A clinical study to evaluate the effect of per-rectal instillation of Kaseesadi Taila in the management of Parikartika W.S.R. to Fissure-in-Ano

 Corresponding author: Pulkita Sharma. Copyright © 2025 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0. A clinical study to evaluate the effect of per-rectal instillation of Kaseesadi Taila in the management of Parikartika W.S.R. to Fissure-in-Ano Pulkita Sharma * SDMT’s Ayurvedic Medical College, Terdal, Karnataka, India. World Journal of Biology Pharmacy and Health Sciences, 2025, 21(01), 533-540 Publication history: Received on 06 December 2024; revised on 21 January 2025; accepted on 24 January 2025 Article DOI: https://doi.org/10.30574/wjbphs.2025.21.1.0057 Abstract Background: In today’s world, a sedentary lifestyle, irregular diet, and stress often lead to digestive disturbances, resulting in various ano-rectal disorders, with fissure-in-ano being particularly troublesome. This condition affects health and daily functioning, and contemporary treatments often have limitations and side effects. Ayurvedic therapy, with its holistic approach, offers significant benefits. Ayurvedic treatments include Bhesaja, Shashtra, and Kshara Karma. Modern topical remedies are also available for wound healing, including Fissure-in-ano. This study focuses on Kaseesadi Taila functions like Kshara, shrinking and healing wounds without harming anal sphincters, and may be utilized for treating Parikartika as a standardized and accessible treatment modality. Aim and objective: To evaluate the effect of per rectal instillation of Kaseesadi Taila in the management of Parikartika W.S.R. to Fissure-in-ano. Methodology: Single arm open label clinical study was conducted to evaluate the effect of Kaseesadi Taila in Parikartika for 30 days Results: There were statistically significant results seen in both subjective and objective parameters. The results were encouraging in terms healing. Interpretations: Kaseesadi Taila has Lekhana, Shodhana, Ropana & Raktasthambana properties. It was observed that Kaseesadi Taila is good, safe, easily accessible, and effective treatment modality for Parikartika. Conclusion: Kaseesadi Taila showed good efficacy in almost all the patients and emerge as an effective drug in treatment of Parikartika. Keywords: Parikartika; Kaseesadi Taila; Fissure-in-ano; Shodhana; Ropana; Raktasthambana 1. Introduction In contemporary world, sedentary lifestyle, change in diet and food timings, mental stress results in digestive disturbances which leads to various ano-rectal disorders. One of the most commonly troubling diseases is Fissure-inano with prevalence of around 1 in every 350 adults1. 95% of anal fissures in men are posterior, 5% are anterior. 80% of anal fissures in females are posterior, 20% are anterior2, World Journal of Biology Pharmacy and Health Sciences, 2025, 21(01), 533-540 534 An Anal Fissure is a longitudinal split in the anoderm of the distal anal canal3. Fissure occur most commonly in midline posteriorly (90%) and much less commonly anteriorly (10%)4. It typically causes severe intolerable pain which is similar to excruciating pain in Parikartika as mentioned by Acharya Sushruta5. On the basis of Lakshanas Parikartika can be correlated with Fissure-in-ano. Parikartika is mentioned in Bruhatrayees as the complication of Basti6,7 and Virechana Karma5,8,9. Parikartika literal meaning is “Parikartanvat Vedana” i.e., cutting type of pain around anal region10. Modern treatment modalities include soothing ointments, bulk laxatives, surgeries like lateral internal sphincterotomy, V-Y advancement flap, are told, possibility of high recurrence, risk of incontinence, formation of fistula or abscesses are seen in some cases and are quite expensive. According to classics, there are several treatment modalities