title: Efficacy and safety of a polyherbal formulation in hemorrhoids.
abstract: BACKGROUND
  The medical management of hemorrhoids should include an integrated approach. This integrated approach can be achieved by polyherbal formulations containing anti-inflammatory, styptics, analgesics, and laxative effect which reduce inflammation, pain, and bleeding, and increase gastro-intestinal motility and soften stools. One such polyherbal kit is "Arshkeyt™, a 7 day kit," which consists of oral tablets and powder along with topical cream.
  
  
  OBJECTIVE
  Efficacy and safety of Arshkeyt™, a 7 day kit, a marketed polyherbal formulation was evaluated in comparison with conventional therapy practiced in surgery outpatient departments.
  
  
  METHODS
  Patients (n = 90) with hemorrhoids were randomly allocated to receive either Arshkeyt™ or standard therapy (combination of oral Isabgul powder and 2% lidocaine gel) for 14 days. Assessment on the basis of rectal symptoms and proctoscopic examination was done on day 0, 7, and 14 to derive a "composite score" which ranged from 0 to 25 by a blinded evaluator. The primary endpoint was number of patients achieving composite score 0 at the end of therapy (day 14). Inter-group analysis was done using Chi-square test.
  
  
  RESULTS
  On day 14, the composite score of 0 was achieved in 15 patients of Arshkeyt™ group versus 6 patients receiving standard therapy. The symptoms and signs which showed significant improvement in Arshkeyt™ group compared to standard treatment group were the tenesmus (visual analog score) score (P = 0.047), anal sphincter spasm (P = 0.0495) and a decrease in the grade of hemorrhoids (P = 0.0205) on day 14. Arshkeyt™ was also more beneficial in case of bleeding hemorrhoids as compared to nonbleeding hemorrhoids (P < 0.05). The incidence of adverse drug reactions in both groups was comparable and no patient required any treatment for the same.
  
  
  CONCLUSIONS
  "Arshkeyt™, a 7 day kit," was effective in the treatment of hemorrhoids and had a good safety profile.
authors.affiliation: Department of Clinical Pharmacology and Therapeutics, Seth G.S. Medical College and KEM Hospital, Mumbai, Maharashtra, India.
authors.forename: Raakhi K
authors.initials: RK
authors.lastname: Tripathi
authors.affiliation: Department of Clinical Pharmacology and Therapeutics, Seth G.S. Medical College and KEM Hospital, Mumbai, Maharashtra, India.
authors.forename: Somesh S
authors.initials: SS
authors.lastname: Bolegave
authors.affiliation: Department of Clinical Pharmacology and Therapeutics, Seth G.S. Medical College and KEM Hospital, Mumbai, Maharashtra, India.
authors.forename: Parvan A
authors.initials: PA
authors.lastname: Shetty
authors.affiliation: Department of Clinical Pharmacology and Therapeutics, Seth G.S. Medical College and KEM Hospital, Mumbai, Maharashtra, India.
authors.forename: Dinesh A
authors.initials: DA
authors.lastname: Uchil
authors.affiliation: Department of Clinical Pharmacology and Therapeutics, Seth G.S. Medical College and KEM Hospital, Mumbai, Maharashtra, India.
authors.forename: Nirmala N
authors.initials: NN
authors.lastname: Rege
authors.affiliation: Senior Manager, Medical Services, Solumiks Herbaceuticals Limited, Mumbai, Maharashtra, India.
authors.forename: Mukesh B
authors.initials: MB
authors.lastname: Chawda
authors.affiliation: Department of General Surgery, Seth G.S. Medical College and KEM Hospital, Mumbai, Maharashtra, India.
authors.forename: Sameer A
authors.initials: SA
authors.lastname: Rege
keywords: 2% lidocaine gel; Anal sphincter spasm; isabgul; rectal bleeding; tenesmus
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