AN OPEN RANDOMISED CLINICAL CONTROL TRIAL OF EFFECT OF APAMARGA KSHAR TAILA WITH ADJUVANT DRUG THERAPY IN MANAGEMENT OF SHARAVIKA PRAMEHA PIDIKA WITH SPECIAL REFERENCE TO DIABETIC ULCER
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- To Evaluate the efficacy of Apamarga Kshar Taila with adjuvant drug therapy in management of Shravika Prameha Pidika
研究概览
简要总结
Diabetes is a disease known for its multifaceted complications. Diabetic ulcer is one of the major complications of diabetes. Thousands of researches are being carried out on this in which Ayurveda has a major role. Brihatatryis have described Prameha Pidaka as a major complication of Prameha. These Pidakas are mainly found in muscular region, joints and vital points (Marmas). Different numbers of Prameha Pidakas are mentioned in Ayurvedic Classics. According to Sushruta there are 10 different types of Prameha Pidakas.Prameha pidika is seen as debilitating and Scoring disorder seen in the human being suffering from diabetes.it is very important and widely described chapter of shalya tantra.Su.Ni. 6/14
Pidaka which is raised at the margin and dipped in its centre, so as to resemble as Saucer in its shape is called as Sharavika.
Diabetese affects more than 9.3% of Indian adult population. Up to 25% of diabetic patients develop foot ulcers. More than half of foot ulcers become infected and require hospitalisation and 20% of infections results in amputation. Early effective management can reduce the severity of complications such as preventable amputations and possible mortality and can also improve overall quality of life.
This study is randomized open controlled trial to evaluate the efficacy of Apamarga Kshar taila in the management of Sharavika Prameha PIdika as trial drug and EUSOL as control drug. Trial and control drugs applied on the diagnosed cases of Sharavika prameha pidika for 15 days and as per need. After 15 days patient is advice to come on 5th, 10th, 15 th day for follow up. 44 patients in each group will be studied. Study will be conducted in India. Outcome of study will be asses onbetter healing and reduction of signs and symptoms of wound.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient suffering from Non Insulin Dependent Diabetes mellitus and Insulin Dependent Diabetes mellitus.
排除标准
- •Patient suffering from Malignant ulcer Tubercular ulcer Venous ulcer HIV and HBsAg.
结局指标
主要结局
To Evaluate the efficacy of Apamarga Kshar Taila with adjuvant drug therapy in management of Shravika Prameha Pidika
时间窗: at 1st day, 5thday and 15th day
次要结局
- To compare the efficacy of EUSOL & Apamarga Kshar taila with Adjuvant Drug Therapy in manangement of Sharavika Prameha Pidika(at 1st day , 5th day & 15th day)
研究者
Shaikh Arham Sarosh Mohd Asif
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta
