Efficacy of Apamarga Kshara Pratisaran and Cryotherapy in the management of Arsha (Second degree Haemorrhoids) – An open labelled randomized controlled clinical trial

Haemorrhoids are symptomatic enlargements of the internal haemorrhoidal venous plexus. Internal haemorrhoids characteristically lie in the 3, 7 and 11 o’clock positions (with the patient in the lithotomy position). The worldwide prevalence of Haemorrhoids is around 4.4%. The incidence of this disease is showing augmentation with advancing age. At least 50% of the people over the age of 50 years have some degree of symptoms related to hemorrhoids*.*Conservative medical treatment of haemorrhoids includes use of fiber supplements; lifestyle modifications may include relieving constipation, avoiding straining, proper fluid intake, better anal hygiene and sitz baths. If the patients do not respond to conservative measures, rubber band ligation (RBL), sclerotherapy, infrared coagulation (IRC) and cryosurgery are some outpatient department (OPD) procedures. Surgery, i.e. haemorrhoidectomy, for haemorrhoids is indicated in fourth grade when symptoms of bleeding, pain and prolapsed piles compromise the quality of life. Cryotherapy is a type of surgery that involves the use of extreme cold to destroy 1st and 2nd degree haemorrhoids. Arsha (Haemorrhoids) is considered as one among the eight grave diseases (Ashta mahagada) in Ayurvedaby Acharya Sushruta. Detailed explanation of Arsha including etiology, types, clinical features and various treatment options are given in Sushruta samhita and Charak Samhita also. The treatment options given in Samhita are Bheshaja chikitsa (medicine), Ksharakarma (use of Kshara/Ksharasutra), Agnikarma (cauterization) and Shastrakarma(surgery). Kshara is alkaline in nature derived from a combination of various herbs that is applied to the pile mass with the help of a special slit proctoscope. Sushruta had mentioned various drugs including Apamarga for preparing Kshara.He has also mentioned kshara pratisaran method in the management of Arsha. The present study has been planned to evaluate and compare the clinical efficacy ofApamarga Kshara Pratisaranaand Cryotherapyin the management of Arsha (Second degree Haemorrhoids). In this trial, Diagnosed cases of Arsha (Second degree Haemorrhoids) will be selected from OPD and IPD of hospital of I.T.R.A., Jamnagar irrespective of caste, religion, gender and socioeconomic status and will be allocated randomly into two group (minimum 20 in each group). Intervention arm: will be treated by Apamarga Kshara Pratisaranafor 100 matra kaalin single sitting and comparator arm will be treated with Cryotherapy in single sitting. Parameters such as pain, bleeding per rectum, protrusion of pile mass and Constipation will be assessed and marked on specifically designed research proforma. Follow up will be done on 7th,14th and 21st post operative days. In this study, obtained data will be analyzed on the basis of proper logics and reasoning to find out the comparative efficacy of Apamarga Kshara Pratisarana and Cryotherapy in the management of Arsha (Second degree Haemorrhoids) and further conclusions will be derived from the study.