Ayurvedic treatment of Piles

• Conditions: Second degree hemorrhoids. Ayurveda Condition: ARSHA, (2) ICD-10 Condition: K642||Third degree hemorrhoids. Ayurveda Condition: ARSHA,

• Registration Number: CTRI/2021/01/030406
• Lead Sponsor: Dr Maheshkumar S Gujar

Brief Summary

The earliest references of *Arsha* areavailable sincevedicperiod.*Durnama* was the wordused for the *Arsha* *in* *Rigveda* and *Atharvaveda*. The reference of the *oushadhidravya*fortreating *Arsha* is mentioned in *ShuklaYajurveda*. Among the *Bruhatrayis* *Sushruta* and *Vagbhata* mentions it under*Astamahagada*.This shows thegravity of this disease. According to *Ayurveda* the disease comesunder the headingof *Mahagadas* (Su. Su. 33/4) asit is: *Dirghakalanubandhi*, *Dushchikitsya* in nature,*Tridoshaja* and involves the *Marma*. *Arsha* occurs in *Gudabhaga*, which isundoubtedly a *Marma*, and it is well known for its chronicityand difficult to treat. Haemorrhoidis a disease, which is very specific to human beings because of his erectposture. InProctology the most common disease is *Arsha.* The majority ofthe Ano rectal diseases by nature are very troublesome. The reasonsbeing the part is always subjected to natural stress and strain,exposed to faecal contamination and difficulty in maintaining local hygiene. Arsha is a disease inwhich unrestrained persons when indulges in nidana there is vitiation ofdoshasleadingto agnimandhyawhichhampers the functions of *apana vata*leadingto mala*vibhadata*. Due to prolongedcontact of accumulated *mala*, with *gudavali*leadsto the appearance of *mamsa prarohas* or *Arshas*. Arsha can be clinicallycorrelated with haemorrhoidswhich can affect anyone. It is one of the commonest problems of anorectalregion 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 ageof 50 yearshave some degree of symptoms of haemorrhoid, but with due consideration ofother causativefactors, it has become difficult to ascertain the impact of ageing factor onthe entity. Itis certainly one of the commonest ailments that affect the mankind.

Even the WHO has started celebrating the 20thNovember of every year as “WORLD PILES DAY†which clearly indicates the prevalence of this disease all over theworld 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 ofcases. But it cannot be accurately applied to all the conditions diagnosed as haemorrhoids; for amost of them do not have bleeding. The term ‘pile’ on the other hand, derived from the Latinword pila - a ball, can be aptly used for all forms of Haemorrhoid or piles. Haemorrhoid is dealt rationally under the concept of *Arsha Chikitsa* inthe *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* (Palliativetreatment) (ii) *Kshara Karma* (Potential cauterization agent therapy) (iii) *Agnikarma* (Directcauterization agent therapy) and (iv) *Shastra Karma* (Operation by sharp instrument). The above saidmeasures have been indicated in the order of treatment for *Arsha*. *Kshara Karma* hasbeen identified along with *Agnikarma* as the parasurgical measures having minimal invasiveprocedures. These procedures have many advantages like-simple, safe, effective, ambulatory andknown for minimal or no complications, less time to stay in the hospital and minimaldisturbance in patient’s routine work and even cost effective. That’s why it is readily acceptableto patient. As far as modern modalities of treatment are concerned, the conservativetreatment of haemorrhoids consist, use of laxative and high residual diet. But there arelimitations and no radical cure by medicines as the mass is formed enough which needs somesurgical intervention for radical cure. Surgical intervention method includesSclerotherapy, Rubber Band ligation, Infrared photocoagulation, Laser therapy, Lord’s analdilatation, 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 newermethods. Several new surgical methods have led to a reconsideration of haemorrhoid disease over thelast few decades.Despite a range of treatment modalities, the options are limited to their effectiveness. There are still existed controversies and lack of agreement inregards to the treatment strategies for haemorrhoids. The modern surgery has made rapidprogress as in the present era no organ or the tissue is spared from surgical approach. In spiteof such progress the surgical procedures in Anorectal diseases are not so encouraging. Thesurgery 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 atreatment modality, which would ideally offer the cure of the disease in shorter time, free fromcomplications and economically better. In *Astavidhashastrakarmeeyaadhyaya, Sushruta* has mentioned *chedana* and*lekhana karma* for *Arshas.* And effect of *Kshara* replaces *Shastrakarma* as it does the *chedana, bhedana* and *lekhana karma*. *Apamarga* is one among the *vanaspatyadravya* which is easily available, mentioned in *Kshara kalpa vidhi adhyaya* of *SushrutaSamhita* 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 anideal option.

