E-ISSN:2456-3110

Research Article

Fissure-in-ano

Journal of Ayurveda and Integrated Medical Sciences

2022 Volume 7 Number 6 July
Publisherwww.maharshicharaka.in

A randomised controlled clinical study to evaluate the role of Nirvapana Upakrama with Durva ointment in the management of Pittaja Dushta Vrana with special reference to fissure-in-ano

Gopan P.1*, Padma.2, Sweta K.3, Surendranath D.4
DOI: http://dx.doi.org/10.21760/jaims.7.6.6

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

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

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

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

Introduction: Fissure-in-ano is an ulcer in the longitudinal axis of lower anal canal. It is having prevalence of about 17.91%. By seeing the signs and symptoms we can consider it as one among the six varieties of Dushta Vrana i.e., Pittaja Dustavrana. Due to busy life schedules people don’t prefer hospitalization and other operative procedures. So, there is a need to find out a new and simpler medicament which enables easy and better storage, preservation and mode of application. Here an attempt was made to study the effect of Nirvapana Upakrama in the management of fissure in ano is taken. This Upakrama is used for the treatment of Vrana accompanied with Daha, Paka, Jwara and having Pitta Kopa and Raktena Abhibhuta. Since fissure is having the similar symptoms this treatment can be adopted for the management of the same. Methodology: A randomized controlled clinical study was conducted over 30 subjects in two groups. Fifteen subjects were advised to apply Diltiazem gel and 15 subjects were advised to apply Durva ointment twice daily for a period of 14 days. Results: Rapid reduction in pain, burning sensation and length of ulcer was observed in the subjects who were given Durva ointment. Discussion: Durva ointment having Madura Rasa, Snigdha Guna and Sheeta Virya does Vatapitta Shamana and pacifies vitiated Rakta. Kashaya rasa of Durva does Vrana Ropana and Rakta Sthambana which amplifies in ulcer healing and relaxation of the sphincter.

Keywords: Fissure-in-ano, Pittaja Dushta Vrana, Durva Ghrita

Corresponding Author How to Cite this Article To Browse
Parvathy Gopan, Post Graduate Scholar, Department of Shalya Tantra, Sri Sri College of Ayurvedic Science and Research Hospital, Bengaluru, Karnataka, India.
Email: 		Parvathy Gopan, Padma, KM Sweta, Dhyan Surendranath, A randomised controlled clinical study to evaluate the role of Nirvapana Upakrama with Durva ointment in the management of Pittaja Dushta Vrana with special reference to fissure-in-ano. J Ayu Int Med Sci. 2022;7(6):35-45.
Available From
https://jaims.in/jaims/article/view/1945

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2022-05-28 2022-05-30 2022-06-06 2022-06-13 2022-06-20
Conflict of Interest Funding Ethical Approval Plagiarism X-checker Note
Nil Nil Yes 18%

© 2022by Parvathy Gopan, Padma, 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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Introduction

Human being suffered various health disorders since ages. Anorectal disorders are one among such ailment attributed to change in lifestyle and food habits. In the present era about 30-40% of the population are suffering from anorectal disorders.[1] Among them fissure-in-ano is one of the commonest having prevalence about 17.91%.[2] It is an ulcer in the longitudinal axis of lower anal canal, commonly occurs in midline posteriorly. It is more common in females.[3] In men 95% of anal fissure are posterior where as in females it constitutes 80%. “Parikarthika”- which literally means “Karthanavat Shoola” has been explained as a symptom in Virechana Vyapat having Vata Pitta predominance along with other symptoms like Gudadaha and Anilasanga. This has close similarity with “fissure-in-ano”, which has symptoms like pain, constipation, bleeding, and itching and canoe type ulcer formation.[3] When we analyse these signs and symptoms, we can find similarity with Pittaja Dustavrana i.e., Daha, Paka etc.[4]

