was prepared by repeated 21 coatings in which 11 coatings

were of Guggulu extract alone, 7 coatings of Guggulu extract with Apamarga Kshar, and 3

coatings of Haridra churna with Guggulu extract were done. Nimba Kshar Sutra was

prepared by repeated 21 coatings in which 11 coatings were of Nimba Putapaka Swaras

alone, 7 coatings of Nimba Putapaka Swaras with Nimba Kshar, and 3 coatings of Haridra

churna with Nimba Putapaka Swaras were done. The prepared Kshar Sutras was packed &

sealed under aseptic precautions and stored in Formalin chamber in operation theatre, and

ready for application in Bhagandara patients.

SELECTION OF PATIENTS

Diagnosed forty cases of Bhagandara (Fistula-in-ano) were registered by simple random

sampling method from OPD and IPD of the Dept. of Shalya Tantra, Rishikul Ayurvedic

college campus hospital Haridwar, Uttarakhand Ayurved University, U.K., INDIA.

SAMPLING TECHNIQUE

A total number of 40 patients of Bhagandara were registered and randomly divided into two

groups, viz.


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Group A – In Group A, Patients (20) were treated with Guggulu-Apamarga Kshar Sutra as

per Classical method.

Group B- In Group B, Patients (20) were treated with Nimba Kshar Sutra as per Classical

method.

CONSENT

The patients seeking the treatment for Bhagandara were selected. They were well informed

about the treatment, and a written informed bilingual consent was obtained from the patient

and patient's close relative.

INCLUSION CRITERIA

Clinical signs and symptoms of all types of Bhagandara; fresh cases as well as previously

operated*.

(*They were operated elsewhere by any other surgeon)

Any age group of either sex.

Bhagandara of all types with Parikartika (Fistula-in-ano with Fissure-in-ano)

Bhagandara with Niyantrita Madhumeha (Fistula-in-ano with controlled Diabetes

mellitus)

Bhagandara with Arsha (Fistula-in-ano with Haemorrrhoid)

EXCLUSION CRITERIA

HIV, HCV and HBsAg positive patients.

Secondary Fistula due to -

-Ulcerative colitis

-Crohn‟s disease

-Tuberculosis

-Carcinoma of rectum

ASSESSMENT CRITERIA

SUBJECTIVE PARAMETERS

Pain (Mild, Moderate, severe & very severe)

Burning sensation (Mild, Moderate, severe & very severe)

Itching (Mild, Moderate, severe & very severe)

Discharge (Mild, Moderate, severe & very severe)


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Inflammation (Mild, Moderate, severe & very severe)

(Very severe++++(4), Severe+++(3), Moderate ++(2), Mild +(1), Absent –(0))

OBJECTIVE PARAMETERS

Unit Cutting Time = Total No. of days taken to cut through the track = days/cm

Initial length of the Kshar Sutra in cm

Efficacy of Kshar Sutra in a group of patients was assessed on the basis of following signs

and symptoms:

Pain

Burning sensation

Itching

Discharge

Inflammation

Unit cutting time (U.C.T.)

GRADING OF ASSESSMENT CRITERIA

1-Pain

Grade Explanation

0 No complain of pain

+ (1) Negligible or tolerable pain. No need of any medicine

++ (2) Localized tolerable pain, completely relieved by hot sitz bath

+++ (3) Intolerable pain, not relieved by hot sitz bath, relieved by oral analgesic.

No disturbance in sleep

++++(4) Continuous and intolerable pain with sleep disturbance. Patient seek

medical help as early as possible

2-Burning sensation

Grade Explanation

0 No complain of any burning sensation

+ (1) Negligible feeling of burning sensation for few minutes in a day

++ (2) Tolerable burning sensation completely relived by hot sitz bath or local oleation

+++ (3) Tolerable but constant burning sensation slightly relieved by hot sitz bath or

local oleation

++++ (4) Unbearable burning sensation which makes the patient to seek feeling of

medical help as soon as possible


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3-Itching

Grade Explanation

0 No complain of itching

+ (1) Negligible itching for few minutes in a day

++ (2) Occasional sensation of itching with 4-6 hrs interval

+++ (3) Frequent sensation of itching with 2-3 hrs interval

++++ (4) Continuous sensation of itching with 15-30 minutes interval

4. Discharge

Grade Explanation

0 No sign of any discharge

+ (1) Occasional appearance of discharge and patient uses single cotton pad in 24 hrs.