The *Ksharasutra* therapy in the management of *Arsha* isproved to be the promising treatment modality, but still the post operativecomplications like irritation to the patient, healing of the wound, foul smell,feeling of the painful mass because of reactionary oedema, necrosis of the mass,convalescenceperiod,  etcwill  be the troublesome complications ofthe *Ksharasutra* transfixation in Haemorrhoids. To overcome these lacunasthere is a need for the further study to incorporate the *standard operatingprocedure*, or *SOP* (step-by-step instructions)to help the surgeons carry out operations. Hence in the present study an attempthas been made to standerdise the operative procedure of *Ksharasutra*ligation with partial excision of the pile mass and without partial excision onthe pile mass. The partial excision of the pile mass may definitely vanish theabove said lacunas of the *Ksharasutra* transfixation, as the excision ofthe mass may reduce the irritartion due to the presence of the mass as we areexcision the pile mass partially after transfixation, early wound healing maybe seen , as there will be the cut off of the pile mass which will reduce thefibrotic and necrotic phase before self fall of the pile mass  and the post operative  pain can be minimized as there will be notension in the pile mass which will not cause the endartritis and reduce thepain immediately, after all these the convalescence period can be effectivelyreduced. Hence the present study as been taken up to clinically evaluate theksharasutra therapy with and without partial excision in the management of *Arsha*s w.s.r. to 2ndand 3rd degree internal haemorrhoids.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-13
• Last Update Posted: 2022-07-14

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with clinical features of internal haemorrhoid namely mass per anum, bleeding per anum , pruritis ani, mucoid discharge.
• Patients with single pile mass of 2nd or 3rd degree.

