Clinical trial on Effect of Vikeshika prepared with Malahara using Madhu-Sarpi in management of Dushta Vrana ( infected Wound).

Phase 2/3

Not yet recruiting

Conditions: Non-pressure chronic ulcer of unspecified part of lower leg. Ayurveda Condition: DUSHTAVRANAH,

Registration Number: CTRI/2023/08/056447

Lead Sponsor: Dr Dhriti Khandelwal

Brief Summary: Discontinuation of skin and its underlying tissues is *Vrana*, scar of which remains lifelong until death. Longstanding *Vrana* is known as *Dushta Vrana*. *Dushta Vrana* is a common and often encountered problem faced in surgical practice. The presence of *DushtaVrana* worsens the condition of the patient with different complications and may become fatal. Local factors on wound like slough, infection and foreign body, affect the normal process of healing. Therefore, in the present concept all efforts are directed to keep the wound clean during the various stages of its healing. Good wound healing with minimal scar formation with least pain effectively is the prime motto of every surgeon. The management of *Vrana* and *Dushta Vrana* with the help of 60 *Upakrama* have been enumerated. Among these, application of *Vikeshika* has been mentioned for both *Vrana Shodhana* and *Vrana Ropana karma*. Lot of references are available on use of *Purana madhu* & *Gritha* used as *Vrana Shodaka* and *Vrana Ropaka*. *Sushruta* mentions 13 types of *Vrana Bandhana* for healing purpose in different forms like *Vikeshika, Kavalika, Plota, Pichu,*etc. But these techniques are not widely used in clinical practice, hence there is lot of scope for research. The conventional method of applying *Lepa / Kalka / Taila* / any other topical applications, though effective yet is quite lengthy and process requiring lot of time and is tedious, also there is lot of drug wastage seen usually with insufficient contact time provided. Hence, keeping these into consideration, this study is undertaken due to its accessibility and easier application with an intention to explore the effect of *Vikesika* prepared with *Malahara* using *Madhu-Sarpi* in management of *Dushta Vrana* which will be an innovative contribution in Ayurvedic dressing method.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

1.Subjects of age group between 18-60 years irrespective of Gender 2.Ulcer which has not been healed within 28 days 3.Ulcer within the size of 7X7 cms.

Exclusion Criteria

Patients who are a Known Case of- 1.Tuberculosis, Uncontrolled Diabetes mellitus with HbA1C > 8 % 2.Malignant ulcers 3.Human Immunodeficiency Virus, Hepatitis B 4.Buergerâ€™s disease 5.Osteomyelitis.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Healthy granulation tissue	At baseline,7th,14th,21st & 28th day
Reduction in discharge from wound	At baseline,7th,14th,21st & 28th day
Reduction in pain	At baseline,7th,14th,21st & 28th day

Secondary Outcome Measures

Name	Time	Method
Burning sensation	Itching

Trial Locations

Locations (1): Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan
🇮🇳
Hassan, KARNATAKA, India
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan
🇮🇳Hassan, KARNATAKA, India
Dr Dhriti Khandelwal
Principal investigator
9591096541
dhritikhandelwal96@gmail.com