Randomized, open-label, controlled, comparative clinical study to evaluate the safety and efficacy of Pilex Forte tablets in combination with Pilex Ointment application for the effective management of common ano-rectal conditions

• Authors: Suresh Kumar , Sandhiya Selvarajan , Prasanna Lakshmi , Rangesh Paramesh , Rajesh Kumawat , Palaniyamma D , Srikrishna HA

Abstracts

EN

Introduction. Haemorrhoids and anal fissures are considered as the most common anorectal conditions. Aim. To evaluate the safety and efficacy of Pilex Forte tablets in combination with Pilex Ointment as compared to the Standard of Care in common anorectal conditions. Material and methods. Randomized, open-label, controlled comparative clinical study conducted on 162 patients of either sex, aged between 18-50 years, confirmed with common anorectal conditions. As per randomization, patients received either standard of care or Pilex Forte tablet along with Pilex Ointment at a recommended dose of two tablets twice daily and twice daily local application (anal) for a period of 4 weeks. Clinical safety and efficacy assessments were carried out at study specific scheduled visits. Laboratory assessments were carried out only at screening and at the end of the study. Results. Patients who completed the study were considered for statistical analysis. Significant clinical improvement was observed in patients with anorectal conditions who received Pilex Forte tablet and Pilex Ointment than to those who received standards of care. No abnormal lab values were recorded and there were no adverse events reported during the study period. Conclusion. Pilex Forte tablet along with Pilex Ointment at recommended dose is safe and effective in the management of anorectal conditions like haemorrhoids and fissure-in-ano.

Keywords

EN

anorectal; fissure-in-ano; haemorrhoids

• Publisher: Uniwersytet Rzeszowski. Wydawnictwo Uniwersytetu Rzeszowskiego
• Journal: European Journal of Clinical and Experimental Medicine
• Year: 2021
• Issue: 3
• Pages: 221-232

Dates

published

2021

Contributors

author

Suresh Kumar

• Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India

author

Sandhiya Selvarajan

• Department of Clinical Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India

author

Prasanna Lakshmi

• Directorate of Indian system of Medicine, Puducherry, India

author

Rangesh Paramesh

• Himalaya Wellness Company, Makali, Bengaluru, India

author

Rajesh Kumawat

• Himalaya Wellness Company, Makali, Bengaluru, India

author

Palaniyamma D

• Himalaya Wellness Company, Makali, Bengaluru, India

author

Srikrishna HA

• Himalaya Wellness Company, Makali, Bengaluru, India

Identifiers

DOI

10.15584/ejcem.2021.3.3

Biblioteka Nauki

2040170