跳至主要内容
临床试验/CTRI/2024/06/069115
CTRI/2024/06/069115尚未招募3 期

An exploratory study to evaluate the wound healing activity of Priyangudhatakyadi Taila in Dushta Vrana with special reference to chronic wounds

Department of Shalyatantra1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月25日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
1. Assessment of the wound healing activity of Priyangudhatakyadi Taila

研究概览

简要总结

This randomized controlled clinical trial on chronic wound is with objectives of to assess the wound healing activity of Priyangudhatakyadi Taila, to assess the wound healing rate in 28 days and to compare wound healing activity of trial drug and control drug.

Total 40 patients of chronic wounds will be registered irrespective of their gender and religion which are fulfilling the inclusion and exclusion criteria. Patients will be enrolled after thorough history taking, clinical examination, laboratory investigations on a specially prepared proforma. Registered patients will be randomly divided into two groups each contains 20 participants each. In trial group- After cleaning of wound with normal saline, gauze soaked with Priyangudhatakyadi Taila will be applied and in control group gauze soaked with Povidone iodine will be used followed by bandage once daily for 28 days or till the complete healing of wounds (whichever is earlier).

It will be assessed by different parameters like wound characteristics (pain, wound bed, odor and granulation tissue), wound measurements (by linear measurement, serial photography and unit healing time), histopathological study and microbial load.

At the end of the study, appropriate statistical test will be applied as per types of data.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Mild and moderately infected wounds of all types
  • Patients with controlled diabetes.

排除标准

  • Malignant ulcers
  • Tuberculous ulcers
  • Syphilitic ulcers
  • Leprotic ulcer and other specific ulcers
  • Actinomycosis
  • Wounds with associated Osteomyelitis
  • Malnutrition
  • Wounds in HIV patients and immuno-compromised patients.

结局指标

主要结局

1. Assessment of the wound healing activity of Priyangudhatakyadi Taila

时间窗: 28 days

2. Assessment of wound healing rate

时间窗: 28 days

次要结局

  • 1. Comparison of wound healing activity of trial drug and control drug(28 days)

研究者

发起方
Department of Shalyatantra
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Nasrin Habeeb

Banaras Hindu University

研究点 (1)

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