Efficacy of Trivratyadi Taila as an Adjuvant to the IFTAK Procedure in the Management of Complex Fistula-in-Ano (Bhagandara): A Randomized Comparative Clinical Trial

Abstract

Background: Bhagandara (fistula-in-ano) is a chronic anorectal condition associated with significant morbidity. The IFTAK (Interception of Fistulous Tract with Application of Ksharasutra) procedure is a minimally invasive Ayurvedic surgical technique with established efficacy in complex fistulae.6 However, postoperative sequelae including pain, purulent discharge, itching, and swelling remain clinical challenges. Trivratyadi Taila, a classical Ayurvedic medicated oil formulation described by Acharya Sushruta,16 possesses Shodhana (wound-cleansing), Ropana (healing), and anti-inflammatory properties potentially relevant to postoperative wound management. Aim: To evaluate and compare the clinical efficacy of IFTAK alone versus IFTAK combined with local application of Trivratyadi Taila in the management of Bhagandara. Methods: A randomized, open-label, comparative clinical trial was conducted on 40 patients with complex fistula-in-ano, divided equally into Group A (IFTAK alone, n=20) and Group B (IFTAK + Trivratyadi Taila, n=20). Subjective parameters like pain (Visual Analogue Scale), discharge, itching, and swelling, were assessed at baseline, 1st post-operative day, and weekly for one month. Intra-group analysis employed the Wilcoxon signed-rank test; inter-group comparison used the Mann-Whitney U test (p < 0.05). Results: All 40 patients completed the trial. Group B demonstrated significantly superior outcomes at one month: pain relief 84% vs. 62.26% (p < 0.0001), discharge reduction 82.86% vs. 44.83% (p < 0.0001), itching improvement 83.87% vs. 43.48% (p = 0.0004), and swelling reduction 86.79% vs. 65% (p < 0.0001). Conclusion: Adjuvant application of Trivratyadi Taila following IFTAK significantly enhances postoperative outcomes in complex fistula-in-ano. This integrative approach warrants inclusion in standardized postoperative protocols for Bhagandara management.

Introduction

The text discusses fistula-in-ano, a chronic anorectal condition characterized by an abnormal tract causing pain, discharge, and recurrent infections, significantly affecting quality of life. It is more common in males and often difficult to treat, especially in complex cases where no single surgical method is universally effective.

The Ayurvedic IFTAK technique (Interception of Fistulous Tract with Ksharasutra) is highlighted as a minimally invasive and effective treatment with high success rates. However, postoperative issues like pain, discharge, and swelling remain concerns.

To address this, the study evaluates the use of Trivratyadi Taila, an herbal formulation with antimicrobial and healing properties, as an additional postoperative treatment. A randomized clinical trial with 40 patients compared standard IFTAK care (control group) with IFTAK plus Trivratyadi Taila (trial group).

Patients were assessed over four weeks based on symptoms such as pain, discharge, itching, and swelling using statistical analysis methods. The study aims to determine whether adding Trivratyadi Taila improves recovery and overall outcomes compared to standard treatment alone.

Conclusion

This randomized comparative trial demonstrates that adjuvant local application of Trivratyadi Taila following the IFTAK procedure provides statistically and clinically superior postoperative outcomes in complex fistula-in-ano compared to IFTAK alone. Group B achieved markedly higher relief across all parameters, pain (84%), discharge (82.86%), itching (83.87%), and swelling (86.79%), with highly significant inter-group differences at trial completion (p < 0.0001). The convergent antimicrobial, anti-inflammatory, and tissue-regenerative pharmacological actions of Trivratyadi Taila’s constituent herbs16 justify its inclusion as a standardized adjuvant in postoperative care protocols for Bhagandara managed by IFTAK. Multicentre trials with larger cohorts, objective wound assessment, and extended follow-up are warranted to confirm these findings.