like Bhesaja, Shashtra, Kshara Karma. Nowadays many topical remedies are available for local application of wound healing in market including Fissure-in-ano. In present study an effort is made to make a standard and easily accessible treatment. In Gadanigraha, it is mentioned that Kaseesadi Taila works like a Kshara but does not affect the functions of the anal sphincters11. In Rasatarangini, external use of Kaseesa is considered to be Sankochankarana param i.e., it helps to reduce the size of wound and heals it12. Kaseesa also have Vranashodhana, Vranaropana, Raktsthambana properties13. This research work was done to see the effect of Kaseesadi Taila in the management of Parikartika. Aim and objective To evaluate the effect of per rectal instillation of Kaseesadi Taila in the management of Parikartika W.S.R. to Fissure-inano 2. Material and methods 30 subjects were selected for the trial on the basis of inclusion criteria. Study Design: A single arm open label clinical study Table 1 intervention Route of instillation Per Rectal Sample size 30 Medicine Kaseesadi Taila Dose 10 ml Duration of drug intervention 7 days Assessment was done on 0th ,7th ,14th, 30th days Follow Up 14th and 30th days 2.1. Procedure Per-rectal instillation of Kaseesadi Taila was done to each subject in the dose of 10ml, once a day for a period of 7 days. 2.2. Assessment parameters As per the REALISE SCORE questionnaire14, World Journal of Biology Pharmacy and Health Sciences, 2025, 21(01), 533-540 535 2.3. Subjective parameters Table 2 Gudagata vedana (pain) - vas scale Grade Pain 0 No pain(0) 1 Mild pain(1-3) 2 Moderate pain(4-6) 3 Severe pain(7-9) 4 Very Severe pain(10) Table 3 Gudagata daha (burning sensation after defecation) Grade Duration 0 Never 1 Less than 1 hour 2 More than 1 hour and less than or equals to 2 hours 3 More than 2 hours and less than or equals to 3 hours 4 More than 3 hours and less than or equals to 4 hours 5 More than 4 hours Table 4 Gudagata rakta srava (bleeding) Grade Bleeding 1 Never 2 Rarely, (less than or equals to 25% of defecations) 3 Sometimes, (more than 25% and less than or equals to 50% of defecations) 4 Often, (more than 50% and less than or equals to 75% of defecations) 5 Always, (more than 75% of defecations) 2.4. Objective parameters Table 5 Sphincter tonicity Grade Sphincter Tonicity 0 Normal 1 Hypotonicity 2 Hypertonicity Table 6 Size of fissure Grade Size 0 No Fissure 1 Small (1-5 mm) 2 Medium (6-10 mm) 3 Large (> 10 mm) World Journal of Biology Pharmacy and Health Sciences, 2025, 21(01), 533-540 536 Table 7 Site of fissure Grade Site 0 No fissure 1 Midline Anterior 2 Midline Posterior 3 Antero-posterior 4 Multiple 3. Observations and results Data was collected, tabulated and analyzed. Friedman test and Wilcoxon sign rank test were applied within the groups to obtain the results. Table 8 Effect of treatment on gudagata vedana (pain) PAIN BT(N) PERCENTAGE AT(N) PERCENTAGE NO PAIN (0) GRADE 0 0 0.0% 28 93.33% MILD (1-3) GRADE 1 0 0.0% 0 0.0 MODERATE (4-6) GRADE 2 16 53.3% 2 6.6% SEVERE (7-9) GRADE 3 14 46.7% 0 0.0% VERY SEVERE (10) GRADE 4 0 0.0% 0 0.0% Table 9 Effect of treatment on gudagata daha (burning sensation after defecation) TIME BT(N) PERCENTAGE AT(N) PERCENTAGE NEVER 0 0% 26 86.6% <1 HR 7 23.3% 4 13.33% >1 HR AND < OR = 2 HR 12 40.0% 0 0.0% >2 HR AND < OR = 3 HR 4 13.3% 0 0% >3 HR AND < OR = 4 HR 7 23.3% 0 0% >4 HR 0 0.0% 0 0% Table 10 Effect of treatment on gudagata rakta srava (bleeding) Gudagata raktasrava (bleeding) Bt(n) Percentage At(n) Percentage Never 4 13.3% 28 93.33% Rarely, (less than or equals to 25% of defecations) 6 20.0% 2 6.6% Sometimes, (more than 25% and less than or equals to 50% of defecations) 8 26.7% 0 0% Often, (more than 50% and less than or equals to 75% of defecations) 6 20.0 0 0% Always, (more than 75% of