++ (2) Frequent appearance of discharge and patient uses 3-4 cotton pads in 24 hrs.

+++ (3) Increased frequency of discharge and patient uses 5-6 cotton pads in 24 hrs.

++++ (4) Continuous discharge

5. Inflammation

Grade Explanation

0 No sign of inflammation around external opening

+ (1) Very little inflammation around external opening

++ (2) Inflammation in 1 cm. diameter of external opening

+++ (3) Inflammation in 2 cm. diameter of external opening

++++ (4) Inflammation in more than 2 cm. diameter of external opening

DURATION OF THE STUDY

It depended on the length of fistulous tract till Kshar Sutra get “cut through” automatically.

FOLLOW UP STUDY

Follow up was done 2 months at every 15 days interval after the completion of treatment.

For each follow-up visit, the patients were examined for any recurrence of disease or any

associated lesion of the ano-rectal region.

RESULT

Effect of therapy on Subjective criteria in 40 patients of Bhagandara:

1. PAIN

Group Mean S.D Difference SE t value P value

GUGGULU APAMARGA KSHARA

SUTRA 0.5 0.22

0 0.05

-14.14 ≤0.05

NIMBA KSHAR SUTRA 0.5 0.22 0.05

Conclusion: As results of GUGGULU APAMARGA KSHARA SUTRA and NIMBA

KSHAR SUTRA both were statistically highly Significant in improving Pain, unpaired t test


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was applied to find which therapy was more efficacious. The difference in the mean values of

the two groups is not greater than would be expected by chance; there is a no statistically

significant difference between the input groups (P value ≤ 0.05).

2. BURNING SENSATION



SUTRA 0.05 0.22

0 0.05

-14.14 ≤0.05



KSHAR SUTRA both were statistically highly Significant in improving Burning Sensation,

unpaired t test was applied to find which therapy was more efficacious. The difference in the

mean values of the two groups is not greater than would be expected by chance; there is a no

statistically significant difference between the input groups (P value ≤ 0.05).

3. ITCHING



SUTRA 0.35 0.48

0.3 0.10

-5.82 ≤0.05



KSHAR SUTRA both were statistically highly Significant in improving Itching, unpaired t

test was applied to find which therapy was more efficacious. The difference in the mean

values of the two groups is not greater than would be expected by chance; there is a no


4. INFLAMMATION


GUGGULU APAMARGA KSHARA SUTRA 0.35 0.48 0.3

0.10 -5.82 ≤0.05



KSHAR SUTRA both were statistically highly Significant in improving Inflammation,

unpaired t test was applied to find which therapy was more efficacious. The difference in the

mean values of the two groups is not greater than would be expected by chance; there is a no



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5. DISCHARGE



SUTRA 0.05 0.22

0 0.05

-14.14 ≤0.05



KSHAR SUTRA both were statistically highly Significant in improving Discharge, unpaired

t test was applied to find which therapy was more efficacious. The difference in the mean

values of the two groups is not greater than would be expected by chance; there is a no


OVERALL RESULT OF U.C.T. ON ALL 40 PATIENTS

S.

No.

Name of

the patients

(Case no.)

Length of

track (in

cm.)

Period of cut

through (approx.

months)

No. of days

taken for cut

through

U.C.T.(in

days/cm)

1 Case no. 1 6.5 cm 2 Months 48 7.38

2 Case no. 2 7.5 cm 2 Months 52 6.9

3 Case no. 3 05 cm 2 Months 59 11.8



6 Case no. 6 6.5 cm 2 Months 53 8.1


8 Case no. 8 05cm 2 Months 45 9.0


10 Case no. 10 5.5 cm 2 Months 49 8.9


12 Case no. 12 7.5 cm 2 Months 54 7.2

13 Case no. 13 8 cm 3 Months 80 10

14 Case no. 14 9.5 cm 3 Months 76 8.0

15 Case no. 15 6.5 cm 2 Months 56 8.6

16 Case no. 16 13 cm 4 Months 102 7.8


18 Case no. 18 05 cm 2 Months 45 9.0

19 Case no. 19 10,10,11 cm 4 Months 114 10.3

20 Case no. 20 9.5 cm 4 Months 97 10.3




24 Case no. 4 10.5 cm 3 Months 95 9..4

25 Case no. 5 7.5 cm 2 Months 62 8.2

26 Case no. 6 5.5 cm 2 Months 54 9.8

27 Case no. 7 6.5 cm 2 Months 62 9.5


29 Case no. 9 11 cm 4 Months 125 11.3


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30 Case no. 10 4.5 cm 2 Months 36 8.2

