AshwathaKsheer Sutra and UdumberKsheer Sutra in the management of Bhagandara (Fistula in ano): An Ayurvedic management protocol for treatment of fistula in ano

Fistula in ano is tract lined by granulation tissue having internal opening in anal canal and rectum and external opening in the perianal region. The incidence of a fistula-in-ano developing from an anal abscess ranges from 26-38%. The prevalence of non-specific anal fistula has been estimated to be 8.6 to 10/100,000 of the population per year, with a male to female ratio of 8:1.in contemporary sciences Bhagandara  can be correlated with Fistula in Ano. To compare the efficacy of AshwathaKsheer Sutra  and UdumberKsheer Sutra in the management of Bhagandara (Fistula in ano).  The present study is designed as a  Randomized single blind parallel in which 40 patients will be enrolled. Patients will be distributed in two group with 20 patients in each group. In group A AshwathaKsheerSutra and in group B UdumbarKsheerSutra will be changed after 7 days till the cure of fistula. Assessment of the patients will be done on day 1st, 8th, 15th, and 22nd after intervention, follow up will be taken on 29th day.  Results will be drawn from the observations of objective parameters. Conclusion of the study will be drawn on the basis of statistical data calculated from the collected data.

Bhagandar, Fistula in ano, AshwathaKsheer Sutra, UdumbarKsheer Sutra A Fistula in ano is tract lined by granulation tissue having internal opening in anal canal and rectum and external opening in the perianal region. The incidence of a istula-in-ano developing from an anal abscess ranges from 26-38%. The prevalence of non-speci ic anal istula has been estimated to be 8.6 to 10/100,000 of the population per year, with a male to female ratio of 8:1.in contemporary sciences Bhagandara can be correlated with Fistula in Ano. To compare the ef icacy of AshwathaKsheer Sutra and UdumberKsheer Sutra in the management of Bhagandara (Fistula in ano). The present study is designed as a Randomized single blind parallel in which 40 patients will be enrolled. Patients will be distributed in two group with 20 patients in each group. In group A AshwathaKsheerSutra and in group B UdumbarKsheerSutra will be changed after 7 days till the cure of istula. Assessment of the patients will be done on day 1 st , 8 th , 15 th , and 22 nd after intervention, follow up will be taken on 29 th day. Results will be drawn from the observations of objective parameters. Conclusion of the study will be drawn on the basis of statistical data calculated from the collected data.

INTRODUCTION
SushrutSamhita can be compared with any book on surgery written centuries later. In context of chikitsa AcharyaSushruta has described almost all sort of surgical managements and some of them still have no comparison. More over in regards of anorectal and perineal surgeries, he has expounded much and equal emphasis is given to surgical as well as para surgical measures. Anorectal diseases like Arsha and Bhagandara are said callous to be cured and among them Bhagandara is considered under the AshtaMahaagad (Eight Grave Disorders) ( Sushrutsamhita, 2012) The term Bhagandara is etiologically originated from two Sanskrit words -Bhaga and Daran meaning tearing of perineum. Its classi ication and management including various local and systemic measures are the main objectives of the classical text. (Sharma, 2015)At irst it is present as Pidika and when it become pakwa or suppurate it forms Bhagandar. It causes Daran in Bhag, Guda and BastiPradesh. (Shastri, 2007) It can be correlated to Fistula in ano in modern medical sciences. Fistula in ano is tract lined by granulation tissue having internal opening in anal canal and rectum and external opening in the perianal region. Most istulas are thought to arise as a result of cryptoglandular infection with resultant perianal abscess. An abscess represents the acute in lammatory event, whereas the istula is representative of the chronic process (Williams et al., 2008). The incidence of a istula-in-ano developing from an anal abscess ranges from 26-38%. The prevalence of non-speci ic anal istula has been estimated to be 8.6 to 10/100,000 of the population per year, with a male to female ratio of 8:1 (Deeba et al., 2008).
At present most common surgical procedure adopted in the treatment of Fistula in ano are Fistulectomy, Fistulotomy, Flap advancement, LIFT, Glue, and Seton. These surgical management carries several complications like frequent damage to the anal sphincters muscles, faecal soiling, Rectal prolapse, anal stenosis, delayed wound healing, and even after complete excision of tract there are chances of recurrence (Deshmukh et al., 2019).
The Kshara sutra treatment is a safe, effective, ambulatory and unhazardous method of treatment in istula-in-ano. A multi centric study carried also con irmed that the method is very much effective and free form recurrence. However, the study also revealed that the time required for the treatment is essentially more than conventional surgery. It is also found that the pain factor is more in the Kshara sutra surgery over the istula-in -ano. Therefore, a quest is continuing to overcome certain disadvantages found with Kshara sutra. India is a vast country, with varied lora and there is also a need for search of the alternate plant sources which may give better results. In earlier studies it is reported that the latex expressed from certain plants can be very well used to prepare the Ksheer sutra which is having very good effect of istula-in ano by reducing the pain with the usual advantages of Kshara sutra, therefore a comparative study will be carried out to compare the effect of Ksheer sutra made of latex of Ashwatha and latex of Udumber (Trikamji, 2008)