defecations) 6 20.0 0 0% World Journal of Biology Pharmacy and Health Sciences, 2025, 21(01), 533-540 537 Table 11 Effect of treatment on sphincter tonicity Sphincter tonicity Bt(n) Percentage At(n) Percentage Normal 6 20.0% 28 93.33% Hypotonicity 0 0.0% 1 3.3% Hypertonicity 24 80.0% 1 3.3% Table 12 Effect of treatment on size of fissure Size of fissure Bt(n) Percentage At(n) Percentage No fissure 0 0.0% 26 86.6% Small (1-5 mm) 9 30.0% 4 13.3% Medium (6-10 mm) 21 70.0% 0 0% Large (> 10 mm) 0 0% 0 0% Table 13 Effect of treatment on site of fissure Site of fissure Bt(n) Percentage At(n) Percentage No fissure 0 0% 26 86.6% Midline anterior 8 26.7% 2 6.6% Midline posterior 10 33.3% 2 6.6% Antero-posterior 12 40.0% 0 0% Table 14 Overall effect of treatment Grading Effect of treatment No. Of patients Grade 0 No Relief (0-25%) 0 Patient Grade 1 Mild Relief (26-50%) 2(6.6%) Patients Grade 2 Moderate Relief (51-75%) 2(6.6%) Patients Grade 3 Marked relief & Cured (76-100%) 26(86.6%) Patients Among 30 patients, 2(6.6%) patients had shown improvement in symptoms, 2(6.6%) patients cured from the disease but disease recurred during the course of study. 26(86.6%) patients had cured with no recurrence. 4. Discussion At the end of treatment, 26 patients showed good response where there was complete healing of fissure and relief from all associated symptoms. And 2 patients showed poor response towards treatment, whereas in 2 patients recurrence of fissure was observed. The good response in patients may be due to the therapeutic action of Kaseesadi Taila and following Pathya. Poor responses and recurrence may be due chronicity of ulcer, fibrosis of ulcer and not following the Pathya properly. The results analyzed statistically were significant & show quick action of Kaseesadi Taila with minimal recurrence. World Journal of Biology Pharmacy and Health Sciences, 2025, 21(01), 533-540 538 4.1. Effect on pain (Gudagata Vedana) Painful defecation was found in all patients (100%) before treatment.26 patients got relief after treatment. But 4 patients didn’t get complete relief. This might be due to Vranaropaka (Wound healing), analgesic, anti-inflammatory and rubefacient properties of Kaseesadi Taila. It acts like Kshara (Alkali) & irritates the anal musculature, dilates the blood vessels leading the increase in blood circulation that promotes healing, thus relieves the intensity of the pain. 4.2. Effect on bleeding (Gudagata Raktasrava) Among the 30 subjects, 26 patients had bleeding. 24 subjects got relief from bleeding.This may be due to Kshara property of Kaseesadi Taila which leads to Hemostasis. 4.3. Effect on burning sensation (Gudagata Daha) Among the 30 patients, 23 patients had burning sensation. All patients got relief from burning sensation to some extent. Kaseesadi Taila by virtue of its action relaxes the anal musculature by Snehana (Oleation), increases blood circulation and enhances drainage of inflammatory markers thus relieves the burning sensation. 4.4. Effect on Size of Fissure Among the 30 patients, all patients had Fissure. 26 patients got relief from Fissure. This might be due to Vranaropana and Vranasodhana (wound debriding) properties of Kaseesadi Taila. Kaseesa also have a property of Vranasankochkara Param i.e., reduces the size of fissure and heals it. Kaseesadi Taila also increases blood circulation, which provides necessary environment for healing of Fissure. 4.5. Effect on Sphincter tone Among the 30 patients, 24 patients had Hypertonicity. 22 patients got relief from hypertonicity. This may be due to spasmolytic activities, and better lubrication of anal canal procured by Kaseesadi Taila which relaxes the sphincter of anal canal. 4.6. Site of Fissure Among the 30 patients, 12 patients had multiple fissures. 10 patients had Posterior fissure, 8 patients had anterior fissure. 