Contemporary science offers both conservative as well as surgical management for fissure. Conservative treatments include stretching of anal sphincter, lord’s anal dilatation, use of laxatives, topical nitro glyceride application, and diltiazem 2% application. Surgical management like dorsal fissurectomy, lateral anal sphincterotomy, anal advancement flap etc. are also practiced. The major drawback seen in those are - prolonged convalescent period, continuous mucous discharge, hematoma formation, recurrent ulcer formation, risk of damage to the underlying sphincter.[3] When we look for a solution in Ayurvedic perspective, Shashti Upakrama mentioned in Susrutha Chikitsa comes to lime light. Here 60 modalities starting from Apatharpana to Rakshavidhana Vidhi are explained in details for the management of Vrana. Each of this Upakrama has an important role in management of various stages of Vrana.[6] Nirvapana is one among Shashti Upakrama explained for the treatment of Vrana accompanied with Daha, Paka, Jwara and having Pitta Kopa and Raktena Abhibhuta. Considering the similarity with fissure-in-ano in terms of symptoms, here an attempt to study the effect of Nirvapana Upakrama in the management of fissure was made. Here Acharya mentioned to use Seetha Guna Dravyas macerated in Ksheera added with Ghee as a Lepa[7]

over the Vrana. Commenting on the Sheeta Guna Dravyas in the context, Acharya Dalhana mentioned about Yoga Durvadi, which includes Durva, Nalamoola, Madhuka, Chandana etc.

As Durva is mentioned first and having properties like Kashaya Rasa, Seetha Virya, Kapha-Pittahara, Raktapitta Samaka and Daha Samana, it was taken here.[8] Ointment form, ensures easy application, better storage along with preservation makes it user friendly.

Thus, here an attempt to re-introduce and validate Nirvapana Upakrama one among Shashti Upakrama in an ointment form, which enables acceptance of Nirvapana Upakrama.

Aim and Objectives

Aim: To evaluate the role of Nirvapana Upakrama with Durva ointment in the management of Pittaja Dushtavrana with special reference to fissure-in-ano.

Objectives

1. To evaluate the role of Nirvapana Upakrama with Durva ointment in the management of fissure-in-ano.

2. To re-evaluate the role of diltiazem 2% gel in the management of fissure-in-ano.

3. To compare the role of Durva ointment and diltiazem 2% gel in the management of fissure-in-ano.

Materials and Methods

In this study 30 diagnosed cases of fissure-in-ano who fulfilled the inclusion criteria were selected from Out Patient and In Patients Departments of Shalya Tantra, SSCAS&RH, Bengaluru.

Groups of study

Number of thirty subjects suffering from fissure-in-ano fulfilling the inclusion criteria were selected by simple randomization technique. They were divided into two groups of fifteen each. Each group was given sitz bath followed by Triphala Choorna (dose 5-10g) at bed time as constipation is the main factor for fissure-in-ano.

Study Design: A randomized controlled clinical trial in which 30 subjects were divided into 2 groups of 15 each.


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Clinical Trial Group A Group B
Procedure Diltiazem ointment was applied twice daily after sitz bath. Durva ointment was applied twice daily after sitz bath.
Dose Quantity sufficient to cover the ulcer. Quantity sufficient to cover the ulcer.
Duration Two weeks Two weeks
Follow Up Fourteen days (21st and 28th day to observe any recurrence) Fourteen days (21st and 28th day to observe any recurrence)

Diagnostic criteria: Subjects with classical symptoms of fissure-in-ano were selected for study such as Guda Daha, Karthanavat Peeda, Anilasanga and those having characteristics of Pittaja Dushta Vrana.

Inclusion criteria

  • Clinically diagnosed cases of fissure-in-ano (Chronic Fissure-in-Ano were taken for the study.)
  • Patient irrespective of sex, religion, occupation and economic status. Patients between 21-60 years of age irrespective of both sexes.
  • Patients of fissure-in-ano with Diabetes and Hypertension which are under control, were also included in study.

Exclusion criteria

  • Fissure-in-ano secondary to ulcerative colitis, tuberculosis, syphilis, crohn’s disease, and other systemic diseases pertaining to colon were excluded from the study.
  • Previously diagnosed cases of Ca - rectum, Ca - colon and fistula-in-ano.