Trial design
Randomized single blind parallel.

Study setting
Diagnosed patients will be selected from Shalyatantra OPD & IPD of M.G.A.C.H. and R.C. Wardha ( Figure 1).

Study design
Randomized clinical trial (single blind parallel)

III. Pregnancy
Iv. Malignancy will be excluded.

Criteria for discontinuing or modifying allocated interventions
Patients will be withdrawn from intervention if any harmful incidence, signs of drug allergy or any problem will occur; patient will be offered treatment free of cost till the disease subsided.

Secondary Outcomes
Ashwatha Ksheer and Udumbar Ksheer is available throughout India and it is safe, easily available, cost effective and best remedy for the management of Bhagandar.

Statistical analysis
Wilcoxon rank sum test.

Time duration till follow up
1 st , 8 th , 15 th , and 22 nd after intervention, follow up will be taken on 29 th day.

Time schedule of enrolment, interventions
Diagnosed patients of Fistula in Ano will be enrolled in the present study after ful illing the inclusion criteria ( Figure 2).

Interventions
KsheerSutra will be change every week till treatment. Common conservative treatment used in both the groups 1. Hot Sitz Bath-Twice a day 2. TriphalaGuggul-500mg/BD 3. Panchasakarchoorna -5gm/HS(SOS)  Groups 2 group each with minimum of 20 patients who are ful illing the criteria for inclusion (Table 1).

Implementation
Principal invigilator will register subject.

Randomized
Assessment criteria a) Objective criteria 1. Pain -Vas Scale.

Data management
Principal investigator will do coding of data.

Ethics and dissemination
Permission for research has been taken from Institutional Ethical Committee ref no.: MGACHRC/IEC/July-2020/53

Consent or assent
Written informed consent will be obtained from the patient.

Dissemination policy
For future research results will be disseminated and research will be published in reputed journal

Informed consent materials
All the research related document and consent form will be given to the patients.

DISCUSSION
Bhagandar is managed by various modern surgical and medical treatments, but all therapies have limitations and the chance of recurrence. Ayurved has its own way of treating Bhagandari.eKshar Sutra which is a minimal invasive para surgical measure capable of performing excision or Chhedan; by virtue of its mechanical pressure and phytochemical cauterization. Although the standard ApamargaKshar Sutra is used successfully, the dif iculties in its preparation and application are worth noting. Different research scholars have carried out studies to ind any other thread that can mitigate all these dif iculties. Among these is UdumbarKsheer Sutra. Various researches have been conducted on this Sutra but the product has not comparatively evaluated with AshwathaKsheerSutra. The Ashwatha (Ficusreligiosa) has shown signi icant antioxidant, wound healing and anti-in lammatory activity. AshwathaKsheer will be used in this present research work as it posses, scavenging activity, rapid wound healing activity, analgesic, anti-microbial, anti-bacterial anti-in lammatory (Sreelekshmi et al., 2007), antiulcer, antidiabetic activity and also available in abundance and in all seasons and its latex can be easily extracted out (Makhija et al., 2010). So to evalu-ate its ef icacy in the management of Bhagandar as well as its comparative evaluation with the ef icacy of UdumbarKsheer Sutra.

Time schedule of enrolment, interventions
Thread will be changed after every 7 day till the cut through of the tract. Assessment will be done on day1 st ,8 th ,15 th , and 22 nd after intervention, follow up will be taken on 29 th day. (Figure 2)

CONCLUSIONS
Ashwatha shows properties of pitta, sleshmavranastrajita which means it drains out kapha and pitta from the wound. The predicted outcome of this analysis is that group A with intervention is more effective intervention to group B. It is effective in cutting rate of istula track and subsides the symptom of Fistula in ano such as pain, discharge, itching. Patients who take all follow-up after treatment will have less chance of symptom reoccurrence.