26 patients got relief. Reason for posterior location is explained as due to posterior angulation of anal canal, relative fixation of anal canal posteriorly, divergence of fibre of external sphincter muscle posteriorly. As the hard stool descends down, it first strikes the posterior median raphae and emerges out of anal orifice. Majority of anterior fissures were found in females in this study. Most of them were married and multiparous and gave a history of assisted labour with episiotomy. A probable explanation is that they developed fissure due to a damaged pelvic floor. The anterior wall of anal canal is less supported and over stretching of the wall during labour as well as on passing a hard column of stool is possible, leading to a tear. 4.7. Discussion on probable mode of action of Kaseesadi taila The probable mode of action of Kaseesadi Taila in the treatment of Parikartika (fissure-in-ano) can be elucidated through its multifaceted actions of cleansing, wound healing, infection prevention, inflammation reduction, and pain relief. By addressing both the symptoms and the underlying pathology of the fissure, it facilitates effective healing. Kaseesadi Taila alleviates pain and discomfort via its Vata-pacifying properties and also ensures smoother bowel movements, thereby preventing the aggravation of the condition. Below is an in-depth analysis: 4.7.1. Cleansing (Shodhana) and Debridement (Lekhana) Action: The ingredients Kaseesa, Kushtha, and Chitraka possess potent Lekhana (scraping) and Shodhana(cleansing) properties, which are instrumental in removing necrotic tissue, pus, and unhealthy granulation. This cleansing action is essential for preparing the fissure for healing, facilitating debris removal, and allowing for the regeneration of healthier tissue. 4.7.2. Wound Healing (Vranaropana) Components such as Kaseesa, Manhashila, and Karvira enhance Vranaropana (wound healing) by stimulating processes like neovascularization, epithelialization, and granulation. These processes are vital for accelerating the healing of the fissure through the formation of new blood vessels and granulation tissue. World Journal of Biology Pharmacy and Health Sciences, 2025, 21(01), 533-540 539 Tila Taila as base provides moisture (Snigdha Guna) to the affected area, preventing excessive dryness and promoting rapid healing. 4.7.3. Hemostasis (Raktasthambana): Kaseesa and Gomutra exhibit Raktasthambana properties that effectively control bleeding in the fissured region. This haemostatic action is critical for managing minor bleeding associated with the fissure, thereby supporting the wound healing process. 4.7.4. Anti-inflammatory (Sothahara) Effect The formulation contains Kaseesa, Sunthi, and Chitraka, which demonstrate significant Sothahara properties. These ingredients work to reduce swelling, redness, and inflammation in the anal region, thereby alleviating discomfort associated with Parikartika and promoting healing. Sunthi also plays a role in modulating vascular smooth muscle responses, further diminishing local inflammation. 4.7.5. Antimicrobial (Krumighna) Action Ingredients such as Vidanga, Chitraka, Danti, and Kaseesa exhibit Krumighna properties that are essential for preventing infections in the fissured area. This antimicrobial activity is crucial for maintaining a clean wound and avoiding complications like secondary infections. Additionally, Gomutra contributes to the antimicrobial and antiseptic properties of the formulation, ensuring that the wound remains free from external bacterial contamination and fostering an environment conducive to healing. 