Assessment criteria: Following subjective and objective parameters will be considered in the study.

1. Subjective parameters

  • Gudagata Karthanavat Peeda (cutting and burning type of pain at anus.)
  • Itching
  • Bleeding
  • Constipation
  • Burning sensation
  • Pain assessment VAS Scale

Itching[9]

Grade 0 - Absent (no itching)

Grade 1 - Mild (Occasional itching)

Grade 2 - Moderate (Frequent itching)

Grade 3 - Severe (Continuous itching)

Burning sensation[9]

Grade 0 - No burning sensation

Grade 1 - Mild burning sensation

Grade 2 - Moderate burning sensation

Grade 3 - Severe Burning sensation.

Bleeding[1]

Grade 0 - No bleeding

Grade 1 - Bleeding per anum.

Constipation[1]

Grade 0 - Easy evacuation / Normal consistency

Grade 1 - Hard stools passed once daily

Grade 2 - Hard stools passed once in 2-3 days

Grade 3 - Very hard stools passed once in 3-4 days

2. Objective parameters

A.  Length of ulcer[1]

After gently parting the gluteal region, the fissure will be visualized and the length of ulcer is measured with a cotton swab by keeping it over the ulcer. This is later measured in millimetre.

B. Sphincter spasm[1]

(by per rectal digital examination.)

Grade 0 - Normal

Grade 1 – Spastic

Method of preparation

Durva ointment was prepared under 3 stages

1. Preparation of Durva Ghrita.

2. Conversion of Durva Ghrita into Durva Sikta Ghrita

3. Making and packing of Durva ointment

1. Preparation of Durva Ghrita.

Equipment’s

Vessels, measuring jar, gas stove, big spoons, wooden spatula, filters, tray, mixer grinder, weighing machine, cora cloth, tripod stand.


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Ingredients: Durva Panchanga - quantity sufficient, Milk - 2 litre, Kalka - 250gm, Ghrita - 1 litre, Durva Swarasa - 2 litre, Madhuchista - quantity sufficient.

  • Durva Panchanga was collected. Cleaned and washed properly.
  • From this Durva Swarasa 2L was prepared and Durva Kalka 250gm was prepared.
  • 1L Ghrita was taken in a clean open vessel, to which prepared Kalka was added and boiled in Mandagni with constant stirring.
  • Into that 2 litre of Durva Swarasa was added boiled in Mandhagni with constant stirring till Ghrita Siddha Lakshana were appreciated.
  • After cooling down, Ghrita was filtered using a clean cloth and store in an air tight container.

2. Conversion of Durva Ghrita into Durva Sikta Ghrita

  • Filtered liquefied Madhuchista was added to warm Durva Ghrita in 1:5 ratio respectively to make it a homogeneous mixture - Durva Sikta Ghrita.
  • A sample of this batch was sent for analysis which are prescribed for Lepa/ Malahara/ Kalimbu/ Pasai/ Medicated wax/ Cream/ Poultice mentioned in “Laboratory guide for the analysis of Ayurveda & Siddha formulations”, Central council for Research in Ayurveda & Siddha (CCRAS).

3. Making and packing of Durva ointment

  • The Durva Sikta Ghrita was warmed at constant temperature with the help of electric warmer, to maintain the liquid state of the Ghrita throughout the process.
  • 5ml of Durva Sikta Ghrita was poured into containers and allowed to cool down and packing done.

jaims_1945_01.JPGDurva Panchanga

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Ghrita

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Durva Kalka was added into Ghrita

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Durva Swarasa was added

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Mixture of Ghrita, Durva Kalka, Swarasa and milk


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Phenashanti in Ghrita

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End product

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Durva Ointment

Observations and Results

Observation during preparation of Durva ointment

  • Durva was difficult to pulverize to obtain Swarasa and Kalka.
  • 4 kg Durva Panchanga was needed for getting 2L Swarasa and 250 g Kalka.
  • Pleasant odour of the preparation was appreciated.

