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\def\RunningAuthor{Kiran Khandare et al.}
\firstPage{7999}
\articleType{Original Article}
\receivedDate{23 Oct 2020}
\acceptedDate{02 Dec 2020}
\revisedDate{28 Nov 2020}
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\journalDoi{ijrps.v11i4.4726}
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\title{\textbf{Effect of Ashwini Mudra as an adjuvant on pain in post-operative cases of ano-rectal diseases - An Ayurvedic management protocol}}
\author{Kiran~Khandare\textsuperscript{*}\textsuperscript{1},  
            Pradnya~Ghormode\textsuperscript{2},  
            Rahatsaba~S~Sayyed\textsuperscript{1}, 
            Alok~Kumar~Diwedi\textsuperscript{1}~\\[5pt]{\textsuperscript{1}Department of Shalyatantra, Mahatma Gandhi Ayurved College Hospital and Research Centre. Salod (H) Wardha, Datta Meghe Institute of Medical Sciences, Wardha-442001, Maharashtra, India}~\\{\textsuperscript{2}Department of Rachana Sharir, DMM Ayurved Mahavidyalaya, Yavatmal-445001, Maharashtra, India}}

\begin{abstract}
Ano-rectal disorders refer to the illness of the anal canal and rectum. Fissure in ano, Fistula in ano and haemorrhoids are among the most common ano-rectal conditions. In these cases, symptoms like pain, itching, burning, bleeding and swelling can significantly affect a patient's lifestyle. In Today's Era, for pain management in post-operative cases of ano-rectal diseases, yoga plays an important role in pain management. Yoga is a way of living that aim towards a healthy mind in a healthy body. \textit{Ashwini mudra} is a tantric practice used to generate and move \textit{prana} (life force energy) upward along the spine, via the main energy channel of the subtle body known as \textit{sushumna nadi}. The practice involves contracting the anal sphincter in a rhythmic way, thereby generating and containing intense energy within the lower body before pumping it upwards As the ano-rectal disease require long term conservative treatment and also surgical intervention. Due to this patients are suffering for long term problems. To minimize the side effects of medicine in post-operative cases, certain measures are needed. Yoga is a way of living that aims towards a healthy mind in a healthy body. \textit{Sushruta} and \textit{Vagbhata} have described that the total length of \textit{Guda} is 4\ensuremath{\frac12}  \textit{Angula} only. \textit{Vagbhata} had also told measurement of \textit{Guda} as \textit{Atmapanitala} (palm of hand) \textit{Ashwini} \textit{mudra} is very easy to perform and can be done during any time and by any age group. 
\end{abstract}\def\keywordstitle{Keywords}

\begin{keywords}Ano-rectal disorders,\newline Sushumna nadi,\newline Ashwini mudra,\newline Vagbhata
\end{keywords}
\twocolumn[ \maketitle {\printKwdAbsBox}]
\makeatletter{\raggedright\textsuperscript{*}Corresponding Author\par Name:\ Kiran~Khandare~\\ Phone:\ 9765033585~\\  Email:\ kbkhandare@gmail.com
        \par}\vspace*{-11pt}\hrulefill\par{\fontsize{12}{14}\selectfont ISSN: 0975-7538}\par% 
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\section{Introduction}
Ano-rectal disorders refer to the illness of the anal canal and rectum. Fissure in ano, fistula in ano and haemorrhoids are among the most common ano-rectal conditions. In these cases, symptoms like pain, itching, burning, bleeding and swelling can significantly affect a patient's lifestyle.  

Ano-rectal symptoms and complaints are common and may be caused by a wide spectrum of conditions. The history, as well as the physical examination, can distinguish anal pain due to haemorrhoids, fissure or abscess. 

The anal canal is the most terminal part of the lower gastrointestinal tract, which lies between the anal verge in the perineum below and the rectum is the lower 10 to 15 cm of the large intestine four to eight anal glands drain into the crypts of Morgagni at the level of the dentate line. The dentate line also delineates where sensory nerve fibres end. Above (proximal to) the dentate line, the rectum is supplied by stretch nerve fibres but not pain nerve fibres. Conversely, below the dentate line, there is extreme sensitivity, and the perianal area is one of the more sensitive areas of the body. The evacuation of bowel contents depends on action by the muscles of both the involuntary internal sphincter and the voluntary external sphincter 

Although the most common ano-rectal disorders are not considered life-threatening, they can negatively impact a patient's activities of daily living and quality of life.  

Ano-rectal diseases require long term conservative treatment and also surgical intervention \unskip~\citep{1080039:22036375}.  Due to this patients are suffering from long term problems. For this purpose, certain measures are required to solve the problems of patients. 

