Suresh Kumar
Sandhiya Selvarajan
Prasanna Lakshmi
Rangesh Paramesh
Rajesh Kumawat
Palaniyamma D
Srikrishna HA
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
Suresh Kumar
Sandhiya Selvarajan
Prasanna Lakshmi
Rangesh Paramesh
Rajesh Kumawat
Palaniyamma D
Srikrishna HA
Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India
Department of Clinical Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India
Directorate of Indian system of Medicine, Puducherry, India
Himalaya Wellness Company, Makali, Bengaluru, India
Himalaya Wellness Company, Makali, Bengaluru, India
Himalaya Wellness Company, Makali, Bengaluru, India
Himalaya Wellness Company, Makali, Bengaluru, India
Received: 28 April 2021 / Accepted: 8 July 2021 / Published: 30 September 2021
Abstract
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.
Cite
Kumar S, Selvarajan S, Lakshmi P, Paramesh R, Kumawat R, Palaniyamma D, Srikrishna HA. 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. Eur J Clin Exp Med. 2021;19(3):221–232. doi: 10.15584/ejcem.2021.3.3.
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