Observations during intervention

  • Ointments are the soft semisolid preparations, used for external application to the skin or mucous membrane where medicaments dissolved or suspended or emulsified in the base. (non irritating, uniformly distributed throughout the base, melt at body temperature etc.)[10]
  • Durva ointment seemed to have all the qualities of an ideal ointment.
  • Both interventions were easy to apply, non-irritant, maintained adequate moisture and showed no signs of infection.
  • It was observed that there was early recurrence in control group.

Results - Analytical result

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Table 1: Between the group comparison (BT & AT) for pain.

Pain Category N Mean Rank Sum of Ranks Mann-Whitney U Wilcoxon W Z p
BT   Group A 15 14.6 219 99   219   0.638   0.523  
Group B 15 16.4 246
AT   Group A 15 18 270 75   195   2.408   0.016  
Group B 15 13 195
FU   Group A 15 16 240 105   225   1   0.317  
Group B 15 15 225

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Table 2: Between the group comparison (BT & AT) for itching

Itching Category N Mean Rank Sum of Ranks Mann-Whitney U Wilcoxon W Z p
BT   Group A 15 15.17 227.5 107.5   227.5   0.249   0.804  
Group B 15 15.83 237.5
AT   Group A 15 17 255 90   210   1.795   0.073  
Group B 15 14 210
FU   Group A 15 16 240 105   225   1   0.317  
Group B 15 15 225

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Table 3: Between the group comparison (BT & AT) for bleeding

Bleeding Category N Mean Rank Sum of Ranks Mann-Whitney U Wilcoxon W Z p
BT   Group A 15 15 225 105   225   0.392   0.695  
Group B 15 16 240
AT   Group A 15 15 225 105   225   1   0.317  
Group B 15 16 240
FU   Group A 15 16.5 247.5 97.5   217.5   1.439   0.15  
Group B 15 14.5 217.5

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Table 4: Between the group comparison (BT & AT) for burning sensation

Burning Sensation Category N Mean Rank Sum of Ranks Mann-Whitney U Wilcoxon W Z p
BT   Group A 15 16.4 246 99   219   0.619   0.536  
Group B 15 14.6 219
AT   Group A 15 18 270 75   195   2.408   0.016  
Group B 15 13 195
FU   Group A 15 16 240 105   225   1   0.317  
Group B 15 15 225

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Table 5: Between the group comparison (BT & AT) for constipation

Constipation Category N Mean Rank Sum of Ranks Mann-Whitney U Wilcoxon W Z p
BT   Group A 15 15.93 239 106   226   0.365   0.715  
Group B 15 15.07 226
AT   Group A 15 15.5 232.5 112.5   232.5   0   1  
Group B 15 15.5 232.5
FU   Group A 15 15.5 232.5 112.5   232.5   0   1  
Group B 15 15.5 232.5

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Table 6: Between the group comparison (BT & AT) for sphincter spasm

Sphincter Spasm Category N Mean Rank Sum of Ranks Mann-Whitney U Wilcoxon W Z p
BT   Group A 15 16 240 105   225   0.598   0.55  
Group B 15 15 225
AT   Group A 15 16 240 105   225   0.598   0.55  
Group B 15 15 225
FU   Group A 15 15.5 232.5 112.5   232.5   0   1  
Group B 15 15.5 232.5

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Table 7: Between the group comparison (BT & AT) for length of ulcer

Length of ulcer (mm) Group A (n=15) Group B (n=15) Unpaired t test
Mean Sd Mean Sd t p
BT 7.1 2.0 7.8 2.0 -0.921 0.365
DT 3.3 2.4 1.7 1.0 2.509 0.018
AT 0.8 1.5 0.1 0.5 1.654 0.109
FU1 0.1 0.3 0.0 0.0 1 0.326
FU2 0.4 1.1 0.0 0.0 1.382 0.178

Table 8: Between the group comparison (BT & AT) for length of ulcer

Change in Length of ulcer (mm) Group A (n=15) Group B (n=15) Unpaired t test
Mean Sd Mean Sd t p
BT - AT 2.0 0.0 2.0 0.0    
AT - FU2 0.7 0.9 0.1 0.5 1.991 0.056
BT – FU2 2.0 0.0 2.0 0.0    

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There was a significant difference before and after the treatment between the groups with high clinical efficacy seen in Group B compared to Group A in respect to subjective and objective parameters.

