A Randomized Controlled Clinical Trial To Evaluate The Shodhan Effect Of Gandirikadi Tailam Application In The Management Of Dushta Vrana.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To study the shodhan effect of Gandirikadi tailam application in the management of Dushtavrana .
研究概览
简要总结
Title :- Randomized controlled clinical trial to evaluate the Shodhan effect of Gandirikadi tailam application in the management of Dushtavrana (infected wound).
Null Hypothesis :- Gandirikadi tailam application is not significantly effective in the management of *Dushtavrana (*infected wound).
Alternative hypothesis :- Gandirikadi tailam application is significantly effective in the management of Dushtavrana (infected wound).
Study design :- Simple Randomized Controlled Clinical Trial.
Inclusive criteria :-
-
Age - Patient age between 18 to 70 years old.
-
Patient having complaints of infected chronic wound , Pus discharge through wound ,Itching , Pain ,Foul smell , slough ,Redness, Swelling.
-
Wound size up to 10 cm.
-
Diabetic patients only those who are on treatment and maintaining their BSL.
-
Patients who are ready to give written consent only will be selected.
Exclusive criteria :-
-
Patient having Malignant ulcer, Tubercular ulcer ,Gangrenous ulcer and Osteomylitis will be excluded.
-
Patient who are not ready to give written consent .
-
Uncontrolled Diabetic patient.
-
AIDS and HIV positive patients.
Sample size :- Total 40 (20 for each group)
Patients coming in OPD and IPD of Shalyatantra department of our hospital with complaints of Dushtavrana (infected wound). Simple Randomized Sampling (Lottery Method ).
Group A:- Gandirikadi Tailam
Group B :- Eusol with Betadine
Total duration of Drug administration is 12 days ( daily dressing with gauze soaked in Gandirikadi tailam in Group A and Eusol with betadine in Group B will be done for 12 days or till appearance of healthy wound). the mode of drug administration is local application.
Follow up :- Baseline screening will be done on 0th day and follow up will be done on 4th 8th and 12th day.
Result :- Result will be drawn as per assessment criteria and statistical analysis.
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
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient having complaints of infected chronic wound,Pus discharge through wound ,itching,Pain,Foul smell,Slough,Redness,Swelling 2)wound size up to 10 cm 3)Diabetic patient only those who are on treatment and maintaining their BSL 3)Patient who are ready to give written consent only will be selected.
排除标准
- •Patient having Malignant ulcer,Tubercular ulcer,Gangrenous ulcer and Osteomylitis will be excluded 2)Patient who are not ready to give written consent 3)Uncontrolled diabetic patient 4) AIDS and HIV positive patients.
结局指标
主要结局
To study the shodhan effect of Gandirikadi tailam application in the management of Dushtavrana .
时间窗: 12 days study | with baseline screening on 0th day. | Follow-up on 4th,8th,12th day
(Primary outcome will be assessed on the basis of certain objective and subjective parameters such as pain discharge tenderness floor and granulation tissue, malodour, size of wound results will be drawn with scoring system)
时间窗: 12 days study | with baseline screening on 0th day. | Follow-up on 4th,8th,12th day
次要结局
- 1)To study etiopathogenesis of Dushta vrana .(2)To study the literature of Gandirikadi tailam.)
研究者
Dr Payal Gajanan Gaddamwar
Mes Ayurved Mahavidyalaya