An Open Label Randomized Controlled Clinical Study To Evaluate The Efficacy Of Manjistadi Ghrita Vikeshika And Jathyadi Ghrita Vikeshika In The Management of Dusta Vrana vis-a-vis Venous Ulcer.

Venous leg ulcers(VLUs) are common wounds that can deeply affect patient quality of life, which is challenging to healthcare systems due to its chronicity, non–healing in  nature.The high rate of recurrence (50-70%) can lead to longer term psychosocial effects, such as depression,anxiety,self-esteem issues and a decreased quality of life.VLUs are the most commonest ulcers found among chronic leg ulcers.70 to 90% of chronic leg ulcer is of venous origin. If this ulcer left untreated or not properly treated, they can lead to cellulitis, gangrene and even amputation of the affected limb. India has high prevalence rate of 4.5 cases per 1000 population in a year.The overall incidence is higher for females than males, although the exact number is hard to establish as it depends on the cohort and place of study.The VLU’S are non-healing in nature and most commonly seen in medial and lateral aspect of the ankleregion (gaiter’s zone).

The standard care for VLUs relies on conservative treatment and wound management. Conservative treatment includes compression therapy and supportive measures(physical therapy,manual lymphatic drainage, phlebotonics for symptom relief). Regarding direct ulcer interventions,like cleansing, debridement, infection control, applications of dressings and topical substances are in practice(5). Other approaches include sclerotherpy, surgicalprocedures, endovenous ablation techniques which are invasiveprocedures,expensive,chances of recurrence and can decrease the quality of life.

The wound dressings maintain adequate moisture, offer physical protection, promote granulation and re-epithelization but the  management of chronic venous ulcers is a challenging one(6). There  are numerous types of sterilized, packed dressing materials like semi-permeable film dressings, semi-permeable foam dressings, sofra tulle dressings, fixation sheets, alginate dressings, hydrocolloid and hydrogel dressings available in the market.Dressing selection is another key consideration in the VLU management. Appropriate dressings can perform in conjunction with compression therapy while also minimizing dressing related pain and trauma and avoiding unnecessary dressing changes ,in which all contributes to a better quality of care,an improved quality of life and restore patient confidence.

Hence for the standardization, advancement and betterment  in the field of dressing methodology without altering the basic principles, here an attempt is being made to prepare Manjistadi Ghrita Vikeshikausing leno weave non absorbent gauze impregnated with Manjistadighritawith standard size, sterilized and sealed in a pack which might be an innovative contribution in the field of vranamanagement in Ayurveda.

Sample size :

40 subjects selected for the study will be randomly (by lottery method) allocated and divided into 2 groups

GROUP - A:  20 subjects will be applied with ManjistadighritaVikeshika.

GROUP - B:  20 subjects will be applied with JathyadiGhritavikeshika.

Observational Period:  Dressing will be done everyday and weekly observations will be noted i.e on-before treatment,7th, 14th, 21st and on 28th day.

Study duration **:**28 days.

Follow up Period: 35th day and 42nd day.

Preparation Of Vikeshika:

The drugs mentioned will be taken in equal quantity with double the quantity of  Moorchitha Ghritathen four  parts of water will be added to it and shall be  cooked on mild heat until it attains *Ghritapaka siddhi lakshana .*The Ghritawill be filtered and after cooling it will be stored in air tight container.

UV  Sterilized clean leno-weave  fabric gauze of 10 ×10 cm size will be taken.

It will be impregnated with Manjistadi ghrita/Jathyadi ghritauniformly.

Thus prepared vikeshika will be kept in between layers of  sterilized silver foil and sterilized butter paper in order to prevent leakage of ghritha. Then it will be  kept inside sterilized silver foil pouch ,sealed and stored in cool temperature.