31 Case no. 11 12 cm 4 Months 109 9.0


33 Case no. 13 13 cm 4Months 112 8.6

34 Case no. 14 14 cm 3 Months 96 6.8

35 Case no. 15 4,13 cm 4 Months 119 7.9

36 Case no. 16 8 cm 3 Months 82 10.5


38 Case no. 18 5.5 cm 2 Months 65 13

39 Case no. 19 06 cm 1 Month 33 5.5

40 Case no. 20 3 cm 2Months 41 8.2

U.C.T. ACCORDING TO TYPES OF FISTULA-IN-ANO

Type of fistula-in-ano U.C.T. (in days / cm.)

Group A Group B

Sub-cutaneous 8.83 9.34

Low anal 8.15 9.07

High anal 8.73 8.63

Mean 8.57 9.01

Group A - In analysis it shows that minimum U.C.T. 8.15 days/cm. in low anal and

maximum U.C.T. 8.83 days/cm. was found in Sub-cutaneous Fistula-in-ano. Mean U.C.T. is

8.57 days/cm.

Group B - In analysis it shows that minimum U.C.T. 8.63 days/cm. in high anal and

maximum U.C.T. 9.34 days/cm. was found in sub-cutaneous Fistula-in-ano. Mean U.C.T. is

9.01 days/cm.

U.C.T. ACCORDING TO TYPES OF BHAGANDARA

Type of Bhagandara U.C.T. (in days / cm.)

Group A Group B

Shataponaka Bhagandara 10.36 7.93

Ushtragreev Bhagandara 8.38 8.72

Parisravi Bhagandara 8.64 9.17

Shambukavarta Bhagandara 8.0 00.00

Unmargi Bhagandara 00.00 00.00

Mean 8.84 8.60

Group A - The above analysis shows that minimum U.C.T. 8.0 day/cm. in Shambukavarta

Bhagandara whereas maximum U.C.T. 10.36 days/cm. was found in Shataponaka

Bhagandara. Mean U.C.T. is 8.84 days/cm.


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Group B - The above analysis shows that minimum U.C.T. 7.93 day/cm. in Shataponaka

Bhagandara whereas maximum U.C.T. 9.17 days/cm. was found in Parisravi Bhagandara.

Mean U.C.T. is 8.60 days/cm.

U.C.T. ACCORDING TO POSITION OF EXTERNAL OPENING

Clockwise position U.C.T. (in days/cm.)

Group A Group B

1 ‘O’Clock 7.6 9.04

2 ‘O’Clock 8.5 9.07

3 ‘O’Clock 8.1 8.09

4 ‘O’Clock 00 10.5

5 ‘O’Clock 9.2 10.6

6 ‘O’Clock 8.8 9.08

7 ‘O’Clock 8.9 8.26

8 ‘O’Clock 00 7.93

9 ‘O’Clock 8.7 00

10 ‘O’Clock 8.6 00

11 ‘O’Clock 9.2 8.35

12 ‘O’Clock 8.2 9.02

Mean 8.5 8.99

Group A -In analysis the study shows that minimum U.C.T. (i.e. 7.6 days/cm.) at 1 „O‟ clock

and maximum U.C.T. (i.e. 9.2 days/cm.) was found at 5 „O‟ and 11 „O‟ clock position. Mean

U.C.T. is 8.5 days/cm.

Group B - In analysis the study shows that minimum U.C.T. (i.e. 7.93 days/cm.) at 8 „O‟

clock and maximum U.C.T. (i.e. 10.6 days/cm.) was found at 5 „O‟ clock position. Mean

U.C.T. is 8.99 days/cm.

U.C.T. ACCORDING TO INITIAL LENGTH OF TRACK

Initial length of track (in cm.) U.C.T. (in days/cm.)