Limitations

  • The adoption of intervention by the subjects were not under the supervision of the principal investigator.
  • Availability of fresh Durva during all seasons is difficult

Further Scope

  • This study is a part of Post Graduate research on small sample. So, it is recommended to be studied on large sample size to create more evidence based data.
  • Along with Durva other drugs mentioned by Acharya for Nirvapana Upakrama can also be tried for proving the efficacy of Vrana Chikitsa in the management of fissure in ano.
  • Not only Durva, combination of all those medicines mentioned in Misrakadyaya like Nalamoola, Madhuka, Chandana can be tried as a combination for further study.
  • Present study was conducted on chronic fissure-in-ano, similar study can also be concentrated on acute fissure in ano.

Control group

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Trial group

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Discussion

The pH was slightly acidic. As pH value within the wound milieu directly and indirectly influences all biochemical reactions taking place in the process of wound healing. It has been proven that the surface pH of a wound plays an important role in wound healing as it helps control infection and increase antimicrobial activity, oxygen release, angiogenesis, protease activity, and bacterial toxicity. Hence, pH of the drug may have influenced wound healing.[11] The presence of required spreadability, viscosity, thermal stability and the absence of rancidity, infers that Durva ointment contained right proportion of Madhuchista needed for an ointment. The sample was pathogen free and had negligible microbial load, suggestive of safe for therapeutic use.

Pain[12]: Significant reduction in pain may be due to Madura Rasa of Durva along with, Snigdha Guna of Goghruta, Ksheera and Madhuchista which are the main ingredient of Durva ointment, having Vatahara property. Also, reduction in pain can be due to presence of Alkaloids, Flavonoids, Saponins and Tannins.

Itching: This may be due to Kashaya Tikta Rasa of Durva which is helping in the Kaphahara property. Bleeding Raktasthambaka property along with Kashaya Rasa, Seetha Virya, Kapha - Pittahara, Raktapitta Samaka properties of Durva helped in reduction of bleeding and also can be due to the presence of Tannins, Saponins, and Glycosides.

Burning sensation[13]: Nirvapana Upakrama is used for the treatment of Vrana accompanied with Daha, Paka, Jwara and having Pitta Kopa and Raktena Abhibhuta. Here Acharya mention to give Seetha Guna Dravyas macerated in Ksheera added with Ghee to be applied as a Lepa. Properties of Durva like Kashaya Rasa, Seetha Virya, Kapha Pittahara, Raktapitta Samaka and

Daha Samana property along with Madura Rasa, Snigdha Guna, Pittahara and Dahasamana properties of Ghrita and Payas helped in the reduction of burning sensation.

Wound healing[14]: Vrana Ropana property of Madhuchista along with Kashaya Rasa, Seetha Virya, Kapha-Pittahara, Raktapitta Samaka property of Durva might have led to Vrana Ropana. The flavonoids present in Durva facilitate the healing process by increase in collagen and protein and decrease in lipid peroxide found during the inflammation.

Sphincter spasm[12]

Ghrita helps in reduction of the Rookshata of Vata and maintains normal tone of muscles. Flavanoids which are present in Durva having wound healing and Vedanasthapana properties helps in relaxation of sphincter. Durva is also having Madura Rasa, Seetha Virya which also aids in the Vatashamana.

Summarizing all results

Contemplating all these findings, it can be inferred that Durva ointment delivered better results than diltiazem gel in the management of fissure-in-ano.

