Comparative Evaluation of the Efficacy of Hydrocortisone Suppository and Durvadi gudavarti in Raktarsha: A Management Protocol

Abstract

The most common diagnosis for any anorectal complaint particularly of rectal bleeding in adults is haemorrhoidal disease. Regardless of grading conservative treatment is used primarily in symptomatic haemorrhoids. In Ayurveda, Sthanik Chikitsa (Local application) in the management of Arsha (Hemorrhoids) includes pralepa/pratisaran (Paste application). Instead of applying the lepa in the clinics by the clinician/proctologist, those formulations could be developed into Gudavarti (traditional suppository) & used in the management of Raktarsha (bleeding piles) for better compliance. Hence, development of ‘Durvadi Gudavarti’ using the indigenous medicinal herbs mentioned in Charaka Sanhita (Classical Ayurveda text) for pratisaran/pralepa in Raktarsha & its efficacy will be evaluated. Objectives: To study & compare the efficacy in patient treated with standard- Hydrocortisone suppository group & interventional- Durvadi Gudavarti group in the management of Raktarsha (Bleeding piles). Methodology: 130 patients of 2nd grade hemorrhoids will be selected and will be allocated into two equal groups by computer randomization. Experimental group will be treated with Durvadi Gudavarti & control group with Hydrocortisone based suppository for 2 weeks. Following Symptoms- PR Bleeding, Anal Pain, Prolapse of Pile mass/Lump, Anal pruritus, Mucous discharge & Constipation will be assessed subjectively and Size/ (Volume in cubic millimeter) of pile mass will be the objective parameter for study. Clinical evaluation will be done at Baseline and 3rd, 5th, 10th, 15th day after treatment onset. Proportion of patients that would respond clinically on 10th day will be the main end point, determined via disappearance of the clinical symptoms & more than or equal to 50 % reduction in the initial size of pile mass/lump. Time to response & need for any oral/ parenteral medication for pain, bleeding and constipation would be the secondary variables. Side effects (type, duration & severity) will be registered carefully. Expected Results: Durvadi Gudavarti contains indigenous herbs having anti-inflammatory, analgesic, haemostatic, wound healing, astringent, & laxative properties. Hence, it is expected to be as efficacious as Hydrocortisone suppository with lesser side effect in the management of Raktarsha. Results will be assessed on the basis of clinical assessment criteria using proper statistical values and tools. Changes will be observed in objective outcomes. Conclusion: Durvadi Gudavarti will be efficacious in the management of Raktarsha.