1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Researchers who provide a methodologically sound proposal.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Data are available indefinitely at (Link to be included www.giafsayurvedaashraya.com/blog).
   


6. For how long will this data be available start date provided 14-02-2021 and end date provided 14-02-2024?
   Response - Beginning 9 months and ending 36 months following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - www.giafsayurvedaashraya.com/blog

The earliest references of Arsha are available since vedic period. Durnama was the word used for the Arsha in Rigveda and Atharvaveda.  The reference of the oushadhi dravya for treating Arsha is mentioned in Shukla Yajurveda. Among the Bruhatrayis Sushruta and Vagbhata mentions it under Astamahagada.This shows the gravity of this disease. According to Ayurveda the disease comes under the heading of Mahagadas (Su. Su. 33/4) as it is: Dirghakalanubandhi, Dushchikitsya in nature, Tridoshaja and involves the Marma. Arsha occurs in Gudabhaga, which is undoubtedly a Marma, and it is well known for its chronicity and difficult to treat.
Haemorrhoid is a disease, which is very specific to human beings because of his erect posture. In Proctology the most common disease is Arsha. The majority of the Ano rectal diseases by nature are very troublesome. The reasons being the part is always subjected to natural stress and strain, exposed to faecal contamination and difficulty in maintaining local hygiene.
Arsha is a disease in which unrestrained persons when indulges in nidana there is
vitiation of doshas leading to agnimandhya which hampers the functions of apana vata
leading to mala vibhadata. Due to prolonged contact of accumulated mala, with gudavali
leads to the appearance of mamsa prarohas or Arshas. Arsha can be clinically correlated
with haemorrhoids which can affect anyone. It is one of the commonest problems of anorectal region and reasons may be different like hereditary, anatomical deformities, diet, life
style etc. Its incidence increases with advancing age, at least 50% of people over the age of
50 years have some degree of symptoms of haemorrhoid, but with due consideration of other
causative factors, it has become difficult to ascertain the impact of ageing factor on the
entity. It is certainly one of the commonest ailments that affect the mankind.

Even the WHO has started celebrating the 20th November of every year as “WORLD
PILES DAY” which clearly indicates the prevalence of this disease all over the world and
tremendous physical and mental agony as result of this disease.
The term Haemorrhoid’s and pile’s are used quite interchangeably, but
etymologically the words have entirely different meanings. The term “Haemorrhoid” is
derived from the Greek adjective Haemorrhoid, meaning bleeding (haema - blood, rhoosflowing) and emphasizes the most prominent symptom in the majority of cases. But it cannot
be accurately applied to all the conditions diagnosed as haemorrhoids; for a most of them do
not have bleeding. The term ‘pile’ on the other hand, derived from the Latin word pila - a
ball, can be aptly used for all forms of Haemorrhoid or piles.
Haemorrhoid is dealt rationally under the concept of Arsha Chikitsa in the Ayurvedic
literatures, however it includes some other fleshy masses like polyp, warts, sentinel tags,
hypertrophied papillae under this treatment. In regards to Arshas management, Sushruta
states four modalities that is (i) Bheshaja Chikitsa (Palliative treatment) (ii) Kshara Karma
(Potential cauterization agent therapy) (iii) Agnikarma (Direct cauterization agent therapy)
and (iv) Shastra Karma (Operation by sharp instrument). The above said measures have been
indicated in the order of treatment for Arsha. Kshara Karma has been identified along with
Agnikarma as the parasurgical measures having minimal invasive procedures. These
procedures have many advantages like-simple, safe, effective, ambulatory and known for
minimal or no complications, less time to stay in the hospital and minimal disturbance in
patient’s routine work and even cost effective. That’s why it is readily acceptable to patient.
As far as modern modalities of treatment are concerned, the conservative treatment
of haemorrhoids consist, use of laxative and high residual diet. But there are limitations and no
radical cure by medicines as the mass is formed enough which needs some surgical
intervention for radical cure. Surgical intervention method includes Sclerotherapy, Rubber
Band ligation, Infrared photocoagulation, Laser therapy, Lord’s anal dilatation,
Haemorrhoidectomy, Cryo surgery, Transanal haemorrhoidal artery ligation, DGHAL
(Doppler Guided Haemorrhoidal Artery Ligation) and Stapled haemorrhoidectomy, which
are in practice.
All these procedures have their own limitations with the complications,
recurrence and for these reasons there is a continuous search for newer methods. Several new
surgical methods have led to a reconsideration of haemorrhoid disease over the last few
decades. Despite a range of treatment modalities, the options are limited to their
effectiveness. There are still existed controversies and lack of agreement in regards to the
treatment strategies for haemorrhoids. The modern surgery has made rapid progress as in the
present era no organ or the tissue is spared from surgical approach. In spite of such progress
the surgical procedures in Anorectal diseases are not so encouraging. The surgery in these
diseases invariably leads to immediate or delayed complications, as well as, chances of high
incidence of relapse of the diseases. Hence, it leaves a scope to find out a treatment modality,
which would ideally offer the cure of the disease in shorter time, free from complications and
economically better.
In Astavidhashastrakarmeeyaadhyaya, Sushruta has mentioned chedana and lekhana
karma for Arshas. And effect of Kshara replaces Shastra karma as it does the chedana,
bhedana and lekhana karma. Apamarga is one among the vanaspatya dravya which is easily
available, mentioned in Kshara kalpa vidhi adhyaya of Sushruta Samhita is used as standard kashra for the management of Arsha and to overcome the lacunas mentioned in the Allopathic system of medicine, management of Arshas by Kshara treatment was considered as an ideal option.

          The Ksharasutra therapy in the management of Arsha is proved to be the promising treatment modality, but still the post operative complications like irritation to the patient, healing of the wound, foul smell, feeling of the painful mass because of reactionary oedema, necrosis of the mass, convalescence period,  etc will  be the troublesome complications of the Ksharasutra transfixation in Haemorrhoids. To overcome these lacunas there is a need for the further study to incorporate the standard operating procedure, or SOP (step-by-step instructions) to help the surgeons carry out operations. Hence in the present study an attempt has been made to standerdise the operative procedure of Ksharasutra ligation with partial excision of the pile mass and without partial excision on the pile mass. The partial excision of the pile mass may definitely vanish the above said lacunas of the Ksharasutra transfixation, as the excision of the mass may reduce the irritartion due to the presence of the mass as we are excision the pile mass partially after transfixation, early wound healing may be seen , as there will be the cut off of the pile mass which will reduce the fibrotic and necrotic phase before self fall of the pile mass  and the post operative  pain can be minimized as there will be no tension in the pile mass which will not cause the endartritis and reduce the pain immediately, after all these the convalescence period can be effectively reduced. Hence the present study as been taken up to clinically evaluate the ksharasutra therapy with and without partial excision in the management of Arshas w.s.r. to 2^nd and 3^rd degree internal haemorrhoids.