A Randomized Open Label Controlled Clinical Study To Evaluate The Efficacy of Apamarga Hydrogel in the Management of Dushta Vrana With Special Reference To Grade 1 and 2 Diabetic Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Signs of Wound Healing based on favourable changes in Bates and Jenson Wound Assessment Tool and Vas Scale
研究概览
简要总结
This study has been taken up to evaluate the Efficacy of Apamarga Hydrogel in the management of Dushta Vrana with Special reference to Grade 1 and 2 Diabetic ulcers (as per University of Texas classification of Ulcers) Comparision chosen is Hydroheal AM Hypothesis Null - There is no difference in the efficacy of Apamarga Hydrogel and Hydroheal AM in the management of Dushta Vrana with special reference to Grade 1 and 2 Diabetic Ulcers (as per University of Texas classification of Ulcers)
H1 - Efficacy of Hydroheal AM is better than Apamarga Hydrogel in the management of Dushta Vrana with special reference to Grade 1 and 2 Diabetic Ulcers.
H2 - Efficacy of Apamarga Hydrogel is better than Hydroheal AM in the management of Dushta Vrana with special reference to Grade 1 and 2 Diabetic Ulcers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 70.00 Year(s)（—）
入选标准
- •1.Subjects with Diabetic Ulcers Of Grade 1 And 2 (As Per University Of Texas Classification Of Diabetic Ulcers) 2.Subjects aged between 25-70 Years irrespective Of Gender,Religion,Occupation,Economic Status And Educational Status.
排除标准
- •1.Subjects with Ulcer Grade 3 (As Per Texas Classification Of Diabetic Ulcers) 2.Subjects suffering from Infectious Diseases Like HIV,Hepatitis, Tuberculosis or other Sexually Transmitted Infections 3.Subjects suffering from Osteomyelitis 4.Subjects suffering from Immunocompromised Diseases.
结局指标
主要结局
Signs of Wound Healing based on favourable changes in Bates and Jenson Wound Assessment Tool and Vas Scale
时间窗: 0TH,7TH 14TH 21ST Day
次要结局
- Improved Quality of Life(7TH 14TH 21ST Day)
研究者
Dr Sai Dakshini
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH