title: Efficacy of a standardized herbal preparation (Roidosanal(®)) in the treatment of hemorrhoids: A randomized, controlled, open-label multicentre study.
abstract: BACKGROUND
  Catechins and epicatechins are monomers of naturally occurring proanthocyanidins, which have been reported with free radical scavenging, antioxidant, antiinflammatory, antiallergic, and vasodilatory properties. Plant parts rich in proanthocyanidins have been used for years in treatment of various ano-rectal diseases. This study compares the efficacy of two herbal preparations, Daflon(®) 500 mg and Roidosanal(®), in ameliorating the signs and symptoms associated with hemorrhoids.
  
  
  OBJECTIVE
  To evaluate the safety and to compare the efficacy of a herbal preparation, Roidosanal(®) versus Daflon(®) 500 mg, on signs and symptoms of hemorrhoidal disease.
  
  
  METHODS
  In this pilot, active controlled, open-labeled multicentre study, 73 patients with proctoscopy proven hemorrhoids (Grade I to III) were randomly assigned to receive either Roidosanal(®) (Gr R; n = 37) or Daflon(®) 500 mg (Gr D; n = 36), for 15 days, at three centers in India. Assessment of hemorrhoidal symptoms was carried out in all patients at different time points. Intent-to-treat analysis was performed for both primary and secondary endpoints.
  
  
  RESULTS
  Baseline characteristics were comparable between the two groups. Both products were found to be equally effective in improving the ano-rectal conditions in Grade I and Grade II hemorrhoids; however, Roidosanal(®) demonstrated better efficacy in patients with Grade III hemorrhoids. Hemorrhoids associated symptoms like bleeding, pain, etc., improved in both groups, although intergroup comparisons were comparable.
  
  
  CONCLUSIONS
  Both Roidosanal(®) and Daflon(®) 500 mg were equally effective in resolving signs and symptoms of hemorrhoids. Roidosanal(®) can be tried as a safe and effective treatment option for treatment of hemorrhoids. Further randomized, double-blind and large multicentre studies are recommended.
authors.affiliation: General and Laparoscopy Surgery, Mohinder Hospital, Green Park, New Delhi, India.
authors.forename: Kapil
authors.initials: K
authors.lastname: Aggrawal
authors.affiliation: General and Laparoscopy Surgery, Batra Hospital, New Delhi, India.
authors.forename: Naveen
authors.initials: N
authors.lastname: Satija
authors.affiliation: South End Clinic, Jain Mandir Complex, Masjid Modh, New Delhi, India.
authors.forename: Gita
authors.initials: G
authors.lastname: Dasgupta
authors.affiliation: Former Drugs Controller General (I), Purvasa Apartments, Mayur Vihar, New Delhi, India.
authors.forename: Partha
authors.initials: P
authors.lastname: Dasgupta
authors.affiliation: Department of Pharmacology, Delhi Institute of Pharmaceutical Sciences and Research, Sec 3 Pushp Vihar, New Delhi, India.
authors.forename: Parul
authors.initials: P
authors.lastname: Nain
authors.affiliation: Consultant, Choice Apartments, Mehrauli, New Delhi, India.
authors.forename: Aditya R
authors.initials: AR
authors.lastname: Sahu
keywords: Bleeding; catechins; flavonoids; hemorrhoids; proctoscopy