Clinical Efficacy of Shulaghna Saptak Vati in post operative pain management after open Haemorrhoidectomy- A Randomized Controlled Clinical Trial

Arsha is one among the eight grave diseases mentioned in Susruta Samhita. It can be compared with hemorrhoids in Western system of medicine. At least 50% of people over the age of 50 years have some degree of symptom of hemorrhoid. Open Haemorrhoidectomy (Milligan Morgan) is one among the treatments of choice in 3rd and 4th degree hemorrhoids. However it is associated with significant amount of post operative pain, which may increase the patient sufferings and can lead to post operative adverse events such as urine retention. Diclofenac analgesics are commonly used to treat post operative pain. These conventional analgesics and anti-inflammatory drugs have been known of producing a wide range of adverse effects. Hence there is an urgent need for research into novel analgesics that are both safe and efficacious, with acceptable tolerability and demonstrated efficacy.  Shulaghna Saptaka Vati is a polyherbal formulation which is having proven analgesic and anti-inflammatory in animal models. This formulation contains various chemical constituents such as B-boswellic acid, Glycerrhizine, Flavonoids, Tinosporin, Saponins etc. which can act in both peripheral and central analgesic mechanism. Data regarding the oral acute toxicity studies are also carried out in animals. Till date no human clinical research works on pain management potential of Shulaghna Saptaka Vati are available. Thus, this drug has been selected in comparison with the most commonly used diclofenac analgesics in post operative pain management of open hemorrhoidectomy.40 post operative cases of open hemorrhoidectomy willbe selected irrespective of the sex, religion, caste, occupation etc. from IPDof hospital I.T.R.A., Jamnagar. The selected patients will be divided intofollowing two groups by computer generated randomized method (Graph pad).

GROUP-A (Trial group):

•       Shulaghna Saptak Vati (500mg) 2 tablets thrice dailywith lukewarm water after food for initial 7 post operative days after openHemorrhoidectomy

In GROUP-B (Controlled group)

·       TabDiclofenac sodium 50mg one tablet twice daily with water, after food forinitial 7 post operative days after open Hemorrhoidectomy.

Observations will be recordedsystematically using a structured proforma .Statistical analysis will be donein order to evaluate and compare the effect of of Shulghna Saptak Vati and Tab Diclofenac in postoperative pain management after hemorrhoidectomy. Diclofenac analgesics arecommonly used to treat post operative pain. These conventional analgesics andanti-inflammatory drugs have been known of producing a wide range of adverseeffects. Hence there is an urgent need for research into novel analgesics thatare both safe and efficacious, with acceptable tolerability and demonstratedefficacy.