Exclusion Criteria

• Patients below the age of 16 yrs and above 60 yrs.
• Associated with any other ano-rectal diseases.
• Thrombosed haemorrhoids.
• Patient suffering from any systemic disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ASSESSMENT CRITERIA:	Duration of 60 days will be fixed in cases where total relief was obtained to observe the possible recurrences. The observations will be recorded in the proforma of case sheet. | The changes in the features will be observed before the treatment, on 4th day, 8th day and on 15th day after the treatment the same shall be recorded in the proforma of case sheet prepared for the study.
1. Bleeding Per Rectum	Duration of 60 days will be fixed in cases where total relief was obtained to observe the possible recurrences. The observations will be recorded in the proforma of case sheet. | The changes in the features will be observed before the treatment, on 4th day, 8th day and on 15th day after the treatment the same shall be recorded in the proforma of case sheet prepared for the study.
B1- Present	Duration of 60 days will be fixed in cases where total relief was obtained to observe the possible recurrences. The observations will be recorded in the proforma of case sheet. | The changes in the features will be observed before the treatment, on 4th day, 8th day and on 15th day after the treatment the same shall be recorded in the proforma of case sheet prepared for the study.
P2 – Moderate	Duration of 60 days will be fixed in cases where total relief was obtained to observe the possible recurrences. The observations will be recorded in the proforma of case sheet. | The changes in the features will be observed before the treatment, on 4th day, 8th day and on 15th day after the treatment the same shall be recorded in the proforma of case sheet prepared for the study.
P1 – Mild	Duration of 60 days will be fixed in cases where total relief was obtained to observe the possible recurrences. The observations will be recorded in the proforma of case sheet. | The changes in the features will be observed before the treatment, on 4th day, 8th day and on 15th day after the treatment the same shall be recorded in the proforma of case sheet prepared for the study.
3. Pruritis ani	Duration of 60 days will be fixed in cases where total relief was obtained to observe the possible recurrences. The observations will be recorded in the proforma of case sheet. | The changes in the features will be observed before the treatment, on 4th day, 8th day and on 15th day after the treatment the same shall be recorded in the proforma of case sheet prepared for the study.
P-presence of itching.	Duration of 60 days will be fixed in cases where total relief was obtained to observe the possible recurrences. The observations will be recorded in the proforma of case sheet. | The changes in the features will be observed before the treatment, on 4th day, 8th day and on 15th day after the treatment the same shall be recorded in the proforma of case sheet prepared for the study.
Objective parameters:	Duration of 60 days will be fixed in cases where total relief was obtained to observe the possible recurrences. The observations will be recorded in the proforma of case sheet. | The changes in the features will be observed before the treatment, on 4th day, 8th day and on 15th day after the treatment the same shall be recorded in the proforma of case sheet prepared for the study.
P0 – Absent	Duration of 60 days will be fixed in cases where total relief was obtained to observe the possible recurrences. The observations will be recorded in the proforma of case sheet. | The changes in the features will be observed before the treatment, on 4th day, 8th day and on 15th day after the treatment the same shall be recorded in the proforma of case sheet prepared for the study.
1. Mucoid discharge	Duration of 60 days will be fixed in cases where total relief was obtained to observe the possible recurrences. The observations will be recorded in the proforma of case sheet. | The changes in the features will be observed before the treatment, on 4th day, 8th day and on 15th day after the treatment the same shall be recorded in the proforma of case sheet prepared for the study.
N- Absent	Duration of 60 days will be fixed in cases where total relief was obtained to observe the possible recurrences. The observations will be recorded in the proforma of case sheet. | The changes in the features will be observed before the treatment, on 4th day, 8th day and on 15th day after the treatment the same shall be recorded in the proforma of case sheet prepared for the study.
2. Fall of pile mass	Duration of 60 days will be fixed in cases where total relief was obtained to observe the possible recurrences. The observations will be recorded in the proforma of case sheet. | The changes in the features will be observed before the treatment, on 4th day, 8th day and on 15th day after the treatment the same shall be recorded in the proforma of case sheet prepared for the study.
Duration was considered in terms of days.	Duration of 60 days will be fixed in cases where total relief was obtained to observe the possible recurrences. The observations will be recorded in the proforma of case sheet. | The changes in the features will be observed before the treatment, on 4th day, 8th day and on 15th day after the treatment the same shall be recorded in the proforma of case sheet prepared for the study.
2. Pain	Duration of 60 days will be fixed in cases where total relief was obtained to observe the possible recurrences. The observations will be recorded in the proforma of case sheet. | The changes in the features will be observed before the treatment, on 4th day, 8th day and on 15th day after the treatment the same shall be recorded in the proforma of case sheet prepared for the study.
B0- Absent	Duration of 60 days will be fixed in cases where total relief was obtained to observe the possible recurrences. The observations will be recorded in the proforma of case sheet. | The changes in the features will be observed before the treatment, on 4th day, 8th day and on 15th day after the treatment the same shall be recorded in the proforma of case sheet prepared for the study.
A-absence of itching.	Duration of 60 days will be fixed in cases where total relief was obtained to observe the possible recurrences. The observations will be recorded in the proforma of case sheet. | The changes in the features will be observed before the treatment, on 4th day, 8th day and on 15th day after the treatment the same shall be recorded in the proforma of case sheet prepared for the study.
Y- Present	Duration of 60 days will be fixed in cases where total relief was obtained to observe the possible recurrences. The observations will be recorded in the proforma of case sheet. | The changes in the features will be observed before the treatment, on 4th day, 8th day and on 15th day after the treatment the same shall be recorded in the proforma of case sheet prepared for the study.
P3 – Severe	Duration of 60 days will be fixed in cases where total relief was obtained to observe the possible recurrences. The observations will be recorded in the proforma of case sheet. | The changes in the features will be observed before the treatment, on 4th day, 8th day and on 15th day after the treatment the same shall be recorded in the proforma of case sheet prepared for the study.

Secondary Outcome Measures

Name	Time	Method
Incidence of the Patients with 2nd and 3rd degree internal haemorrhoids in the OPD and IPD section at SRHI J G COOPERATIVE HOSPITAL SOCIETYS AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE will be Discussed with the points related with the Age, Sex, Occupation, Diet, etc.	Duration of 60 days will be fixed in cases where total relief was obtained to observe the possible recurrences. The observations will berecorded in the proforma of case sheet.

Trial Locations

Locations (1)

SRHI J G COOPERATIVE HOSPITAL SOCIETYS AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE; 🇮🇳 Belgaum, KARNATAKA, India

SRHI J G COOPERATIVE HOSPITAL SOCIETYS AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE

🇮🇳Belgaum, KARNATAKA, India

Dr MAHESHKUMAR S GUJAR

Principal investigator

9538140510

msgujar04@gmail.com