E-ISSN:2456-3110

Research Article

Katupila Arka

Journal of Ayurveda and Integrated Medical Sciences

2022 Volume 7 Number 6 July
Publisherwww.maharshicharaka.in

A clinical trial to evaluate the efficacy of Katupila Arka in post-operative fistulotomy wound

Lakshmi R.1*, Sweta K.2, Surendranath D.3
DOI: http://dx.doi.org/10.21760/jaims.7.6.4

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

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

3 Dhyan Surendranath, Associate Professor, Department of Shalya Tantra, Sri Sri College of Ayurvedic Science and Research Hospital, Bengaluru, Karnataka, India.

Post-operative fistulotomy wound is a surgically created wound for the better healing of fistulous tract. It is considered as the standard treatment modality for fistula in ano and is the most widely performed procedure. The healing of the fistulotomy wound is a challenging task as the chances of infection is more because of its contaminated nature. This can be related to Vrana in Ayurveda and can be managed. There is a need for drugs which have Vrana Shodhaka and Vrana Ropaka properties. Katupila (Securinega leucopyrus (Wild.) Muell) has all the above said properties due to the presence of various phytochemical agents. It’s having a broad spectrum anti-microbial activity. References from a previous work done on Katupila Kalka indicate that, it is effective for the management of diabetic wound. Keeping the practical difficulty in the preparation of Kalka on daily basis, Arka Kalpana is adopted as an alternate method here. Katupila Arka showed marked ulcer regression during the course of treatment than Povidone Iodine which could be attributed to Vrana Shodana and Ropana property. It renders Shodhana (Cleansing/ Purification) action by virtue of its Kashaya and Tikta Rasas, Laghu, Ruksha, Tikshna Gunas, Ushna Veerya and Katu Vipaka. Ropana (Tissue healing / Regeneration) by virtue of its Kashaya and Madhura Anurasa and overall, by Prabhava. Tannins, Flavonoids, Phenol, Saponins and Alkaloids are present in the trial drug which enhances the wound healing property.

Keywords: Vrana Sodhana, Vrana Ropana, Katupila, Seccurinega leucopyrus, Arka

Corresponding Author How to Cite this Article To Browse
R Lakshmi, Post Graduate Scholar, Department of Shalya Tantra, Sri Sri College of Ayurvedic Science and Research Hospital, Bengaluru, Karnataka, India.
Email: 		R Lakshmi, KM Sweta, Dhyan Surendranath, A clinical trial to evaluate the efficacy of Katupila Arka in post-operative fistulotomy wound. J Ayu Int Med Sci. 2022;7(6):23-27.
Available From
https://jaims.in/jaims/article/view/1943

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2022-05-23 2022-05-24 2022-05-31 2022-06-07 2022-06-14
Conflict of Interest Funding Ethical Approval Plagiarism X-checker Note
Nil Nil Yes 19%

© 2022by R Lakshmi, KM Sweta, Dhyan Surendranathand 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].

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Lakshmi R et al: Efficacy of Katupila Arka in post-operative fistulotomy wound

Introduction

Post-operative fistulotomy wound is a surgically created wound for the better healing of fistulous tract. Fistulotomy is considered as the standard treatment modality for fistula in ano and is the most widely performed procedure about an average of 55.6% cases.[1] It is the classic method, where the track of the fistula being laid widely open and the resulting wound is allowed to heal by granulation. Fistulotomy has a complete healing rate over 90% of low inter-sphincteric and Trans sphincteric fistula.[2]

The wound is more prone to contamination due to its anatomical position and the less resting period. This can be related to Vrana in Ayurveda.[3] Acharya Susrutha has quoted Vrana in an elaborate manner, from his keen observations. He has proposed Sixty Upakramas for the management of Vrana. Major emphasis is given for the essentiality of adopting the principle of Vrana Shodana and Vrana Ropana. So, a drug which possess Vrana Shodhana and Vrana Ropana property is needed for the better management.[4]

Katupila (Seccurinega leucopyrus (Wild.) Muell) is a folklore medicine widely used in Sri Lanka for the management of acute, chronic and non-healing wounds. Katupila extract have a broad spectrum anti-microbial activity. The pharmacognostic study of Katupila shows the presence of tannins, calcium oxalate and other essential oils which promote wound healing. References from a previous work done on Katupila Kalka indicate that, it is effective for the management of diabetic wound.[5]

Keeping the practical difficulty in the preparation of Kalka on daily basis, Arka Kalpana is adopted as an alternate method here.[6] Arka is a liquid preparation obtained by distillation of certain liquids or drugs soaked in water using the Arkayantra or any convenient modern distillation apparatus.[7] The increased potency, easy absorption and applicability make it special. And even can be expected to have a better result as the drug possess active principles in it.