Group A Group B

0 – 5 9.93 8.2

5.1 – 10 8.22 9.2

>10 9.15 8.8

Mean 9.1 8.7

Group A - In analysis it is found that minimum U.C.T. 8.22 days/cm. in group of 5.1-10 cm.

and it was maximum in group of 0-5 cm. i.e. 9.93 days/cm. Mean U.C.T. is 9.1 days/cm.

Group B - In analysis it is found that minimum U.C.T. 8.2 days/cm. in group of 0-5 cm. and

it was maximum in group of 5.1-10 cm. i.e. 9.2 days/cm. Mean U.C.T. is 8.7 days/cm.


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U.C.T. ACCORDING TO CHRONICITY

Chronicity (in years) U.C.T. (in days/cm.)

Group A Group B

0 – 1 8.4 8.7

1 – 2 9.2 10.0

>2 8.5 8.6

Mean 8.7 9.1

Group A -The above study shows that minimum U.C.T. was 8.4 days/cm. under the duration

of 0-1 years, maximum 9.2 days/cm. in 1-2 year. Mean U.C.T. is 8.7 days/cm.

Group B - The above study shows that minimum U.C.T. was 8.7 days/cm. under the duration

of 0-1 years, maximum 10.0 days/cm. in 1-2 year. Mean U.C.T. is 9.1 days/cm.

U.C.T. ACCORDING TO SURGERY

Surgery U.C.T. (in days/ cm.)

Group A Group B

Operated 8.86 8.94

Non –operated 9.13 8.98

Mean 8.9 8.96

Group A -In analysis table shows that U.C.T. was 8.86 days/cm. in operated cases and 9.13

days/cm. in non-operated cases. Mean U.C.T. is 8.9 days/cm.

Group B -In analysis table shows that U.C.T. was 8.94 days/cm. in operated cases and 8.98

days/cm. in non-operated cases. Mean U.C.T. is 8.96 days/cm.

U.C.T. ACCORDING TO TRACT OF FISTULA-IN-ANO

Type of track U.C.T. (in days/ cm.)

Group A Group B

Curved 9.28 8.7

Straight 7.66 9.1

Mean 8.47 8.9

Group A -The above table shows that minimum U.C.T. 7.66 days/cm. in Straight track and

maximum U.C.T. 9.28 days/cm. in Curved track. Mean U.C.T. is 8.47 days/cm.

Group B -The above table shows that minimum U.C.T. 8.7 days/cm. in curved track and

maximum U.C.T. 9.1 days/cm. in straight track. Mean U.C.T. is 8.9 days/cm.


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COMPARATIVE EFFECTS OF TREATMENT (MEAN) ON INDIVIDUAL

SYMPTOMS

Sr. no Signs and

symptoms

Mean Score

Group A Group B

B.T. AT B.T. AT

1 Itching 2.9 0.35 2.8 0.05

2 Pain 2.9 0.05 1.4 0.33

3 Discharge 3.3 0.05 1.4 0.33

4 Burning Sensation 1.8 0.05 1.4 0.33

5 Inflammation 2.1 0.35 2.2 0.05

COMPARATIVE EFFECT OF TREATMENT (% EFFECT) ON INDIVIDUAL

SYMPTOMS

Sr. no. Signs and

symptoms

Percentage of Relief (%)

Group A Group B

1 Itching 89.17% 98.33%

2 Pain 98.33% 98.75%

3 Discharge 97.50% 97.50%

4 Burning Sensation 97.50% 97.50%

5 Inflammation 84.17% 98.33%

ESTIMATION OF OVERALL RESULT IN 40 PATIENTS

Final result Anarogya

(unchanged)

Kinchit-arogya

(improved) Arogya (cured)

After 1 month 30 09 1

After 2 months 08 11 21

After 3 months 0 08 32

After completion of therapy 0 0 40

RESULT OF THERAPY

Result of therapy No. of patients Percentage

Arogya (Cured) 40 100%

Anarogya (Unchanged) 0 0%

DISCUSSION

Fistula-in-ano was recognized as disease known as Bhagandara since the time of Acharya

Sushruta and since then it was included among the list of Ashtamahagada (eight grave

diseases). Then also, it was difficult to treat. In modern science no satisfactory answer is

obtained regarding about the management of Bhagandara (Fistula-in-ano). In the whole

scenario, it was Prof. P.J. Deshpandey at Banaras Hindu University, Department of Shalya

Tantra, who took the lead after pristine Acharya for exploring the technique, brought back the

usefulness of Kshar Sutra for Nadivrana and Bhagandara and improved and standardized it


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with the help of modern science and technology and certified that the Kshar Sutra

management is a safe, effective and unhazardous method of treatment for Fistula-in-ano.

