To Evaluate The Efficacy Of Panchavalkala Kashaya In The Management Of Mild To Moderate Infected Wound
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- EXUDATE AMOUNT
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 35.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Controlled diabetes mellitus
- •Mild to moderate infected wound.
排除标准
- •Malignant Ulcer
- •Ulcers in Uncontrolled Diabetics
- •HIV or any immunodeficiency condition
- •Hbs Ag Positive
- •Tubercular Ulcer
- •Leprotic Ulcer
- •Any Malignancy
- •Renal Failure
- •Cardiac Failure
- •Venous Ulcer
- •Arterial Ulcer
- •Who are not willing to give written informed consent.
结局指标
主要结局
EXUDATE AMOUNT
时间窗: 0-28 DAYS
SIZE
时间窗: 0-28 DAYS
DEPTH
时间窗: 0-28 DAYS
EDGES
时间窗: 0-28 DAYS
UNDERMINING
时间窗: 0-28 DAYS
NECROTIC TISSUE TYPE
时间窗: 0-28 DAYS
NECROTIC TISSUE AMOUNT
时间窗: 0-28 DAYS
EXUDATE TYPE
时间窗: 0-28 DAYS
PERIPHERAL TISSUE EDEMA
时间窗: 0-28 DAYS
SKIN COLOR SURROUNDING WOUND
时间窗: 0-28 DAYS
PERIPHERAL TISSUE INDURATION
时间窗: 0-28 DAYS
GRANULATION TISSUE
时间窗: 0-28 DAYS
EPITHELIALIZATION
时间窗: 0-28 DAYS
次要结局
- SIZE(DEPTH)