In Today's Era, for pain management in post-operative cases of ano-rectal diseases, yoga plays an important role in pain management. Yoga is a way of living that aims towards a healthy mind in a healthy body\textit{. Ashwini mudra} is a tantric practice used to generate and move \textit{prana} (life force energy) upward along the spine, via the main energy channel of the subtle body known as \textit{sushumna nadi.}

The practice involves contracting the anal sphincter in a rhythmic way, thereby generating and containing intense energy within the lower body before pumping it upwards \unskip~\citep{1080039:22036361}. Yoga is a way of living that aims towards a healthy mind in a healthy body \unskip~\citep{1080039:22036364}.  

\textit{Sushruta} and \textit{Vagbhata} have described that the total length of Guda is 4\ensuremath{\frac12}  \textit{Angula} only. \textit{Vagbhata} had also told measurement of \textit{Guda} as \textit{Atmapanitala} (palm of hand) \unskip~\citep{1080039:22036365}. Therefore present study will be conducted to evaluate the effect of \textit{Ashwini mudra} in post operated cases of common ano-rectal diseases.
    
\section{Methodology}
\textbf{Trial design}

Observational study

\textbf{Study setting}

Diagnosed Patients will be selected from \textit{Shalyatantra} OPD \& IPD of M.G.A.C.H. and R.C. Wardha. Figure~\ref{f-fe7af74d65af} as shows, 


\bgroup
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\centering \makeatletter\IfFileExists{images/7aa3ff66-2cb4-4ec8-bf2d-16d0327afe98-upicture1.png}{\includegraphics{images/7aa3ff66-2cb4-4ec8-bf2d-16d0327afe98-upicture1.png}}{}
\makeatother 
\caption{\boldmath {Flow diagram of the study procedure}}
\label{f-fe7af74d65af}
\end{figure*}
\egroup
\textbf{Inclusion Criteria}

1. Post-operative cases of ano-rectal diseases of haemorrhoids, Fissure in ano and Fistula in ano.

2. Age group from 18 to 70 yrs of either sex.

 3. Irrespective of economic status, religion and caste.

\textbf{Exclusion Criterion} \textbf{\space }

1. Other than post-operative Ano-rectal cases except for Haemorrhoids, Fissure in ano, Fistula in ano.

\textbf{Criteria for discontinuing or modifying allocated interventions}

Patients will be withdrawal from intervention if any harmful incidence, any problem will occur; a patient will be offered treatment free of cost till the disease subsided.

\textbf{Follow up period after treatment.}

20\ensuremath{^{th }}day after treatment.

\textbf{Primary Outcomes}

To study the effect of \textit{Ashwini Mudra} on pain in post-operative ano-rectal cases. 

\textbf{Secondary Outcomes}

To study the effect of \textit{Ashwini Mudra} on bleeding in post-operative ano-rectal cases.

\textbf{Statistical analysis}

Statistical analysis will be done on the basis of observations.

\textbf{Time duration till follow up}

All the subjects will call for follow on the 2\ensuremath{^{nd}}, 4\ensuremath{^{th}}, 6\ensuremath{^{th}} \& 10\ensuremath{^{th}} Day. Assessment in follow up will be on the basis of pain and bleeding.

\textbf{Time schedule of enrolment, interventions}

Post-operative cases of common Ano-rectal diseases. Ano-rectal diseases includes-


  
  \begin{enumerate}
  \item \relax Haemorrhoids
  \item \relax Fissure in ano
  \item \relax Fistula in ano
  \end{enumerate}
  \textbf{Interventions}


  
  \begin{enumerate}
  \item \relax Explanation to a patient about Ashwini Mudra
  \item \relax Assessment of the effect of Ashwini Mudra in post-operative cases with a hot sitz bath.
  \item \relax Statistical analysis from data collection.
  \end{enumerate}
  \textbf{Groups - 2 }

Groups each with a minimum15 of patients fulfilling the inclusion criteria will be selected for this study. Table~\ref{tw-e096a63fbc35} as shows,


