wound(Vrana)

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2020/12/029577
• Lead Sponsor: Department Of Shalya Tantra

Brief Summary

**objective**:-

To Assess the Efficacy of Panchavalakala Kashaya in management of mild to moderate infected wound.

**Plan of Study**-

Total 40 Patients of vrana will be registered from OPD/IPD of Department of Shalya Tantra, S.S.H., B.H.U., Varanasi. Patients will be registered urespective of their age, sex and religion which are fulfilling the inclusion and exclusion criteria.

Patients will be enrolled after thorough interrogation, laboratory investigations and clinical assessment on a set proforma.

Effect of Panchavalkala kwatha is compared with normal saline. Clinical study will be conducted on patients with infected wound by randomly dividing them into 2 groups :-

A)  0.9% Normal Saline (Control Group)

B)   Panchavalkala Kwatha (Trial Group)

**Lab.****Investigations**:

Hb%

Total and differential WBC count with ESR

Serum creatinine/ Blood urea

Blood sugar

RFT/LFT

Wound microbial load count (Asses for bactarial load range between mild to moderate)

Wound tisue biopsy-HPE ( 0 day and 28th  day)

HIV

·      Hbs Ag

**Assessment criteria-:**

**Subjective -:**

Physical Examination of the wound:

**Objective -:**

**Microbiological  study-** (Assess for bacterial load range between mild to                    moderate)

**Histopathological examination**

(Registration day - 0 day After    - 28th day)

**Biochemical Parameter-:**

To Assess Quantitative Estimation of VEGF, before treatment (0 day), during treatment (14 and 28 day).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-14
• Last Update Posted: 2023-08-09

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Controlled diabetes mellitus 2.
• Mild to moderate infected wound.

Exclusion Criteria

• Malignant Ulcer 2.
• Ulcers in Uncontrolled Diabetics 3.
• HIV or any immunodeficiency condition 4.
• Hbs Ag Positive 5.
• Tubercular Ulcer 6.
• Leprotic Ulcer 7.
• Any Malignancy 8.
• Renal Failure 9.
• Cardiac Failure 10.
• Venous Ulcer 11.
• Arterial Ulcer 12.
• Who are not willing to give written informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SIZE	0-28 DAYS
DEPTH	0-28 DAYS
EDGES	0-28 DAYS
UNDERMINING	0-28 DAYS
NECROTIC TISSUE TYPE	0-28 DAYS
NECROTIC TISSUE AMOUNT	0-28 DAYS
EXUDATE TYPE	0-28 DAYS
EXUDATE AMOUNT	0-28 DAYS
SKIN COLOR SURROUNDING WOUND	0-28 DAYS
PERIPHERAL TISSUE EDEMA	0-28 DAYS
PERIPHERAL TISSUE INDURATION	0-28 DAYS
GRANULATION TISSUE	0-28 DAYS
EPITHELIALIZATION	0-28 DAYS

Secondary Outcome Measures

Name	Time	Method
SIZE	DEPTH

Trial Locations

Locations (1)

Institute Of Medical Sciences,B.H.U,; 🇮🇳 Varanasi, UTTAR PRADESH, India

Institute Of Medical Sciences,B.H.U,

🇮🇳Varanasi, UTTAR PRADESH, India

DrAwadhesh Kumar Pandey

Principal investigator

07376887965

awadheshoct20@gmail.com