Kshar Sutra has emerged as an impressive curative modality to replace the regular surgical

procedures in the management of Bhagandara with negligible rate of recurrence and

complication in comparison to the synchronous methods like fistulectomy, fistulotomy and

many more, but not a single method is safer and better than Kshar Sutra management. A

number of clinical trials have proven this fact. Total 40 patients were taken and treated with

Guggulu-Apamarga Kshar Sutra and Nimba Kshar Sutra. It was found that maximum

number of patients (50%) were between the age group 35-50 years, male patients was

obtained higher (92.50%) than female (7.50%) and in occupation, service class patients

(50%) were registered more. This study also shows that maximum cases have given the

history of constipation (47.5%) and in most of cases external openings were found at 6

o‟clock position with a percentage of 21.47%.

DISCUSSION ON SUBJECTIVE PARAMETERS

PAIN

Group A - In this study before treatment Pain was present in all 20 patients and after

completion of treatment Pain subsided in all patients completely. Thus Pain got cured in

98.33% of patients. On statistical observation p-value < 0.05, it means that the overall

therapy is significant to cure Pain in the patients of Bhagandara. This is probably due to

Ushna Virya and Vedena –sthapana karma of the contents of Guggulu-Apamarga Kshar

Sutra. Pharmacological analgesic action of Guggulu-Apamarga Kshar Sutra is attributed to

Oleoresin and Flavonoids of Guggulu, and Saponins and Glycosides of Apamarga.

Group B - In this study, before treatment Pain was present in all 20 patients and after

completion of treatment Pain was subsided in all Patients completely. Thus Pain got cured in

98.75% of patients. On Statistical observation p-value < 0.05, it means that the overall

therapy is significant to cure Pain in the patients of Bhagandara. In Dhanvantari Nighantu it

is emphasized that Nimba has a property which does help in suppuration of immature shotha

and drains the suppurated Vrana, this lead to cleaning of the cavity, subsequently subsides the

pain. Analgesic properties of Nimba Kshar Sutra, which causes relief in pain of Bhagandara

patients was due to Leaf Extract of Nimba and Ethanolic extract of Haridra.


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BURNING SENSATION

Group A - Before treatment, Burning Sensation was present in all 20 patients and after

completion of treatment Burning Sensation cured in 97.5% patients of Bhagandara. It is

statistically Significant with p-value < 0.05. The predictable reason for decrease of burning

sensation may be the Tikta Rasa and Dahprashaman Karma of the contents of Guggulu-

Apamarga Kshar Sutra. Pharmocological Burning sensation relieving effect due to Oleoresin,

Flavanoids and β-Sitosterol of Guggulu, and Glycosides, Curcumine, Curumenone,

Comphor, Eugeonal of Haridra.

Group B - Before treatment, Burning Sensation was present in all 20 patients and after

completion of treatment Burning Sensation cured in 97.5% patients of Bhagandara. It is

statistically Significant with p-value < 0.05. Nimba Kshar Sutra has a good Pitta-shamak

property due to having Tikta, Kashaya Rasa and Sheeta Virya, so that it reduces the Burning

sensation. Nimba Kshar Sutra shows significant result in Burning sensation relieving effect

due to Nimbidin of Nimba and Glycosides, Curcumine, Curumenone, Comphor, Eugeonal of

Haridra.

ITCHING

Group A - Before treatment Itching was present in all 20 patients and after completion of

treatment Itching cured in 89.17% patients. On Statistical observation, p-value < 0.05, it

means that the overall therapy is significant to cure Itching in the patients of Bhagandara.

This is probably due to Katu, Tikta, Kashaya Rasa; Ushna Virya; Katu Vipaka and

Kandughna as well as Krimighna properties of the contents of Guggulu-Apamarga Kshar

Sutra. Presence of flavonoids and Oleoresin of Guggulu and minerals like Phosphorus and

Potassium in Apamarga, also shows anti-pruritic effect.

