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临床试验/CTRI/2020/12/029577
CTRI/2020/12/029577尚未招募不适用

To Evaluate The Efficacy Of Panchavalkala Kashaya In The Management Of Mild To Moderate Infected Wound

Department Of Shalya Tantra1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年12月14日最近更新:

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)

研究者

发起方
Department Of Shalya Tantra
申办方类型
Research institution and hospital

研究点 (1)

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