E-ISSN:2456-3110

Research Article

Fistula-In-Ano

Journal of Ayurveda and Integrated Medical Sciences

2023 Volume 8 Number 12 December
Publisherwww.maharshicharaka.in

A randomized open labelled controlled clinical study to evaluate the role of Krutamalakadya Sutra in the management of Bhagandara with special reference to Fistula-In-Ano

Kumar J N1*, Muralidhara N2, Sweta K3
DOI:10.21760/jaims.8.12.7

1* Naveen Kumar J, Post Graduate Scholar, Department of Shalya Tantra, Sri Sri College of Ayurvedic Science and Research Hospital, Bengaluru, Karnataka, India.

2 Muralidhara N, Professor, Department of Shalya Tantra, Sri Sri College of Ayurvedic Science and Research Hospital, Bengaluru, Karnataka, India.

3 KM Sweta, Professor HOD, Department of Shalya Tantra, Sri Sri College of Ayurvedic Science and Research Hospital, Bengaluru, Karnataka, India.

Acharya Sushruta has included Bhagandara as one among the Ashtamahagadas. Fistula in ano is an ano-rectal condition with a worldwide prevalence of 8.6 cases per 100,000 population. Ksharasutra ligation is one of the popular modalities in treatment of Bhagandara. In present era, there are different types of Ksharasutra available. Most widely used Ksharasutra is Apamarga Ksharasutra which is having Chedana, Bhedana, Lekhana properties and anti-inflammatory effect on the fistula tract. But some of the problems are faced during preparation and also in the course of Ksharasutra therapy viz, collection and preservation of Snuhi (Euphorbia nerifolia) latex is very difficult and time taking process. The main complaints reported by the patients are pain and discomfort during the course of treatment with Ksharasutra for Bhagandara, which requires management with oral analgesics. Considering the above problems, a non irritant preparation such as Krutamalakadya Varti mentioned in Sushruta Samhita in the chapter of Bhagandara Chikitsa Adhyaya is modified in the form of Krutamalakadya Sutra which contains following ingredients such as Aragvadha, Haridra, Ahimsra, Madhu and Ghrita is taken for the study. Krutamalakadya Sutra is also having a good binding property, as well as Chedana, Bhedana, Lekhana, Vedanasthapana, Vrana Shodhana and Vrana Ropana properties. A total of 30 subjects were taken, Trial group treated with Krutamalakadya Sutra and control group treated with Apamarga Ksharasutra. The study shows that preparation of Krutamalakadya Sutra is much easier than Apamarga Ksharasutra and had high efficacy in subjective parameters like burning sensation compared to Apamarga Ksharasutra.

Keywords: Krutamalakadya Sutra; Apamarga Ksharasutra; Bhagandara; Fistula in ano.

Corresponding Author How to Cite this Article To Browse
Naveen Kumar J, Post Graduate Scholar, Department of Shalya Tantra, Sri Sri College of Ayurvedic Science and Research Hospital, Bengaluru, Karnataka, India.
Email:
Kumar J N, Muralidhara N, Sweta K, A randomized open labelled controlled clinical study to evaluate the role of Krutamalakadya Sutra in the management of Bhagandara with special reference to Fistula-In-Ano. J Ayu Int Med Sci. 2023;8(12):42-53.
Available From
https://jaims.in/jaims/article/view/2955

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2023-10-09 2023-10-16 2023-10-21 2023-10-31 2023-11-18
Conflict of Interest Funding Ethical Approval Plagiarism X-checker Note
Nil Non Funded. Yes 21.98%

© 2023by Kumar J N, Muralidhara N, Sweta Kand Published by Maharshi Charaka Ayurveda Organization. This is an Open Access article licensed under a Creative Commons Attribution 4.0 International License https://creativecommons.org/licenses/by/4.0/ unported [CC BY 4.0].

Introduction

Acharya Sushruta counted Bhagandara among the Ashtamahagadas,[1] which are difficult to cure. Acharya Sushruta has described different therapeutic measures for the management of Bhagandara as in

terms of various oral medications, local applications, surgical procedures and para - surgical intervention. Presently Ksharasutra therapy is found most approaching and attractive treatment modality among para-surgical procedures for fistula in ano. It is a standard treatment modality found in surgical practice for the management of fistula in ano. Most widely used is Apamarga Ksharasutra which is having Chedana, Bhedana, Lekhana properties and anti-inflammatory effect on fistula tract.[2] But some of the problems are faced during preparation and also in the course of Ksharasutra therapy viz, collection and preservation of Snuhi (Euphorbia nerifolia) latex is very difficult and time taking process. Kshara does not permit to prepare in humid climate. The main complaints reported by the patients are pain and discomfort during the course of treatment with Ksharasutra for Bhagandara, which requires management with oral analgesics.