4.7.6. Pain Relief (Vedananashaka) and Vata-pacifying (Vatahara) Action The formulation effectively pacifies Vata Dosha, a significant contributor to the pain and discomfort experienced in Parikartika. The Ushna and Snigdha properties of Tila Taila counteract Vata Dushti, alleviating pain and discomfort. The Vatahara effect further enhances its Vedananashaka Guna, providing substantial relief from pain, reducing spasms, and easing discomfort associated with defecation. 4.7.7. Facilitating Smooth Bowel Movements The Snighdha Guna of Tila Taila serves as a lubricant for the anal canal, minimizing friction and preventing further injury during defecation. This lubricating effect is crucial for facilitating smoother bowel movements, thereby assisting in the management and prevention of exacerbation of anal fissures. 4.7.8. Deep Tissue Penetration The Teekshana Guna and Ushna Virya of majority ingredients ensure that the active constituents of Kaseesadi Taila penetrate deeply into the tissues, thereby enhancing its therapeutic effect and accelerating tissue regeneration and wound healing. 5. Conclusion Management of Fissure-in-ano by using Kaseesadi Taila was found to be effective in relieving pain, burning sensation, bleeding and healing of Fissure in ano. It lubricates the anal canal and provided easy evacuation of feces and thus promotes healing & relieving symptoms quickly and with minimal recurrence. Compliance with ethical standards Disclosure of conflict of interest There are no conflicts of interest. World Journal of Biology Pharmacy and Health Sciences, 2025, 21(01), 533-540 540 References [1] Monson John RT, “Anal Fissure-Basics-Epidemiology”. Best Practice. British Medical Journal.23 April 2012. Retrieved 30 June 2012. [2] M. Bhat Sriram. SRB’s Manual of Surgery. Chapter 25, Rectum and Anal Canal, Jaypee Brothers Medical Publishers, New Delhi, Ed-6, :967. [3] Dr. Yadav S, Dr Y K Ashutosh, Literally Review of Parikartika w.s.r. to Fissure-in-ano, World Journal of Pharmaceutical and Medical Research, 2020,6(8):361-364. [4] Dr. Das S. A Concise Textbook of Surgery, Chapter 45, The Rectum and Anal Canal, Old Dr. S. Das Publications, Kolkata, Ed-11: 1083. [5] Prof. Srikantha Murthy K R, Illustrated Sushruta Samhita, Chikitsa Sthana. Chapter 34, Shloka 16, Chaukhambha Orientalia, Varanasi. Edition 2019.:325 [6] Kashinath P S and Dr. C Gorakhnath, Savimarsha- ‘Vidhyotini’- Hindi Vyakhayopeta, Charaka Samhita Siddhi Sthana. Chapter 7, Shloka 54-57, Chaukhamba Bharati Academy, Varanasi, Edition 2016: 1041 [7] Prof., Srikantha Murthy K R Illustrated Sushruta Samhita, Chikitsa Sthana, Chapter 36, Shloka 36-37, Chaukhambha Orientalia Varanasi, Edition 2019.: 342 [8] Dr. Tripathi B, Nirmala Hindi commentary Ashtanga Hridyum, Kalpasiddhi Sthana, Chapter 3, Verse 15, Chaukhamba Sanskrit Pratishthana, Delhi-2022,: 845. [9] Kashinath P S and Dr. C Gorakhnath, Savimarsha- ‘Vidhyotini’- Hindi Vyakhayopeta Charaka Samhita, Siddhi Sthana. Chapter 6, Shloka 64-67, Chaukhamba Bharati Academy, Varanasi, Edition 2016,:1028. [10] Mugnoor S, Shilpa PN. Role of Triphladi Taila Matra Basti in Parikartika: A Single Case Study. Journal of Ayurveda and Integrated Medical Sciences. 2019 Aug 31;4(04):359-61 [11] Dr Kanjiv L, Bhaishajya Ratnavali by Govind Das, Chapter 9, Shloka 206, Chaukhambha Sanskrit Bhawan, Varanasi, Edition 2006,: 612. [12] Pandit Shashtrina Kashinath, Rastarangini-Pranacharya Srisadanandsharmna Virachita, Chapter 21 taranga, Shloka 233, Motilal Banarasidas Publications-2014, 8th Edition: 564 [13] Pandit Shashtrina Kashinath, Rastarangini-Pranacharya Srisadanandsharmna Virachita Chapter 21 taranga, Shloka 44, 51, 46, Motilal Banarasidas Publications-2014, 8th Edition :464,466,472. [14] Picciariello A, Lobascio P.,Spazzafumo, L., Rinaldi, M., Dibra, R., Trigiante, G., Laforgia, R., Pezzolla A, Altomare DF. THE REALISE score: a new statistically validated scoring system to assess the severity of anal fissures. Techniques in Coloproctology. 2021 Aug;25 (8): 935-940.