International Journal of Drug Delivery Technology
Volume 16, Issue 4s, 2026

A Randomised Control Study Using Oral Micronized Purified Flavonoid Fraction Versus Topical Glycerine Magnesium Sulphate Application in the Surgical Management of Grade 3 and 4 External Hemorrhoids

Dr S Akash1, Dr Madan Mohan Reddy2, Dr G Shivashekar3, Dr Debaraath Das4, Dr Pravin Dhas5, Dr Karthika SP6, Dr Lakshmana Raman7

1Postgraduate Student, Department of General Surgery, SRM Medical College Hospital and Research Centre, SRM Institute of Science and Technology University, Kattankulathur, 603203

2,3,4,5,6,7Department of General Surgery, SRM Medical College Hospital and Research Centre, SRM Institute of Science and Technology University, Kattankulathur, 603203

5Mail Id: Pravinda@Srmist.Edu.In


ABSTRACT

Background: Hemorrhoidal disease is a common anorectal condition that significantly affects patient quality of life. Advanced hemorrhoids, particularly Grade III and IV external hemorrhoids, often require surgical management due to persistent prolapse, bleeding, and pain. Postoperative complications such as edema, inflammation, and delayed wound healing remain significant concerns. Pharmacological adjuncts aimed at reducing inflammation and improving microcirculation may enhance postoperative outcomes. Oral micronized purified flavonoid fraction (MPFF) has demonstrated venotonic, anti-inflammatory, and capillary-protective effects, whereas topical glycerine magnesium sulphate (GMS) primarily acts locally through osmotic mechanisms to reduce edema.

Aim: To evaluate and compare the effectiveness of oral micronized purified flavonoid fraction and topical glycerine magnesium sulphate in the surgical management of Grade III and IV external hemorrhoids.

Objectives: • To assess the effectiveness of oral MPFF and topical GMS in hemorrhoid management. • To analyze intraoperative bleeding in patients receiving MPFF versus GMS. • To evaluate postoperative bleeding episodes in both treatment groups. • To compare postoperative pain using the Visual Analog Scale (VAS). • To examine differences in outcomes based on age and gender. • To determine the relative effectiveness of both therapeutic approaches.

Methodology: This study was conducted as a randomized controlled trial in the Department of General Surgery at SRM Medical College Hospital and Research Centre, Tamil Nadu. A total of 100 patients diagnosed with Grade III or IV external hemorrhoids were included and randomly allocated into two groups of 50 participants each. Group A received oral micronized purified flavonoid fraction (Daflon 500 mg, two tablets twice daily) for four weeks preoperatively, followed by hemorrhoidectomy. Group B received topical glycerine magnesium sulphate application for the same duration before undergoing hemorrhoidectomy. Primary outcomes measured included reduction in hemorrhoid size, intraoperative bleeding, postoperative bleeding, and postoperative pain scores measured using the Visual Analog Scale. Secondary outcomes included postoperative complications, recovery time, and demographic influences such as age and gender. Statistical analysis was performed using SPSS version 26. Continuous variables were analyzed using independent t-tests or Mann-Whitney U tests, while categorical variables were analyzed using chi-square tests. A p-value <0.05 was considered statistically significant.

Results: It is expected that oral MPFF will demonstrate superior systemic effects through improved venous tone, reduced capillary permeability, and anti-inflammatory action, potentially resulting in reduced intraoperative bleeding and improved wound healing. Topical GMS is expected to provide rapid localized relief by reducing postoperative edema and associated pain.

Conclusion: Both MPFF and topical GMS play beneficial roles in the perioperative management of advanced hemorrhoids through different mechanisms. MPFF provides systemic vascular and anti-inflammatory benefits, while GMS offers local edema control and symptomatic relief. Comparative evaluation of these interventions may help optimize postoperative recovery strategies in hemorrhoidectomy patients and guide future clinical practice.

Keywords: Hemorrhoids; Hemorrhoidectomy; Micronized purified flavonoid fraction; Glycerine magnesium sulphate; Randomized controlled trial; Postoperative pain

How to cite this article: Akash S, Reddy MM, Shivashekar G, Das D, Dhas P, Karthika SP, Raman L. A Randomised Control Study Using Oral Micronized Purified Flavonoid Fraction Versus Topical Glycerine Magnesium Sulphate Application in the Surgical Management of Grade 3 and 4 External Hemorrhoids. Int J Drug Deliv Technol. 2026;16(4s): 105-110. DOI: 10.25258/ijddt.16.4s.13

Source of support: Nil.

Conflict of interest: None