Considering the above problems, a non irritant preparation such as Krutamalakadya Varti mentioned in Sushruta Samhita in the chapter of Bhagandara Chikitsa Adhyaya is modified in the form of Krutamalakadya Sutra which contains following ingredients such as Aragvadha, Haridra, Ahimsra, Madhu and Ghrita is taken for the study.[3]

Krutamalakadya Sutra is also having a good binding property, as well as Chedana, Bhedana, Lekhana, Vedanasthapana, Vrana Shodhana and Vrana Ropana properties.[4]

Aim

To evaluate the role of Krutamalakadya Sutra in the management of Bhagandara w.s.r. to Fistula in ano.

Objectives of the study

1. To evaluate the role of Krutamalakadya Sutra in the management of fistula-in-ano.
2. To re-evaluate the role of Apamarga Ksharasutra in the management of fistula-in-ano.
3. To compare the role of Krutamalakadya Sutra with Apamarga Ksharasutra in the management of fistula-in-ano.

Materials And Methods

The study design was open label, randomized controlled clinical study, in this study 30 patients who fulfilled the inclusion criteria were selected from OPD, IPD department of Shalya Tantra. They were divided into two groups Group A (N=15) and Group B (N=15). Group A being the control group and Group B being the trial group. IEC approval was taken before starting the Trial, informed written consent of all patients was taken before the operative procedure. Duration of treatment was 4 weeks.

Preparation of Krutamalakadya Sutra

Materials Required

1. Aragvadha (Phala Majja) (fig. 1)
2. Ahimsra (Root) (fig. 2)
3. Haridra (Rhizome) (fig. 3)
4. Madhu (fig. 4)
5. Thread (Barbour’s linen no .20) (fig. 5)
6. Ghrita (fig. 6)
7. Ksharasutra cabinet


Figure 1: Aragvadha (Phala Majja)


Figure 2: Ahimsra (Root)



Figure 3: Haridra Choorna


Figure 4: Madhu


Figure 5: Barbour’s linen no. 20


Figure 6: Ghrita


Figure 7: Paste of drugs


Figure 8: Thread coating with medicated paste


Figure 9: Krutamalakadya Sutra

Preparation

1. Krutamalakadya Sutra were prepared by using Barbour’s thread number 20.
2. Linen thread were tied throughout the length of the hanger, which were then mounted over hanger stand. Each thread on the hanger were uniformly smeared with mixture of Aragvadha Phala Majja, Ahimsra root powder, Haridra powder, Madhu and Ghrita which was taken in equal quantity. The hanger were replaced into to the cabinet. The cabinet was closed properly and the hot air was blown in order to dry the threads. Same process were repeated till it attain standard diameter of 1.9mm of Apamarga Ksharasutra.
3. Krutamalakadya Sutra was sterilized by ultraviolet radiation by placing them in Ksharasutra cabinet for 20-30 minute at 40 0C.


4. Sterilized Krutamalakadya Sutra measuring approximately 10 inches was cut away at two ends and packed in sterilized glass tubes by aseptic precaution. (fig no-9)
5. It took 5 days to achieve a thickness of 1.9 millimeters and complete the preparation

Poovakarma

1. Well informed written consent was taken prior to the procedure.
2. Xylocaine Sensitivity test (SC) and Tetanus Toxoid (IM) given prior to procedure.
3. Perianal Part Preparation was done.
4. Laxatives (Triphala Churna) were given prior to procedure

Pradhana Karma

Group A:

Application of Apamarga Ksharasutra Patient was taken into lithotomy position and cleaning and draping was done. The appropriate anesthesia was used. The patient was assured and gloved finger was gently introduced into the rectum. Then a suitable probe was passed through the external opening of fistula. The tip of the probe was forwarded along the path of least resistance being guided by the finger in rectum to reach into the lumen of anal canal through the internal opening and its tip was finally directed to come out of anal orifice. Primary thread was taken and threaded into the eye of probe, thereafter the probe was pulled out through the anal orifice to leave the thread behind in the fistulous track. The two ends of the thread were then tied together with a moderate tightness outside the anal canal.

