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\begin{document}


\def\RunningAuthor{Harjodh Singh and Sonali Chalakh}
\firstPage{1485}
\articleType{Short Communication}
\receivedDate{01 Aug 2020}
\acceptedDate{02 Sep 2020}
\revisedDate{01 Sep 2020}
\journalVolume{2020, 11 (SPL4)}
\journalDoi{ijrps.v11iSPL4.4327}
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\title{\textbf{Application of \textit{Gunja} (\textit{Abrus precatorius} Linn.) \textit{Beeja lepa}: An Ayurvedic protocol for the treatment of G\textit{ridhrasi }(sciatica)}}
\author{Harjodh~Singh\textsuperscript{*}, 
            Sonali~Chalakh~\\[5pt]{Department of Agadtantra, Mahatma Gandhi Ayurved College, Hospital \& Research Centre, Salod (H), Datta Meghe Institute of Medical Sciences, Wardha - 442001, Maharashtra, India}}

\begin{abstract}
The most common musculoskeletal disorder affecting the movement of legs is low back pain. Among the affected patients, 40\% have ridiculer pain, and these cases can be classified under the umbrella of the sciatic syndrome. Low back pain is extraordinarily common, frequently resulting from degenerative arthritis of the lumbosacral spine. The annual prevalence of disc-related sciatica in the general population is estimated at 2.2\%. Sciatica is characterised by constant aching pain which felt in the lumbar region may radiate to the buttock, thigh, calf and foot.\textit{ Acharaya Charaka} explained \textit{Gridhrasi} in eighty types of \textit{nanatmaja Vata vikara}. The present study is aimed at evaluating the effect of \textit{Gunja } (\textit{Abrus precatorius} Linn.) \textit{Beeja lepa } in the management of G\textit{ridhrasi } (Sciatica) and thereby assessing the changes in quality life. The present study is designed as a Non-randomized controlled clinical study, in which a minimum of 30 patients will be enrolled. \textit{Gunja beej lepa } will be administered external application two times in a day with lukewarm water. Assessment will be recorded on the 3\ensuremath{^{rd}}, 5\ensuremath{^{th}}, 7\ensuremath{^{th}}, 14\ensuremath{^{th}} and 28\ensuremath{^{th}} day. Changes will be observed in subjective parameters such as \textit{Ruk }(pain) \textit{Toda} (pin pricking sensation) \textit{Stambha }(Stiffness), \textit{Spandana } (Fasciculation) and objective parameters such as measuring the changes in the angle of elevation of the leg by SLR Test, Sciatica Bothersomeness Index and Sciatica Frequency Index before and after the treatment. Suitable conclusion will be drawn post completion of the trial. 
\end{abstract}\def\keywordstitle{Keywords}

\begin{keywords}Gridhrasi,\newline Sciatica,\newline Gunja,\newline Musculoskeletal disorder,\newline Nanatmaja Vata vikara
\end{keywords}
\twocolumn[ \maketitle {\printKwdAbsBox}]
\makeatletter{\raggedright\textsuperscript{*}Corresponding Author\par Name:\ Harjodh~Singh~\\ Phone:\ ~\\  Email:\ harjodhsingh97@gmail.com
        \par}\vspace*{-11pt}\hrulefill\par{\fontsize{12}{14}\selectfont ISSN: 0975-7538}\par% 
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\section{Introduction}
The twenty-first century is the era of lifestyle disorders. The most common musculoskeletal disorder affecting the movement of legs is low back pain. Among the affected patients, 40\% have ridiculer pain, and these cases can be classified under the umbrella of the sciatic syndrome. Low back pain is extraordinarily common, frequently results from degenerative arthritis of lumbosacral spine or disk and commonly follows a dermatomal distribution with the involvement of nerve root between L4 and S3 \unskip~\citep{900960:20480260}. 

Sciatica is characterised by constant aching pain which felt in the lumbar region may(1)dilate to the buttock, thigh, calf and foot \unskip~\citep{900960:20480264}. Sciatic pain radiates alongside the course of the sciatic nerve \unskip~\citep{900960:20480257}. 

It is common between 30-40 yrs of age and affects both the sexes (male and female) equally. About 50\% of working adults experience a back injury each year. The annual incidence of disc-related sciatica in the general population is estimated at 2.2\%\unskip~\citep{900960:20480259}.