References

[1] Sainio P. Fistula-in-ano in a defined population: incidence and epidemiological aspects. Ann Chir Gynaecol. 1984;73(4):219–224. [2] Maksimovic J, Maksimovic M. From history of proctology. Arch Oncol. 2013;21(1):28–33. [3] Keighley MRB, Williams NS, editors. Surgery of the Anus, Rectum and Colon. 3rd ed. Philadelphia: Saunders Elsevier; 2008. pp. 420–491. [4] Williams G, Williams A, Tozer P, et al. The treatment of anal fistula: second ACPGBI position statement – 2018. Colorectal Dis. 2018;20(Suppl 3):5–31. [5] Vogel JD, Johnson EK, Morris AM, et al. Clinical practice guidelines for the management of anorectal abscess, fistula-in-ano and rectovaginal fistula. Dis Colon Rectum. 2016;59(12):1117–1133. [6] Sahu M, Singh M. Interception of fistula track with application of Ksharsutra (IFTAK) in the management of fistula-in-ano. In: Sahu M, editor. A Manual on Fistula-in-Ano and Ksharasutra Therapy. Varanasi: National Resource Centre on Ksharasutra Therapy, BHU; 2015. pp. 184–220. [7] Sherkhane R, Meena P, Hanifa N, Mahanta VD, Gupta SK. IFTAK technique: an advanced Ksharasutra technique for management of fistula-in-ano. J Ayurveda Integr Med. 2020;11(3):382–387. [8] Kulsoom F, Dutt B, Mahanta V, Gupta SK, Sherkhane R. Management of complex fistula-in-ano by IFTAK technique: a case report. J Ayurveda Integr Med Sci. 2020;5(6):287–291. [9] Kumar A. Complex anal fistula treated with IFTAK (Interception of Fistulous Tract and Application of Ksharasutra). Int J AYUSH Case Rep. 2023;7(2):45–50. [10] Goud AD, Raja MDP, Pachchinavar KH, Yakkundi RC, Mohan GV. A clinical comparative study of Vishyandana Taila and Kashisadi Taila in management of Bhagandara (Fistula-in-Ano). Int Res J Ayurveda Yoga. 2021;4(12):01–06. [11] Bhargava A. A clinical evaluation of Madhukadi and Jatyadi Taila along with standard Ksharasutra therapy w.s.r. to unit cutting time in the management of Bhagandara (Fistula-in-Ano). Innovare J Ayurvedic Sci. 2013;1(2):1–5. [12] Kulkarni AD, Yakkundi RC, Ganachari AB. Effect of Saindhavadya Taila in the management of Bhagandara after IFTAK: a case study. J Ayurveda Integr Med Sci. 2023;8(4):112–116. [13] Parhi PR, Singh B, Nirmal S, Baghel DS, Sahu SK, Diwaker D. Surgical management of Bhagandara by IFTAK technique along with Aragwadhadi Varti. Ayushdhara. 2025;12(1):23–29. [14] Deshpande PJ, Sharma KR. Treatment of fistula-in-ano by a new technique: review and follow-up of 200 cases. Am J Proctol. 1973;24:49–60. [15] Srivastava P, Sahu M. Efficacy of Ksharasutra therapy in the management of fistula-in-ano. World J Colorectal Surg. 2010;2(1):Article 6. [16] Shastri A, editor. Sushruta Samhita of Sushruta with Ayurveda Tattva Sandeepika Hindi commentary, Chikitsa Sthana, Chapter 8, Verses 48–49. Reprint ed. Varanasi: Chaukhambha Sanskrit Sansthan; 2009. [17] Zheng T, et al. Prevalence of anal fistula in the European Union: a systematic review and meta-analysis. Int J Colorectal Dis. 2022;37(6):1225–1233. [18] Patel RD, et al. A clinical study of fistula-in-ano and its management. Int Surg J. 2017;4(4):1372–1376. [19] Parks AG. Pathogenesis and treatment of fistula-in-ano. Br Med J. 1961;1:463–469. [20] Aadithyaraj KT, Pandey AK, Katkar S, et al. IFTAK technique for management of anterior fistulae-in-ano (female anterior fistula series). Tech Coloproctol. 2025 [Epub ahead of print].

Copyright

Copyright © 2026 Dr. Maninder Singh Sisodiya, Dr. Sanjay Srivastava, Dr. Shaloni Sharma, Dr. Tanishka Gupta. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.