"A Randomised Comparative Clinical Study to Evaluate the Efficacy of Yavadi Kalka and Tiladi Kalka after Jaloukavacharana in the Management of Dusta Vrana with special reference to Non Healing Traumatic Ulcer".
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Sign and symptom of dusta vrana non healing ulcer viz. vrana vedana pain Daha burning sensation Kandu Itching Vrana gandha foul smell Vrana varna discolouration Vrana srava discharge Vrana akruti Size shape tenderness
Study Overview
Brief Summary
this study is a open label,two arm randomizatipn active controlled clinical trail assessing the efficacy of yavadi klaka ,local application on dustavrana(non healing traumatic ulcer)once in a day(after single setting of jaloukavacharana)in 20 patients for period of 28days in our centre(BLDEAS AVS ayurveda mahavidyalaya hopsitala and research centre, Vijayapura, Karntaka,India. The primary outcome measures will be signs and symptoms of non healing ulcer compared with control group(Tiladi Kalka) which are treated with Yavadi Kalkain 20 patients in the period of 28dyas.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 16.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient suffering from non healing traumatic ulcer Dusta vrana with size of 10 sq.cm and having signs & symptoms of non haling ulcer(Dustaraktasrava-vitiated blood discharge)Pooti puya(pus discharge)Atee vedana(severe pain),ateeushna(locally raised tempreture)utsadan(elevated edges),raaga9redness),paaka(supporated), deerga kalen(chronic) patients who are fit for jaloukavacharana patients who are ready to participate & sign for inform consent form.
Exclusion Criteria
- •Patient suffering from any bleeding disorders,chronic systemic disorders & infectious diseases like HIV,Hepatitis-B,HCV .
- •Patients of diabetic ulcer,venous ulcer,arterial ulcer,malignant ulcer,tuberculosis ulcer are excluded.
Outcomes
Primary Outcomes
Sign and symptom of dusta vrana non healing ulcer viz. vrana vedana pain Daha burning sensation Kandu Itching Vrana gandha foul smell Vrana varna discolouration Vrana srava discharge Vrana akruti Size shape tenderness
Time Frame: Sign and symptom of dusta vrana non healing ulcer viz vrana vedana pain Daha burning sensation Kandu Itching Vrana gandha foul smell Vrana varna discolouration Vrana srava discharge Vrana akruti Size shape tenderness | above said outcome measures will be assessed on weekly interval
Secondary Outcomes
- effectiveness for anaerobic and aerobic bacteria(Above said outcome measures will be assessed and recoreded on 4weeks)