In Ayurveda, many \textit{Vata Vvyadhis} are defined which can be categorised as \textit{samanyaja} and \textit{nanatmaja. Acharaya Charaka} defined \textit{Gridhrasi} in eighty types of nanatmaja Vata vikara \unskip~\citep{900960:20480262}. \textit{Gridhrasi}, an entity enumerated by \textit{Shula Pradhana, }which affects the hip and the lower limbs. \textit{Gridhrasi} is a condition characterised by \textit{Ruk }(pain) \textit{Toda} (pin pricking sensation) \textit{Stambha }(Stiffness), \textit{Spandana }(Fasciculation) starting from low back region radiating down to the postero-lateral aspect of the thigh that is \textit{Uru }(thigh), \textit{Janu }(knee), \textit{Jangha }(calf) and\textit{ Pada }(foot) \unskip~\cite{900960:20480263}.

Inflammation of joints and muscles, irritation of the sciatic nerve are the causative factors for the development of sciatica. \textit{Gunja} (\textit{Abrus precatorius}) is one of the poisonous plants which have proven anti-inflammatory activity \unskip~\citep{900960:20480258}. In \textit{Rasatarangini} paste of \textit{Gunja} seeds is advised in sciatica \unskip~\citep{900960:20480261}.
    
\section{Methodology}
\textbf{Study type}

Non\textbf{-}Randomized, single-arm interventional study.

\textbf{Study design}

Diagnosed Patients will be selected from OPD \& IPD of \textit{Panchkarma }department MGACH and RC Wardha. The detailed study design is shown in Figure~\ref{f-4b89c58d3d55} and Table~\ref{tw-299c152bb64e}.


\bgroup
\fixFloatSize{images/a0c4b0ee-eaba-49f5-8259-b3af2ffc2ace-upicture1.png}
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\centering \makeatletter\IfFileExists{images/a0c4b0ee-eaba-49f5-8259-b3af2ffc2ace-upicture1.png}{\includegraphics{images/a0c4b0ee-eaba-49f5-8259-b3af2ffc2ace-upicture1.png}}{}
\makeatother 
\caption{\boldmath {Flow diagram of the study procedure}}
\label{f-4b89c58d3d55}
\end{figure*}
\egroup
\textbf{Schedule of enrollment, interventions}

Diagnosed patients of G\textit{ridhrasi } (Sciatica) will be enrolled in the present study after fulfilling the inclusion criteria.

\textbf{Interventions}

Local application of \textit{Gunja} \textit{Beeja lepa} will be done for twice a day over sciatic notch for seven days. Sample size-30. Data collection methods- Non- Randomized. Time duration until the follow-up - The follow-up period will be 28 days. During treatment - 3\ensuremath{^{rd}}, 5\ensuremath{^{th}}, \& 7\ensuremath{^{th}} day. After treatment - 14\ensuremath{^{th }}\& 28\ensuremath{^{th}} day. 

\textbf{Registration Number}

Study will be conducted with CTRI Number- CTRI/2019/08/020985 and IEC Reference No- DMIMS (DU)/IEC/2017-18/7260. 

\textbf{Inclusion Criterion}


  
  \begin{enumerate}
  \item \relax Patients diagnosed as the case of Gridhrasi (Sciatica) with the presenting symptoms of either sex.
  \item \relax Patients in the age group 30 to 50 years of age.
  \item \relax Patients with straight-leg raising (SLR) test (0-60 Degree) positive.
  \end{enumerate}
  \textbf{Exclusion Criterion}


  
  \begin{enumerate}
  \item \relax Patients with Sensitivity test positive.
  \item \relax Monoplegia, paraplegia, hip joint arthritis, TB of the spine, severe accidental cases and other surgical emergencies.
  \item \relax Pregnant and lactating women.
  \item \relax Patients with skin diseases or lesions. 
  \end{enumerate}
  \textbf{Criteria for discontinuing or modifying allocated interventions}

If any undesired incidence occurs then the patient will be withdrawn from the study and free of cost treatment will be provided to the patient till the disease subsides. 

\textbf{Primary Outcomes}

Changes in the symptoms of \textit{Gridhrasi such as } \textit{Ruk }(pain), \textit{Toda} (pin pricking sensation), \textit{Stambha }(Stiffness), \textit{Spandana } (Fasciculation).

\textbf{Secondary Outcomes}

To observe the changes in the angle of elevation of the leg by SLR Test and changes in the Sciatica Bothersomeness Index and Sciatica Frequency Index before and after the treatment.

\textbf{Statistical analysis}

Wilcoxon signed-rank and paired t-test will be done to analyse the data. Follow up will be on 3\ensuremath{^{rd}}, 5\ensuremath{^{th}}, 7\ensuremath{^{th}}, 14\ensuremath{^{th.}}

\textbf{Recruitment and Implementation}

The patients will be enrolled and allocated by Principal invigilator.