Group B:

Application of Krutamalakadya Sutra Patient was taken into lithotomy position and cleaning and draping done. The appropriate anesthesia was used. The patient was assured and gloved finger was gently introduced into the rectum. Then a suitable probe was passed through the external opening of fistula. The tip of the probe was forwarded along the path of least resistance being guided by the finger in rectum to reach into the lumen of anal canal through the internal opening and its tip was finally directed to come out of anal orifice. Primary thread was taken and threaded into the eye of probe, thereafter the probe was pulled out through the anal orifice to leave the thread behind

in the fistulous track. The two ends of the thread were then tied together with a moderate tightness outside the anal canal.

Paschat Karma

After Application of Ksharasutra

1. Tab. Triphala Guggulu 2 bid before food for 4 weeks
2. Tab. Gandhaka Rasayana 2 bid after food for 4 weeks
3. Patient were asked to do sitz bath with Panchavalkala Kashaya twice daily from post op day 1.
4. Regular dressing was done.

Thread change

In both the groups Ksharasutra was changed once in a week. i.e., on 7th day, 14th day, 21st day and 28th day.

Diagnostic Criteria

Subjects with classical features of Bhagandara (Fistula-in-ano) were selected for study such as Pidaka associated with Ruk, Kandu, Daha, Srava and Shopha around perianal region.

Inclusion Criteria

1. Subjects within the age of 21-60 years.
2. Subjects irrespective of gender, religion, occupation, economic status and education status.
3. Subjects with well controlled Diabetes Mellitus and hypertension.

Exclusion Criteria

1. Fistula-in-ano caused secondary to or associated with diseases like- Tuberculosis, Crohn’s disease, Ulcerative colitis, Osteomyelitis, Venereal diseases, HIV, Appendicitis, Regional Ileitis and Intestinal & Pelvic Malignancies.
2. Fistula-in-ano associated with other anorectal disorders such as Carcinoma rectum and anal canal, 3rd degree Hemorrhoids or bleeding hemorrhoids, acute fissure in ano, thrombosed sentinel pile.

Assessment Criteria

(A) Subjective Parameter

1. Assessment of pain
2. Assessment of burning sensation




(B) Objective Parameter

1. UCT - Unit Cutting Time calculation.
2. Assessment of discharge
3. Length of the tract
4. Local Tenderness

Grading of the Parameters

1. Visual Analogue Scale (VAS) for Pain Assessment.[5]
2.Burning Sensation.[6]

  • Grade 0 - No burning sensation
  • Grade 1 - Mild burning sensation
  • Grade 2 - Moderate burning sensation
  • Grade 3 - Severe burning sensation.

3. UCT- Unit Cutting Time.[7]

UCT=(Initial length of the tract – length of the tract remaining)/(Number of weeks treated)

4. [8]

  • Grade 0: No discharge
  • Grade 1: Mild discharge
  • Grade 2: Moderate discharge
  • Grade 3: Profuse discharge

5. Length of the tract [9]

  • Grade 0: No tract
  • Grade 1: Up to 1 cm
  • Grade 2: 1.1cm - 2cm
  • Grade 3: 2.1cm - 3cm
  • Grade 4: 3.1cm - 4cm
  • Grade 5: 4.1cm - 5cm
  • Grade 6: More than 5cm

6. Local Tenderness[9]

  • Grade 0 - No Tenderness
  • Grade 1 - Tenderness to palpation, without grimace or flinch
  • Grade 2 - Tenderness with grimace and/ or flinch to palpation
  • Grade 3 - Tenderness with withdrawal “jump sign”
  • Grade 4 - Withdrawal “jump sign” to non- noxious stimuli (i.e., superficial palpation, pin prick, gentle percussion).

Observations

Observation during preparation and intervention

Group A - Apamarga Ksharsutra

1. Collection and preservation of Snuhi Ksheera and Apamarga is a laborious and hazardous process.
2. Apamarga Panchanga burnt quickly and easily as it was completely dried. Comparatively, seeds took more time to burn.
3. The resulting ash from burning the Panchanga was whitish in color and possessed a characteristic taste
4. After proper filtration, boiling, and drying, a whitish Kshara substance was obtained.
5. Sutra was evenly coated with a mixture of Snuhi Ksheera, Apamarga Kshara, and Haridra.
6. The preparation of Ksharasutra is a meticulous process. It took 21 days to complete 21 coatings.
7. During the procedure of thread change subjects experienced more pain and discomfort.

