An open realistic prospective interventional clinical trial to evaluate the efficacy of medicinal leech therapy (Jalaukavacarana) in the treatment of Varicose Ulcer.

Bloodletting by means of Jalouka (leech) is called Jaloukavacharana in Ayurveda literature. Jalouka is considered the best among the Sastras (surgical instruments) and Anusastras (para surgical instruments). Jaloukavacharana is applied by Ayurvedic practitioners in the management of various dermatological conditions, chronic non-healing ulcers, deep vein thrombosis. Varicose ulcers (venous insufficiency ulcers) are wounds that occur due to improper functioning of venous valves 70% to 90% of leg ulcers are venous in origin. Venous ulcers develop mostly along the medial distal part of leg and can be painful; the ulcer may get infected leading to cellulitis or gangrene. Ayurveda also mention about chronic ulcers. In Susrutha Samhita, Sutrasthana Chapter13 information regarding the  Jalukavacharana are there.

The current study will be a prospective interventional clinical trial to evaluate the efficacy of medicinal leech therapy (Jalaukavacharana) in the treatment of varicose ulcer.Leech therapy mentioned in ayurvedic classics for Ulcer management is adopted here for better understanding and standardization of the procedure. Jalaukavacarana will be done daily after following the procedure as per the classical references in Ayurveda. In this study we are planning to do intervention in 100 subjects who satisfies the inclusion criteria.

The initial assessment will be done before the commencement of the study. The assessment parameters include Demographic data, Medical history (includes systemic examination),Vital signs (Blood pressure, Heart rate , Pulse rate,temperature),Past surgical history, Laboratory investigations include Fasting blood sugar,Post prandial blood sugar,HbA1c,Hb,TC,DC,ESR,Bleeding time, Clotting time, HIV,HbsAg, Doppler venous study, Wound assessment tool( LEG ULCER) for qualitative analysis and Pain assessment ( VAS score). Further assessment will be done on the day 15 (visit 2), day 30 (visit 3), day 45 (visit 4) and day 60 (visit 5). Qualitative and Quantitative analysis of data regarding wound healing will be statistically Analysed.