Conclusion

Fissure is a longitudinal split in the anoderm of the distal anal canal which extends from the anal verge proximally towards, but not beyond, the dentate line. It is commonly seen in posterior bed due to direct pressure of stool and also due to less muscular support at the posterior aspect of the anus. In the classics we are not getting the apt correlation for fissure-in-ano as an individual disease; by seeing the signs and symptoms we can consider it as one among the six varieties of Dushta Vrana i.e., Pittaja Dushtavrana.[5]

Even though treatment modality includes both conservative and surgical techniques, prolonged convalescent period, continuous mucous discharge, hematoma formation, recurrent ulcer formation, risk of damage to the underlying sphincter and recurrence are the most common drawbacks seen in conventional treatment. Both the groups showed high statistical significance when compared within the group before and after treatment also during follow-up. Rapid reduction in pain, burning sensation and length of ulcer was observed in the subjects who were given trial drug


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comparing to the control drug. Overall clinical effect size with respect to majority of parameter is much higher in group B comparing to group A, clearly showing its superiority to Group A. Trial Group has shown better clinical and statistically significant result compared to control group. Therefore rejected null hypothesis and accepted alternate hypothesis [H1: The efficacy of Durva ointment in fissure-in-ano is better than the group receiving diltiazem gel 2%]

Reference

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2. Ranjit Chaudary, Chirag Shanthi Dausage. Prevalence of Anal Fissure in patients with Anorectal Disorders: A single – centre experience. Journal of Clinical and Diagnostic Research, 2019 Feb; Vol-13(2): PCO5-PCO7.

3. Das S. A Concise Textbook of Surgery, 10th edition. Kolkata: Dr. S. Das .13; 2018. P.1083-86.

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5. Susruta, Susruta Samhita, edited by Vaidya Jadavaji Trikamji Aacharya and Narayan Ram Acharya ‘Kavyatirtha’. Chikitsasthana.Ch.1,Ver.8. Reprint, 2015 edition, Varanasi: Choukhambha Sanskrit Sansthan, Kashi Sanshrit series 316;2015.p.397.

6. Susruta, Susrutasamhita, edited by Vaidya Jadavaji Trikamji Aacharya and Narayan Ram Acharya ‘Kavyatirtha’.Chikitsasthana. Ch.1,Ver.49-50. Reprint, 2015 edition Varanasi: Choukhambha Sanskrit Sansthan, Kashi Sanshrit series 316;2015.p.401.

7. Susruta, Susruta Samhitha, edited by Vaidya Jadavaji Trikamji Aacharya and Narayan Ram Acharya ‘Kavyatirtha’. Soothrasthan.Ch.37,Ver.4. Reprint, 2015 edition, Varanasi: Choukhambha Sanskrit Sansthan, Kashi Sanshrit series316;2015.p.160.

8. Tichkule SV, Khandare KB, Shrivastav PP. Proficiency of Khanduchakka Ghrita in the management of Parikarthika: A case report. J Indian Sys Medicine [serial online] 2019; 7:47-50.

9. Hiremath SG. A Textbook of Bhaishajya Kalpana (Indian Pharmaceutics). 17 Reprint, 2011 edition, Banglore: IBH Prakashana;p.476.

10. Basavaraj SN, Namdev MS, Bharat Wadher, Sohan Selkar. Acidic Environment and Wound Healing: A Review [Internet]. 2015 Jan;27(1):5-11.

11. Waldiceu A.VerriJr, Fabiana T.M.C, Vicentini, Marcela M.Baracat, Sandra R.Georgett, Renato D.R.Cardoso, Thiago M.Cunha. Flavonoids as Anti-Inflammatory and Analgesic Drugs: Mechanisms of Action and Perspectives in the Development of Pharmaceutical Forms. Studies in Natural Products Chemistry [Internet]. 2012 Feb; 32(36): 297-330.

12. Fatemeh E, Mohammadali T, Javad M, Hadi V. Medicinal Plants as Potential Hemostatic Agents. NIH[Internet]. 2020 Dec;23(1):10-23.

13. Meenakshi, Narendra Singh Shekhawat, Rajesh Gupta, Prof. O. P. Dave. A Comparative Clinical Study Of Durvadi Ghrita And Tankan Kshara In The Management Of Guda-Parikartika (Fissure-in-ano). Wjpmr[Internet], 2017,Aug;3(9) : 270-274.


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