\textbf{Assessment criteria}

The subjective criteria for assessment are \textit{Ruk }(pain), \textit{Stambha } (Stiffness),\textit{ Toda }(Pin pricking sensation), \textit{Spandana }(Fasciculation). Straight Raise Leg Test, sciatica Frequency Index and Sciatica Bothersome index are objective parameters (Table~\ref{tw-30dac41f4115}).


\begin{table*}[!htbp]
\caption{\boldmath {Assessment criteria} }
\label{tw-30dac41f4115}
\centering 
\begin{threeparttable}

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\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack Parameter  & \cAlignHack Grade 0 & \cAlignHack Grade 1 & \cAlignHack Grade 2 & \cAlignHack Grade 3  & \cAlignHack Grade 4\\
\tblmidrule 
Ruk &
  No pain &
  Painful walks without limping &
  Painful walks with limping but without support &
  Painful, can walk only with the support &
  Painful, unable to walk\\
Toda  &
  Absent &
  Present &
  \cAlignHack - &
  \cAlignHack - &
  \cAlignHack -\\
Stambha  &
  Absent &
  Present &
  \cAlignHack - &
  \cAlignHack - &
  \cAlignHack -\\
Spandana  &
  Absent &
  Present &
  \cAlignHack - &
  \cAlignHack - &
  \cAlignHack -\\
S.L.R.T.* &
  More than 90 degree &
  71-90 degree &
  51-70 degree &
  31-50 degree &
  Up to 30 degree\\
\tblbottomrule 
\end{tabulary}\par 
\begin{tablenotes}\footnotesize 
    
\item{* SLRT - Straight Raise Leg Test}
\end{tablenotes}
\end{threeparttable}

\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Gnatt Chart (Quarterly based)} }
\label{tw-299c152bb64e}
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\tbltoprule \rowcolor{kwdboxcolor} & \cAlignHack Q1 & \cAlignHack Q2 & \cAlignHack Q3 & \cAlignHack Q4 & \cAlignHack Q5 & \cAlignHack Q6 & \cAlignHack Q7 & \cAlignHack Q8\\
\tblmidrule 
Enrolment of Volunteer &
  \cAlignHack X &
  \cAlignHack X &
  \cAlignHack X &
  \cAlignHack X &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack \\
Data collection &
  \cAlignHack X &
  \cAlignHack X &
  \cAlignHack X &
  \cAlignHack X &
  \cAlignHack X &
  \cAlignHack X &
  \cAlignHack  &
  \cAlignHack \\
Data collection &
  \cAlignHack  &
  \cAlignHack X &
  \cAlignHack X &
  \cAlignHack X &
  \cAlignHack X &
  \cAlignHack X &
  \cAlignHack  &
  \cAlignHack \\
Data analysis &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack X &
  \cAlignHack X &
  \cAlignHack X &
  \cAlignHack \\
Writing a thesis up to results and Conclusions &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack X &
  \cAlignHack X\\
Submission &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack X\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}
\textbf{Data management}

The data entry coding will be done by PI.

\textbf{PI will do the data entry coding dissemination}

Permission for research has been taken from Institutional Ethical Committee ref no DMIMS (DU)/IEC/2017-18/7260

\textbf{Informed consent or assent}

All the research related documents and consent form will be given to the patients. The confidentiality of patients will be maintained during the study. 

\textbf{Dissemination policy}

In future data will be disseminated for clinical work and publication.

\textbf{Informed consent materials}

Consent form and other related documentation will be given to participants and authorised informants with all the information.\textbf{\space }
    
\section{Discussion}
The main causative factor for the pathogenesis of sciatica is inflammation which leads to the presentation of pain and other symptoms. In Ayurveda, \textit{Gunja Beeja lepa} is used for the management of \textit{kandu}, \textit{kustha}, \textit{darunaka}, many skin diseases and various arthritic conditions like a\textit{amvata.}  \textit{Gunja} seeds are \textit{tikta} (Bitter) and \textit{kashaya} (Astringent) rasa and \textit{katu} (Pungent) \textit{vipaka} due to which \textit{Gunja lepa} may act as a potent \textit{Vata kaphahara, Shothahara, Vedna shamak}.
    
\section{Conclusion}
\textit{Gunja} (\textit{Abrus precatorius}) is a plant which has proven anti-inflammatory activity. This study will demonstrate treatment modalities of \textit{Ayurved}, wherein the efficacy of \textit{gunja Beeja lepa} will be studied in the management of G\textit{ridhrasi }(sciatica).
\section*{Acknowledgement}We would like to thank the supporting staff of Department of \textit{Agadtantra}, MGACH \& RC for the co-operation during this case study.

\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.
    

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