Group B - Krutamalakadya Sutra

1. The accessibility of Aragvada fruit simplifies the sourcing process for its usage in the preparation of Sutra.
2. Phala Majja readily dissolves in water.
3. During the dissolution process, a pleasant and sweet aroma is released, enhancing the sensory experience.
4. The severe allergic conjunctival reactions were noted during the process of boiling the mixture to evaporate water, thus effective safety measures were taken.
5. A paste was prepared by combining Aragvada Phala Majja, Ahimsra root powder, Haridra, Madhu and Ghrita. The binding nature of the ingredients allows for the even spreading of the paste on the thread.
6. The Sutra, when treated with the aforementioned drug, undergoes rapid drying, resulting in a quick attainment of approximately 1.9mm thickness within a short period of 5 days.
7. During the procedure of thread change subjects experienced less pain and discomfort.

@P<0.05 in comparison to D0 value (Friedman’s test)

*P=0.012 In Comparison to Group A values (Mann whitney rank sum test)


**P=0.033 In Comparison to Group A values (Mann whitney rank sum test)

Table 1: Assessment of pain by Friedman’s test and Mann whitney rank sum test

GroupPain assessment at different points of time (Data: Median, 25th & 75th Percentile)
0 Day7th day14th day21th day28th day
Group-A Control3.00(3.00-3.00)3.00(3.00-3.00)2.00(2.00-2.00)@2.00(1.00-2.00)@1.00
(1.00-1.00)@
Group-B Trial3.00(3.00-3.00)2.00(2.00-3.00)*2.00(1.00-2.00)@1.00(1.00-2.00)@**1.00
(1.00-1.00)@

Table 2: Assessment of Burning sensation by Friedman’s test and Mann whitney rank sum test

GroupBurning sensation assessment at different points of time (Data: Median, 25th & 75th Percentile)
0 Day7th day14th day21th day28th day
Group-A Control3.00(3.00-3.00)3.00(2.00-3.00)2.00(2.00-2.00)@2.00(1.00-2.00)@1.00
(1.00-2.00)@
Group-B Trial3.00(3.00-3.00)2.00(2.00-3.00)**2.00(1.00-2.00)@1.00(1.00-1.00)@*1.00
(0.00-1.00)@

@P<0.05 in comparison to D0 values (Friedman’s test)

*P=0.001 In Comparison to Group A values (Mann whitney rank sum test)

**P=0.03 In Comparison to Group A values (Mann whitney rank sum test)

Table 3: Assessment of Discharge by Friedman’s test and Mann whitney rank sum test

Day of assessment0 Day7th day14th day21th day28th day
Group-A Control3.00(3.00-3.00)3.00(3.00-3.00)2.00(2.00-2.00)@2.00(1.00-1.00)@1.00
(1.00-1.00)@
Group-B Trial3.00(3.00-3.00)2.00(2.00-2.00)*1.00(1.00-2.00)@**1.00(1.00-1.00)@*1.00
(0.00-1.00)@

@P<0.05 in comparison to D0 value(Fried man’s test)

*P=0.001 in comparison to Group A value (Mann whitney rank sum test)

**P=0.024 in comparison to Group A value (Mann whitney rank sum test)

Table 4: Assessment of length of the tract by Friedman’s test and Mann whitney rank sum test

GroupLength of the tract assessment at different points of time (Data: Median, 25th & 75th Percentile)
0 Day7th day14th day21th day28th day
Group-A Control4.00(3.00-4.00)4.00(3.00-4.00)3.00(2.00-4.00)2.00(2.00-3.00)@1.00
(1.00-1.00)@
Group-B Trial5.00(4.00-6.00)4.00(3.00-5.00)3.00(3.00-4.00)2.00(2.00-3.00)@1.00
(1.00-2.00)@

@P<0.05 in comparison to D0 value((Friedman’s test)

Table 5: Assessment of local tenderness by Friedman’s test and Mann whitney rank sum test

GroupLocal tenderness assessment at different points of time (Data: Median, 25th & 75th Percentile)
0 Day7th day14th day21th day28th day
Group-A Control4.00(4.00-4.00)4.00(3.00-4.00)3.00(2.00-3.00)@2.00(2.00-2.00)@2.00
(1.00-2.00)@
Group-B Trial4.00(4.00-4.00)3.00(3.00-3.00)2.00(2.00-3.00)@*2.00(1.00-2.00)@**1.00
(1.00-1.00)@***

