An open-label double-arm clinical study to evaluate the effect of Agnikarma using Panchaloha shalaka in comparison with Diathermy in partial internal sphincterotomy and healing of chronic fissure-in-ano.

Anal fissures typically arise as a tear at the anoderm with periodic anal pain and bleeding associated with bowel movements if it is left untreated or improper treatments leads to chronic anal fissure. In this condition, the conservative treatment will not be effective, and to get immediate and sustained relief we must consider surgical or para-surgical management. This can be corelated with guda parikartika which is caused by improper virechana and vasthikarma is characterized by cutting type of pain in guda pradesha as the main symptom.Acharya Sushruta, while describing Agnikarma, described its indication in Vrana, which is difficult to heal and helps in preventing the recurrence of the disease.The Agnikarma is the ayurvedic concept of transferring direct heat with the help of shalaka to produce a therapeutical burn. The therapeutic heat enhances blood circulation to the adjacent tissues, relieves sphincter spasm, and increases the metabolism, thus bringing about relief of symptoms.Agnikarma with Panchaloha shalaka seems to have less scientific validation with respect toSphincterotomy, removing fibrosed margins, as well as in removal of slough and dead tissues.The study is intended to provide evidence and revalidate cauterization with Panchaloha shalaka in healing of Parikartika.With the help of this principle, the removal of fibrosed tissue can be done by using Panchaloha shalaka which can make specific strokes with no blood loss and compares its efficacy with Diathermy. In this study a specially designed temperature gauged Panchaloha shalaka measured at 350°C at an interval of 2 seconds and cauterization is done superficially over the fibrosed tissue in one group and in another group Superficial cauterization will be done using monopolar diathermy probe set to coagulation mode at 26W for 2 seconds in different strokes so that the effect reaches the fibrosed tissue.In this study, 30 patients irrespective of sex, with age limit of 20 to 60 years, satisfying the inclusion criteria will be recruited. The assessments will be done for duration and severity of pain, burning sensation, bleeding, healing of wound, sphincter tone and constipation on 0th day, 7th day, 14th day, 21st day and 28th day. Quality of life on 0th, 28th and 60th days. Wilcoxon signed rank test and Man Whitney U test will be used for statistical analysis