\bgroup
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\centering \makeatletter\IfFileExists{images/a71b69d4-e2a3-4816-9dd2-319ba3860663-upicture2.png}{\includegraphics{images/a71b69d4-e2a3-4816-9dd2-319ba3860663-upicture2.png}}{}
\makeatother 
\caption{\boldmath {Visual Analog Scale (VAS) Faces Pain Scale}}
\label{f-c5367cad1cc8}
\end{figure*}
\egroup

\begin{table}[!htbp]
\caption{\boldmath {Sample size in two research groups} }
\label{tw-e096a63fbc35}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.27819999999999997\linewidth-2\tabcolsep}p{\dimexpr.4710000000000001\linewidth-2\tabcolsep}p{\dimexpr.25080000000000002\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}Group & Group A & Group B\\
\tblmidrule 
\multicolumn{1}{p{\dimexpr(.27819999999999997\linewidth-2\tabcolsep)}}{\multirow{2}{\linewidth}{Sample Size}} &
  15 &
  15\\
 &
  Ashwini Mudra with a hot water sitz bath  &
   Hot water sitz bath\\
\tblbottomrule 
\end{tabulary}\par 
\end{table}

\begin{table}[!htbp]
\caption{\boldmath {Bleeding assessment} }
\label{tw-c6f9bfddeb54}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.5332\linewidth-2\tabcolsep}p{\dimexpr.4667999999999999\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor} Assessment criteria &  Grade\\
\tblmidrule 
No Bleeding &
   0\\
Bleeding &
   1\\
\tblbottomrule 
\end{tabulary}\par 
\end{table}

\bgroup
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\centering \makeatletter\IfFileExists{images/2372297f-438a-4306-8fe7-48c6971eb2b7-upicture3.png}{\includegraphics{images/2372297f-438a-4306-8fe7-48c6971eb2b7-upicture3.png}}{}
\makeatother 
\caption{\boldmath {Gantt Chart (Quarterly based) of research}}
\label{f-5ce66ef9416f}
\end{figure*}
\egroup
\textbf{Group A}

Patients will be advised to do \textit{Ashwini mudra} with a hot Sitz bath daily for 10 minutes twice a day.

\textbf{Group B}

Patients will be advised to do a hot sitz bath for 10 minutes twice a day.

 Post-operative medicinal treatment will be the same in both groups.

\textbf{Recruitment}

A patient will be recruited by a single-arm study 

\textbf{Implementation}

Principal invigilator will register the subject.

\textbf{Data collection methods}

Randomized

\textbf{Assessment criteria}

\textbf{Pain}

Pain will be assessed according to the standard modality of assessment of pain through a visual analog scale.

Description of VAS: Figure~\ref{f-c5367cad1cc8} can be categorized and graded as below- 

(a) Very happy no pain = 0 grade

(b) Hurts a just little bit =2 grade

(c) Hurts a little more=4 grade 

(d) Hurts even more=6 grade

(e) Hurts a whole lot=8 grade

(f) Hurts as much as you can imagine (don't have to be crying to feel this much pain) =10grade

\textbf{Bleeding}

Bleeding will be assessed on the basis of the presence or absence of per rectal bleeding before or after defecation. Figure~\ref{f-5ce66ef9416f} and Table~\ref{tw-c6f9bfddeb54} as shows,

\textbf{Data management}

The principal investigator will do the coding of data.

\textbf{Ethics and dissemination}

Permission for research has been taken from Institutional Ethical Committee.

\textbf{Consent or assent}

Written informed consent will be obtained from the patient. 

\textbf{Dissemination policy}

For future research, results will be disseminated, and research will be published in a reputed journal. 

\textbf{Informed consent materials}

All the research related document and consent form will be given to the patients.
    
\section{Expected\textbf{\space }Results and Discussion}
In yoga, many modalities have been given, but according to reference, it is found that \textit{Ashwini Mudra} is one of among yoga which is helpful in pain management. \unskip~\citep{1080039:22036363} The practice of Ashwini Mudra provides strength to the puboanalis and puborectalis muscles of the pelvic floor\unskip~\citep{1080039:22036362}. Therefore the present study is conducted to evaluate the effect of \textit{Ashwini mudra} in post operated cases of common ano-rectal diseases. As in most of the postoperative cases, non-steroid anti-inflammatory drugs (NSAID) are prescribed, and it causes peptic ulcer and other complications in patients; therefore, to avoid such complications we need treatment which can be easily practiced and is non-invasive. Discussions will be carried out on the basis of the effect of this yogic exercise with the help of different parameters.
    
\section{Conclusion}
After completion of this intervention, it can be expected that \textit{Ashwini mudra} with a hot sitz bath is more helpful comparing to the hot sitz bath in treating post-operative cases of ano rectal disease. Thus, by virtue of this research work, conclusions will be drawn whether this improved modality is a better modality for the post-operative pain management of ano rectal disease.

\textbf{Ethical clearance}

Taken from Institutional Ethical committee.

\textbf{Conflict of Interest}

The authors declare that they have no conflict of interest for this study.

\textbf{Funding Support}

The authors declare that they have no funding support for this study.\textbf{\space }
    

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