An Open Label Double Arm Controlled Clinical Trial To Evaluate The Efficacy Of Bhunimba Avachoornana In Dushta Vrana,Chronic Non Healing Ulcer
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
Title:
An open-label, double-arm controlled clinical trial is planned to evaluate the efficacy of Bhunimba Avachurnana in the management of Dushta Vrana (chronic non-healing ulcer). A total of 15 patients will be included in the study and allocated into two groups.
Study Design and Intervention
Group A (Trial Group): External application of Bhunimba Churna as Bhunimba Avachoornana
Group B (Control Group): External application of Neosporin Dusting Powder
Procedure: Dusting of the respective drug uniformly over the wound area
Contact Period: 24 hours
Duration of Treatment: 7 days
Assessment: Dressing will be done daily for 7 days and final assessment will be carried out on the 8th day
Bhunimba Avachoornana Procedure
Purva Karma: Bhunimba Churna is prepared under aseptic conditions following classical Choorna Kalpana methods. The wound is kept open and the patient positioned comfortably.
Pradhana Karma: The wound is cleaned with normal saline, mopped dry, and Bhunimba Avachoornana is uniformly dusted over the entire wound surface.
Paschat Karma: A sterile gauze and pad are applied, followed by secure bandaging. The drug remains in contact with the wound for 24 hours.
Outcome Measures
Primary Objective Parameter: Assessment based on the Bates-Jensen Wound Assessment Tool
Secondary Parameters:
- Vedana (pain)
- Durgandha (foul smell)
- Puya Srava (discharge)
Conclusion
This study aims to scientifically assess the wound-healing efficacy of Bhunimba Avachoornana in Dushta Vrana and compare its effectiveness with a standard control drug using validated wound assessment parameters and appropriate statistical method
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient diagnosed with Dushtavrana having the features of Vrana presenting with Durgandha, Puya Shrava, Vedana and Daha.
- •2.Age between 20 to 60 years irrespective of gender, religion, place and socio-economic status.
- •3.Ulcer size within 5-cm length x breadth and 1-2cm depth 4.Chronicity up to one year.
排除标准
- •Patient aged about 60 years.
- •Patient with Tuberculosis,Malignancy,Severe bleeding disorders,Multiple Ulcers ,Gangrene wound in specific areas like joints,bones and Diabetic mellitus HbA1C greater than 8.
研究者
Dr Prathibha H C
SDM Institute of Ayurveda and Hospital