@P<0.05 in comparison to D0 valve((Friedman’s test)

*p=0.028 in comparison to Group A valve (Mann whitney rank sum test)

**p=0.019 in comparison to Group A valve (Mann whitney rank sum test)

***p=0.002 in comparison to Group A valve (Mann whitney rank sum test)

Results

The comprehensive analysis of all the results reveals that both the intervention produced significant results but Group-B delivered better out come over Group-A (Table 6)

Table 6: Summary of statistical results

ParameterWithin the GroupBetween the Groups
Group-AGroup-B
PainSignificantSignificantGroup B had significant reduction over Group A
Burning sensationSignificantSignificantGroup B had significant reduction over Group A
DischargeSignificantSignificantGroup B had significant reduction over Group A
UCTNo-SignificantNo-SignificantNo significant difference between the groups
Length of the tractNo-SignificantNo-SignificantNo significant difference between the groups
Local tendernessSignificantSignificantGroup B had significant reduction over Group A

Trial group




Day 0


Day 7



Day 14


Day 21


Day 28

Control group


Day 0



Day 7


Day 14


Day 21


Day 28

Analytical results of Krutamalakadya Sutra

Physio-chemical analysis was done at Ramaiha Advanced Laboratory, Bengaluru and Microbiological studies were done at Krishna Diagnostic Laboratory, Sagara. Which showed fallowing results:

SNParameterResultsTest Method
1.Ph (10% solution)10.1Physio-chemical method
2.Thickness (mm)1.9
3.Length (cm)10
4.Tensile strength (kg)5.8

Microbiology

TestReport
Culture and sensitivitySample has showed no microbial growth after 48 hours of incubation

Limitations

  1. The entire procedure of preparation of Krutamalakadi Sutra caused severe irritation to the conjunctiva.
  2. Regulation of the temperature required for Paaka depending on the source of drug is still to be standardised as boiling even for a longer duration leads to Khara Paaka in some sources of same drug.
  3. The study duration was of short period, sample size was limited to 30 subjects in this study.

Discussion

In the present clinical study 15 cases were treated with Apamarga Ksharasutra and 15 cases were treated with Krutamalakadya Sutra The observations were made on different parameters like pain, Burning sensation, Unit Cutting Time, Length of tract, Discharge and Local tenderness

Pain


In Group-A Significant decrease in pain was observed on D14, D21 and D28. whereas, in Group-B Significant decrease in pain was observed on D7, D14, D21 and D28. Thus statistically, the scores for pain obtained in Group-B (P=0.001) is much better than Group-A (P=0.005)

The effect size difference of pain between Group A and Group B was small band on the 28th day. This suggests that Group B experienced a better clinical benefit from pain than Group A. When mean score percentage was calculated, it found that Group-A had 66.66% and Group-B had 64.43% reduction of pain. However, Group-B showed Significant decrease in pain during course of treatment.

The reduced pain experienced during the treatment is attributed to the Vedanasthapana and Vranasodhana properties of Aragvadha,[17] Ahimsra[18] and Haridra.[19] These drugs contain beneficial compounds such as Anthraquinones, alkaloids, flavonoids, saponins, tannins, polyphenols, and curcumin. The combined effects of these medicinal properties alleviate pain and promote the healing process. which is achieved through the drug action in Krutamalakadya Sutra.

Burning sensation

In Group-A Significant decrease in burning sensation was observed on D14, D21 and D28. whereas, in Group-B Significant decrease in burning sensation was observed on D7, D14, D21 and D28.Thus statistically, the scores for burning sensation obtained in Group-B (P=0.001) is much better than Group-A (P=0.05).

The difference in burning sensation relief between and within the two group was also evident in effect size analysis, which showed that Group-B experienced a marked reduction in burning sensation during the course of treatment. The mean score percentage analysis revealed that Group-B experienced 66.66% greater burning sensation relief than Group-A 54.55%.

As Ahimsra which possesses the Tiktha Rasa, along with Kruthamala, Madhu,[20] and Ghritha,[21] which have Sheeta Veerya, which contribute to the alleviation of burning sensation during the treatment. Due to presence flavonoids and polyphenols in Madhu and Kruthamalaka, which exhibit anti-inflammatory properties and helps in reducing the burning sensation.

Moisturization and cooling effect of Madhu, and Ghritha, attributes to relieve burning sensation.