Group B - Before treatment, Itching was present in all 20 patients and after completion of

treatment Itching cured in 98.33% patients. On Statistical observation p-value < 0.05, it

means that the overall therapy is significant to cure Itching in the patients of Bhagandara.

This is probably due to Tikta, Kashaya Rasa; Sheeta Virya; Katu Vipaka and Kandughna as

well as Krimighna properties of the contents of Nimba Kshar Sutra. The Presence of

Azadirachtin, Salannin, Meliantriol, and Nimbin of Nimba and curcumin of Haridra, shows

anti-pruritic effect.


2546


DISCHARGE

Group A - Before treatment, Discharge was present in all 20 patients and after completion of

treatment Discharge was eliminated in all 20 patients i.e. 97.5% cured. On Statistical

observation p value < 0.05, it means that the overall therapy is significant to cure Discharge

in the patients of Bhagandara. This is probably due to Katu, Tikta, Kashaya Rasa; Ushna

Virya; Katu Vipaka and Vrana-Shodhana, Vrana-Ropana, Shothahara properties of the

contents of Guggulu-Apamarga Kshar Sutra. The anti-microbial and anti-bacterial action of

Flavonoids, Essential oil and β Sitosterol of Guggulu, eliminated discharge significantly. The

Antibacterial property of leaf of Apamarga also helped in reducing the Discharge.

Group B - Before treatment, Discharge was present in all 20 patients and after completion of

treatment Discharge was eliminated in all 20 patients i.e. 97.5% cured. On Statistical

observation p value < 0.05, it means that the overall therapy is significant to cure Discharge

in the patients of Bhagandara. This is probably due to Tikta, Kashaya Rasa; Sheet Virya;

Katu Vipaka and Vrana-Shodhana, Vrana-Ropana properties of the contents of Nimba Kshar

Sutra. Due to anti-bacterial action of Haridra and Flavonoid, Tannins, Saponins of Nimba,

discharge was eliminated significantly.

INFLAMMATION

Group A - Before treatment, Inflammation was present in all 20 patients and after

completion of treatment Inflammation cured in 100% patients of Bhagandara. It is

statistically Significant with p-value < 0.05. Most of the contents of Guggulu Apamarga

Kshar Sutra are Kashaya-Tikta Rasa Pradhana, with Katu Vipaka and have Vrana-

Shodhana, Vrana-Ropan, Shothahara properties. Guggulu-Apamarga Kshar Sutra shows

significant effect in curing Inflammation due to its constituents, viz. as follows –Flavonoids,

Oleoresin, Guggulsterone, Curcumine, Curumenone, Comphor, Eugeonal and

Epiprocurcumenol.

Group B - Before treatment, Inflammation was present in all 20 patients and after

completion of treatment Inflammation cured in 100% patients of Bhagandara. It is

statistically Significant with p-value < 0.05. Most of the contents of Nimba Kshar Sutra are

Kashaya-Tikta Rasa Pradhan, with Katu Vipaka and have Vrana-Shodhana, Vrana-Ropan

properties. Moreover, the Flavonoids, Tannins, Saponins of Nimba shows Anti-inflammatory

action.


2547


COMPARISION BETWEEN GROUP A AND GROUP B

For comparison between Group A and Group B, we have used Unpaired t-Test. P-Values for

all parameters are less than 0.05. Hence, it is concluded that there is significant difference

between Group A and Group B.

It was observed that subjective parameter Pain had more relief (98.75%) in group B, as

compared to group A (98.33%).

It was observed that subjective parameter Burning sensation had similer relief (97.50%)

in both groups.

It was observed that subjective parameter Itching had more relief (98.33%) in group B, as

compared to group A (89.17%).

It was observed that subjective parameter Discharge had similer relief (97.50%) in both

groups.

It was observed that subjective parameter inflammation had more relief (98.33%) in

group B, as compared to group A (84.17%).

It was observed that objective parameter U.C.T. was less in group A (8.62 days/cm) as

compared to group B (8.97 days/cm).

OVERALL EFFECT OF THE THERAPY

Total 40 patients were treated in this present study out of which 100% were Cured

Completely

In both treatment groups none of the patients remained unchanged / uncured.