Povidone-iodine have remained popular after decades of use for antisepsis and wound healing property. Its broad spectrum of activity, ability to penetrate biofilms, lack of associated resistance, anti-inflammatory, good tolerability has been cited as important factor and no negative

effect on wound healing. It’s expected to remain a highly effective treatment for acute and chronic wound.[8]

Katupila Arka is taken as a trial drug as it possesses an antimicrobial action along with its inherent property to directly facilitate wound healing process. Thus, analyse and evaluate the efficacy of drug in post-operative fistulotomy wound.

Materials and Methods

Preparation of Katupila Arka

Ingredients: Katupila (stem course powder) - 200ml

Water - 2000ml

Procedure: Katupila is taken and made into course powder. 200ml (66gm) of the drug is taken and soaked in 10 parts of water i.e., 2000ml and it’s kept for a day. Then it was transferred into distillation apparatus with condenser attached to it and closed properly.

Temperature was maintained at 60° throughout the procedure. Arka started draining out of the receiver after 45 to 50 minutes. The collected Arka was stored in amber air tight glass bottle. About 800 ml is collected in 7 hours.

Research design and study population

Thirty subjects who were diagnosed with post-operative fistulotomy wound were selected fulfilling the inclusion criteria from Out Patient and In Patients of department of Shalya tantra, SSCAS&RH, Bengaluru and were randomly distributed into 2 groups of 15 each using simple randomization method (lottery method).

During the course of treatment, subjects from both the group were allowed to continue with their regular medications which did not interfere with the study.

Diagnostic criteria: Subject who underwent fistulotomy were taken for the study.

Inclusion criteria

  • Subjects who have a post-operative fistulotomy wound were included in the study.
  • Subjects of either gender.
  • Subjects whose age was in between 21-60.
  • Subjects who fulfilled the diagnostic criteria.

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Lakshmi R et al: Efficacy of Katupila Arka in post-operative fistulotomy wound

Exclusion criteria

  • Wounds other than fistulotomy wound were excluded from the study.
  • Subjects with signs and symptoms of septicemia.
  • Subjects diagnosed with HIV, HbsAg, leprosy, tuberculosis, malignancy.
  • Subjects suffering from nephrotic syndrome, auto immune disorders.

Intervention

Group A (Control Group)

Fifteen subjects of group A were allotted for dressing with sterile gauze soaked in Povidone-iodine twice daily for fourteen days.

Group B (Trial Group)

Fifteen subjects of group B were allotted for dressing with sterile gauze soaked in Katupila Arka twice daily for fourteen days.

Assessment Criteria: Subjective parameters which include pain and burning sensation, pain was assessed in Visual Analog Scale and burning sensation by grading from 0 to 3. Objective parameter was assessed by Bates Jensen Wound Assessment tool.[9] It serves to assess the progression of wound healing.

Duration of study

  • Total duration of study was 28 days.
  • Duration of treatment - 14 days (observations were made on 0th, 7th, 14th day).
  • Follow up period - 14 days.

Observation and Results

Observation during intervention

  • Both Povidone iodine and Katupila Arka were easy to apply.
  • Katupila Arka was non-irritant; But povidone iodine caused mild irritation.
  • Protected the ulcer from further damage.
  • Maintained adequate moisture.
  • Promoted exude drainage.
  • No signs of infection manifested during intervention.

Results

Table 1: Between the group comparison (BT) and (AT) for Pain

Assessment of Pain 0th day 7th day 14th day 28th day (follow up) p value
Group A   5.67 ± 0.55 4.80 ± 0.55 4.07 ± 0.53 3.00 ± 0.53 ** P 0.019 ***p 0.005  
Group B   6.13 ± 0.40 4.47 ± 0.46 2.53 ± 0.41** 1.00 ± 0.35***

Table 2: Between the group comparison (BT) and (AT) for Burning Sensation

Assessment of Burning Sensation 0th day 7th day 14th day 28th day (follow up) p value
Group A 2.40 ± 0.19 2.13 ± 0.19 2.13 ± 0.19 1.53 ±  0.17   **p<0.007  
Group B 2.60 ± 0.13 2.13 ± 0.13 1.60 ± 0.13 0.80 ± 0.11**

Table 3: Between the group comparison (BT) and (AT) for BWAT

Assessment of BWAT 0th day 7th day 14th day 28th day (follow up) p value
Group A 2.33 ± 0.25   2.27 ± 0.27   2.20 ± 0.28   2.00 ± 0.24   **p<0.023  
Group B 2.27 ± 0.18 1.93 ± 0.18 1.60± 0.19 1.20 ± 0.11**

Total duration of the study was 28 days including follow up. Assessment was made on 0th, 7th, 14th, 28th day. On assessment of pain, it was found a significant reduction observed on 14th day and 28th day in Group B (trial group) compared to Group A (control group). In burning sensation also, the p value is significant in Group B compared to Group A.

In the total assessment of wound was done with Bates-Jensen Wound Assessment Tool Score, there was highly significant decrease (p<0.023) was observed in Group B in comparison to Group A i.e., remarkable improvement in wound regression in Group B.

Discussion

There was significant difference in pain between the groups (p value<0.05), within the group. Group B showed marked reduction in pain during the course of treatment unlike Group A, which could be due to the presence of Alkaloids, Flavonoids, Saponins, Tannins and can be ascribed as the Vatahara effect of the drug (Snigdha, Guru-Guna).


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Lakshmi R et al: Efficacy of Katupila Arka in post-operative fistulotomy wound

In terms of burning sensation, significant reduction in burning sensation in Group B may be due to Pittahara and Kashaya Rasa properties which can be attributed as the Dahasamana property of Katupila.

Ulcer regression was observed in Group A was due to the antimicrobial and anti-inflammatory action of povidone iodine. Whereas Group B has showed marked ulcer regression during the course of treatment than Group A, which could be attributed to Vrana Shodana and Ropana property. It renders Shodhana (Cleansing/ Purification) action by virtue of its Kashaya and Tikta Rasas, Laghu, Ruksha, Tikshna Gunas, Ushna Veerya and Katu Vipaka.

Ropana (Tissue healing / Regeneration) by virtue of its Kashaya and Madhura Anu-Rasa and overall, by Prabhava.[10]

Tannins, Flavonoids, Phenol, Saponins, Alkaloids are present in the Katupila Arka which enhances the wound healing property by virtue of its antioxidant, anti-inflammatory, antimicrobial property and the direct effect of tannins and flavanoids in promoting healing process by wound contraction with increased capillary formation and fibroblast proliferation, followed by enhanced rate of epithelialization.[11-13]

Control Group


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Limitation

Undermining, surrounding skin colour change, peripheral tissue oedema and induration criteria of BWAT was inessential as it is not the characteristic feature of post-operative fistulotomy wound. Hence, insignificant results in both the groups.

Conclusion

Fistulotomy is the surgical procedure, where the fistulous tract being laid widely open and the resulting wound is allowed to heal by granulation. In this clinical trial on 30 subjects. All inclusive, Group B (Trial group) rendered significantly better results over Group A (Control group) (p<0.05). The trial drug Katupila Arka showed immense range of chemical constituents which could be attributed to its rapid wound healing property. It is cost effective due to requirement of lesser amount of drugs and better healing, and can be applied in any group of subjects due to its better acceptability and safety. Hence, from the study it was concluded that, the drug Katupila Arka possesses high qualitative efficacy in “Vrana Ropana” with minimal scaring without producing any adverse effects.

Reference

1. Fugita F, Santos C, Ribeiro C. Epidemiological profile of patients with fistula in ano. Journal of Coloproctology [Internet].


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2020 [cited 2020 Feb 20];40(1):1-7. Available from: https://jcol.elsevier.es/en-epidemiological-profile-patients-with-fistula-articulo-s2237936319301285 DOI: 10.1016/j.jcol.2019.09.009

2. Jain B, Vaibhaw K, Garg P, Gupta S, Mohanty D. Comparison of a fistulectomy and a fistulotomy with marsupialization in the management of a simple anal fistula: a randomized, controlled pilot trial. Journal of the Korean Society of Coloproctology [Internet]. 2012;28(2):78-82.

3.Susruta, Susruta samhita. edited by Vaidya Jadavji Trikamji Acharya, Narayan Ram Acharya ‘kavyatirtha’. Sootrasthana.Ch. 22, Ver. 7. reprint 2017edition, Varanasi: Chaukamba Sanskrit Sansthan; 2017. p. 108.

4. Susruta, Susruta samhita. edited by Vaidya Jadavji Trikamji Acharya, Narayan Ram Acharya ‘kavyatirtha’. Chikitsa sathana.Ch.1, Ver. 8. Reprint 2017edition, Varanasi: Chaukamba Sanskrit Sansthan; 2017. p. 397.

5. Dudhamal T, Mahanta V, Gupta S, Ajmeer A. Topical application of Katupila (Securinega leucopyrus) in Dushta Vrana (chronic wound) showing excellent healing effect: A case study. AYU (An International Quarterly Journal of Research in Ayurveda) [Internet]. 2014;35(2):175.

6. Sweta K M, Aswin J S, P Bhat Ramesh. Evaluation of Katupila Arka in Post-Operative Fistulotomy Wound Management: A Case Report. J.Adv.Res.in Ayurveda,Yoga, Unnani, Sidhha & Homeopathy[Internet]. 2020;6(3&4 - 2019):14-6.

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13. Osman T A , Miris D, Nilgun O, Yilmaz M A, Hamdi T, Fatma T P. Comparative Studies on Phenolic Composition, Antioxidant, Wound Healing and Cytotoxic Activities of Selected Achillea L. Species Growing in Turkey. MDPI [Internet]. 2015 Oct; 20(10):95-9.


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