Discharge

In Group-A Significant decrease in discharge was observed on D14, D21 and D28. Whereas, in Group-B Significant decrease in discharge was observed on D7, D14, D21 and D28. Thus statistically, the scores for discharge obtained in Group-B (P=0.024) is much better than Group-A (P=0.05).

The effect size analysis revealed a significant decrease in discharge between and within two groups, it suggests that Group-B experienced a better clinical benefit from decrease in discharge over the course of treatment. According to mean score percentage analysis Group-B had 75.55% decrease in discharge more effective than Group-A 66.66%.

Krutamalakadya Sutra possesses Vrana Shodhana, and Vrana Ropana properties. This can show beyond doubt by anti-inflammatory and antimicrobial properties of drug i.e., Kruthamala, Ahimsra and Haridra which helps to decrease the microbial load, there by promoting and sloughing and fasting the healing process.

Unit Cutting Time

In this study, the average Unit Cutting Time (UCT) was utilized as a standardized measure to evaluate the efficacy of Krutamalakadya Sutra and Apamarga Ksharasutra in cutting and healing of fistulous tracks.

The average UCT recorded for Krutamalakadya Sutra was 0.8cm/7 days, while for Apamarga Ksharasutra it was 0.7cm/7 days.

Statistical analysis revealed that there was no significant difference observed in UCT between the groups. Furthermore, within each group, no significant differences in UCT were found.

These findings indicate that both Krutamalakadya Sutra and Apamarga Ksharasutra exhibited equal efficacy in terms of the rate of healing of the fistulous tracks, as evidenced by the similar UCT values obtained.

Therefore, based on the UCT assessment, it can be concluded that there was no significant difference in the healing effectiveness between the two treatment groups, suggesting that both Krutamalakadya Sutra


and Apamarga Ksharasutra are viable therapeutic options for the management of fistulous tracks . But there is mild clinical difference seen.

Length of the tract

In Group-A Significant decrease in length of the tract was observed on D14, D21 and D28. Whereas in Group-B Significant decrease in length of the tract was observed on D7, D14, D21 and D28.

These findings highlight the effectiveness of both treatment modalities in reducing the length of fistulous tracts. However, Group-B demonstrated a more pronounced and consistent response, with significant decreases observed at all time points.

The effect size difference of length of the tract between Group A and Group B was not much significant.

When mean score percentage was calculated. It is found that Group-A had 72.40% and Group-B had 70.00% decrease in length.

Kshara Sutra works by pressure necrosis, chemical cauterization by Kshara and sloughing of the fistula track tissue along with adequate drainage. It leads to an easy debridement of unhealthy tissue and pus and thus providing a cleaner base for the wound healing of the fistulous track.

Local tenderness

In Group-A Significant decrease in local tenderness was observed on D14, and D21. Whereas in Group-B Significant decrease in pain was observed on D7, D14, D21 and D28. Thus, statistically the scores for local tenderness obtained in Group-B is much better than Group-A.

The effect size difference of local tenderness between groups and within groups is large band. This suggests that Group-B experienced a better clinical benefit from local tenderness than Group-A. When mean score percentage is calculated. It is found Group-B had 74.14% reduction of local tenderness than Group-A 59.31%.

The properties of Aragvadha, Ahimsra, and Haridra are attributed to their Vedanasthapana and Vranasodhana effects. These drugs possess antioxidant, antimicrobial, and anti-inflammatory properties due to the presence of alkaloids, Anthraquinones, flavonoids, saponins, tannins, polyphenols, and curcumin. These beneficial

effects help to reduce inflammation and local tenderness during treatment. Overall, the drugs' action in Krutamalakadya Sutra contributes to the reduction of local tenderness.

Conclusion

Krutamalakadya Sutra demonstrated significant efficacy in relieving symptoms associated with fistula-in-ano, including pain, burning sensation, discharge, and local tenderness. Moreover, it achieved these outcomes in a shorter duration of time. Evaluation of subjective and objective parameters indicated that Krutamalakadya Sutra exhibited superior clinical relief compared to Apamarga Ksharasutra in most aspects. Krutamalakadya Sutra was cost-effective treatment options, as they could be easily prepared and applied as compared to Apamarga Ksharasutra. The statistical analysis supported to rejected null hypothesis and accepted alternative hypothesis, indicating that Krutamalakadya Sutra is having more efficacy than Apamarga Ksharasutra in the management of Bhagandara with special reference to Fistula-in-ano.

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