In none case, any sign and symptom of the recurrence & incontinence was ever found out

during study period or follow up.

During the course of study and post-treatment follow-up, no adverse reaction of any drugs

/ procedure was observed.

CONCLUSION

In modern surgery so many forms of treatment for Bhagandara (Fistula-in-ano) shows its

limitations and complications. Not a single treatment is spanking for Bhagandara (Fistula-in-

ano) till today. In modern science people are still looking for new modalities for Fistula-in-

ano but there is no answer regarding its complications such as frequent recurrences, faecal

soiling and imperfect control of flatus, chronic wound healing, long hospitalization etc. Kshar

Sutra management is popular as non-recurrence treatment for Fistula-in-ano. Kshar and other

herbs is applied to exhibit both, mechanical and chemical effect which promote in cutting and


2548


healing of the Fistula track. Guggulu-Apamarga Kshar Sutra (Group A) and Nimba Kshar

Sutra (Group B), both effectively cured all the Bhagandara (Fistula in ano) patients.

Guggulu Apamarga Kshar Sutra has shown good results, particularly for less U.C.T., in

previous operated cases of Bhagandara. Nimba Kshar Sutra has shown better results due to

its various properties specially reduction in inflammation and subsiding itching. In all

subjective and objective parameters, it is observed that Group-B is more effective than

Group-A. The Preparation of Kshar Sutra using Nimba Kshar may open a new path in the

treatment of Bhagandara. Keeping this in mind, clinical study was tried and many positive

hopes were observed. Nimba Kshar Sutra possess various properties like Vranashodhan,

Vranaropan, etc. which helps in early healing. In statistical analysis Nimba Kshar Sutra

therapy showed significant results. Guggulu-Apamarga Kshar Sutra and Nimba Kshar Sutra

can be advised as a successful treatment modality in patients of Bhagandara.

REFERENCES

1. Acharya Sushruta, Sushruta Samhita;Ayurveda - Tattva - Sandipika Hindi commentary;

Edited by Kaviraja Ambikadutta Shastri; Chaukhambha Sanskrit Sansthan, Varanasi,

Edition; Reprint 2012; Sutra Sthaana- 15/ 48, page no.84.

2. SRB‟s MANUAL OF SURGERY by Sriram Bhat M Jaypee Brothers Medical Publishers

(P) Ltd New Delhi 110002, India 4rth edition Chapter no. 25 RECTUM and ANAL

CANAL page no. 1055.

3. Jhongoligher and Harold Nixon, Surgery of Anus, rectum and colon vol.I 5th ed.

A.I.T.B.S. Publisher Krishna nagar Delhi, Fistula in ano chapter 7, page-178.

4. Acharya Sushruta, Sushruta Samhita; Ayurveda - Tattva - Sandipika Hindi commentary;


Edition; Reprint 2012; Cikitsa Sthaana -17/32, page no.101.

5. Dr Indradeva Tripathi, Vaidayaprabha, Hindi Commentary on Chakradutt, by Sri

Chakrapanidatta, Chapter- Arshodhikar, Edition: Reprint, Chaukhambha Bharati

Academy, Varanasi, 2012. p. 66.

6. Deshpande, P.J., Pathak, S.N., Rao, I.S. and Shankaran, P.S.: A review of 40 cases of

fistula - in - ano treated with Kshara Sutra "Nagrjuna- Dec. 1977; 4: 160-171.

7. Acharya Sushruta, Sushruta Samhita; Ayurveda-Tattva-Sandipika Hindi commentary;


Edition: Reprint 2010; Nidan Sthaana – 4 page no.316,317,318.

8. S. Das A Concise text book of surgery 8th edition chapter no. 45 page no.1073.


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9. Guggulu: An Herbal Preparation with many health-giving uses, By Dr.Micheal Tiera,

O.M.D. October 2008.

10. Indian journal of natural products and resourses, june 2012; 3(32): 281-284. Invitro

evaluation of antibacterial activity of crude extracts of Achyranthes aspera.

11. Journal homepage: www.elsevier.com/locate/jopr. Review article: Evaluation of

Phytochemical and Pharmacological aspects of Azadirachta indica.

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A COMPARATIVE CLINICAL STUDY OF KSHAR SUTRA AND …