Clinical evaluation of Efficacy and Safety of investigation product (HF-PRT01) in the patient of hemorrhoids an observational study.

Haemorrhoids are cushions of submucosal vascular tissue located in the anal canal starting just distal to the dentate line. Incidence is difficult to ascertain as many people with the condition will never consult with a medical practitioner, although one study found 10 million people in the USA complaining of the disease.1 The exact cause of symptomatic haemorrhoids is unknown. Many factors are believed to play a role, including irregular bowel habits (constipation or diarrhoea), lack of exercise, nutritional factors (low-fiber diets), increased intra-abdominal pressure (prolonged straining, ascites, an intra-abdominal mass, or pregnancy), genetics, an absence of valves within the haemorrhoidal veins, and aging. Other factors believed to increase risk include obesity, prolonged sitting, a chronic cough, and pelvic floor dysfunction. Evidence for these associations, however, is poor. Little is known about the association of haemorrhoids and anorectal function. Moreover, available data on the impact of constipation on the presence of haemorrhoids are conflicting. A study in population has found significant association between constipation and haemorrhoids in adult patients.2

Haemorrhoids may occur inside the anus (internal haemorrhoids) or outside (external haemorrhoids). If both internal and external, they are called mixed haemorrhoids. The main symptoms are swelling, pain, pruritis, discharge of fluid and haemorrhage. Drug treatment for various anorectal conditions has been known since ancient times. Today, modern as well as traditional drugs are being increasingly used in all grades of symptomatic haemorrhoids. These drugs (oral and local) are used as a part of conservative management or as an adjuvant to invasive outpatient procedures. The management of haemorrhoids has evolved rapidly during the past few decades. Several new treatments have been proposed with the aim of reducing patients’ postoperative pain, time to return to normal life, risk of early and late complications, and recurrence rate. Although conservative treatment based on dietary and lifestyle changes can help the majority of patients, and rubber band ligation and phlebotonic drugs can effectively treat grade I and II haemorrhoids, surgery is required for the most advanced stages.

Clinically haemorrhoids are classified according as per International criteria of classification:

·         Grade I: No prolapse, just prominent blood vessels

·         Grade II: Prolapse upon bearing down, but spontaneous reduction

·         Grade III: Prolapse upon bearing down requiring manual reduction

·         Grade IV: Prolapse with inability to be manually reduced. 3

However, management of these piles is not an easy task as most of the patients seek clinical assistance at a later stage, complicating the disease condition. Grades I through III could be effectively managed by medicinal treatment in compliant and non-complicated patients but there appears scarcity of clinically proven formulations for this indication.

HF-PRT01 is such polyherbal formulation indicated to reverse the etiopathology of haemorrhoids by correcting the metabolism, improving liver impairment and alleviating vascular engorgement. The present study is hence proposed to evaluate the effect and safety of Tab Rectafix® in patients with haemorrhoids.