Bhagandara is a common disease occurring in the ano-rectal region. Acharya Susruta, the father of surgery has included this disease as one among the Ashtamahagada. It can be correlated with Fistula-in-ano as described in western medical science. Fistula-in-ano is a track lined by granulation tissue which opens deeply in the anal canal or rectum and superficially on the skin around the anus. The incidence of a Fistula-in-ano developing from an anal abscess ranges from 26-38%. The prevalence in men is 12.3 cases per 100,000 populations and in women are 5.6 cases per 100,000 populations. The male to female ratio is 1.8:1. The mean age of patients is 38.3 years. This randomized prospective cohort clinical study was done to compare and evaluate the effect of new herbal formulation consisting of Vitex nigundo(root), Crativa adansoni (bark), Ricinus communis (bark), Plumbago indica(root) in managing fistula-in-ano conditions of patients in comparison to the effect of tripala decoction and kshara sutra. The patients were selected according to the selection criteria and randomly assign in to 2 groups (Group A, Group B) consisting of 20 patients for each. The patients of Group A was be treated with, Tripala decoction, kshara sutra and prescribed dietary management. The patients of group B were treated with, new herbal formulation, kshara sutra and prescribed dietary management during the period of 8 weeks. In the group A and group B mean changes or decrement of pain, burning sensation, itching and discharge, P values = 0.00 95% confidence level P < 0.05 both groups are same P=0.000. Therefore, no difference between both groups and it shows statistically significant. In the group A mean decrement of length of the fistulous track P value p = 0.005 at confidence level P < 0.05. It shows a significant decrement of the length of fistulous track statistically in 95% confidence level. In the group B mean decrement of length of fistulous track P value p = 0.000 at 95% confidence level P < 0.05. It shows a significant decrement of the length of fistulous track statistically in 95% confidence level.
But mean decrement of length of fistulous track of the group B greater than that of group A, which means group B more statistically significant. Finally, based on the observed results and the pharmacodynamic properties of both treatment protocols, it may be concluded that new herbal formulation + kshara sutra + dietary management treatment module is more effective than Tripala decoction + kshara sutra + dietary management in the management of fistula-in-ano.
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