An Open label Randomized Controlled Clinical Study to Evaluate the Efficacy of Arka Ksharaplota And Apamarga Ksharaplota in The Management of Dushta Vrana (Putrified Wound)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Significant improvement in Healing rate of Dushta Vrana (Putrified Wound)
研究概览
简要总结
In this Randomized Comparative Clinical study, 64 patients with Dustha Vrana (Putrified Wound) will be enrolled after meeting the necessary criteria and informed consent. In Group A, 32 patients would be treated with Arka Kshara Plota, prepared by Layering Arka Kshara, Snuhi Kshir and Haridra Churna, applied on Alternate Days according to affected area, And in Group B would also have 32 patients, who would receive Apamarga Kshara Plota prepared by the same method as Arka Kshara Plota, with the same dose of medication and intervals. Before starting the treatment, all patients would be tested for essential investigation to ensure they meet the study’s requirements and informed consent will be taken. The effectiveness of the treatment will be assessed based on wound size reduction and significant improvement in the healing rate, After the treatments, the results will be analyzed statistically
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
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with Dushta Vrana (putrified wound) will be selected regardless of sex, religion, or profession. Eligible wounds will have a size of up to 6 cm in diameter or length. The wound types include traumatic, diabetic (control), venous ulcers, or post-surgical wounds (non-infected, granulating). Participants should not have any active systemic infection, with a Total Leukocyte Count (TLC) range between 11,
- •13,000 µL. Additionally, participants must have normal Bleeding Time (BT) and Clotting Time (CT) values. Only those willing to participate and able to provide written informed consent will be included.
排除标准
- •include individuals under 30 or over 70, those with chronic conditions (e.g., tuberculosis, chronic osteomyelitis, malignant ulcers), abnormal BT/CT, HIV, uncontrolled diabetes, snake/insect bite wounds, systemic medications that may affect study outcomes, and pregnant or breastfeeding women.
结局指标
主要结局
Significant improvement in Healing rate of Dushta Vrana (Putrified Wound)
时间窗: 1st- 0 Days | 2nd- 14 Days
次要结局
- Reduction in scoring pattern of sign and symptoms of Dushta Vrana (Putrified Wound) and Improvement in quality of life of patients(1st- 0 Day)
研究者
Dr Aftab Ali
Institute For Ayurved Studies and Research Shri Krishna AYUSH University