An Open-label single arm pilot clinical study to evaluate the effect of PK-SHRI herbal cream in managing Acute traumatic wounds.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Swelling, margin and scar.
研究概览
简要总结
Any physical injuriesresulting in a breakage of the skin are known as wounds which can becategorized into two types namely: acute and chronic wounds. Ideal healing ofthe wounds is necessary to restore the normal functioning of the skin. Thereare several medications available to manage the wounds. The World HealthOrganization is also encouraging the use of traditional medicines in developingcountries as these are cheaper than synthetic drugs and also have minimal sideeffects on the patient. In this study, we willformulate herbal cream from the extracts of Aristolochia indica, Andrographispanicualta, Commiphora caudata, Chloroxylon swietenia &Tridaxprocumbensbased on the results obtained from in-vivo studies. The plants selected for formulating the herbalformulations have significant antibacterial, immunomodulatory andanti-inflammatory activities, which are complementary to the wound healingprocess. The growing popularity of natural and herbal medications, the easyavailability of raw materials, cost-effectiveness and the paucity of reportedadverse reaction, prompted us to formulate a polyherbal topical preparation andassess its wound healing ability. The combination is used in order to enhancethe wound healing activity
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •1.1.Adults of age group between 18-70 years of either gender with Acute traumatic wound presenting with classical signs and symptoms.
- •Patients willing to sign informed consent.
排除标准
- •1.Patients suffering from chronic acute traumatic wounds, varicose ulcers, Diabetic ulcers, lepromatous ulcers, syphilitic ulcers, skin malignancies, and known HIV.
- •2.Acute traumatic wounds occurring on head, face, breast, perinium.
- •3.Pregnant and lactating mothers.
结局指标
主要结局
Swelling, margin and scar.
时间窗: Burning, Colour, Tenderness | Swelling Will be assessed on 0th 7th & 14th day. | Scar will be assessed on 28th & 45th day. | Margin will be assessed on 0th 7th 14th 28th and 45th day.
The effect of PK-SHRI herbal cream in managing Acute traumatic wounds by accessing Burning, Colour, Tenderness
时间窗: Burning, Colour, Tenderness | Swelling Will be assessed on 0th 7th & 14th day. | Scar will be assessed on 28th & 45th day. | Margin will be assessed on 0th 7th 14th 28th and 45th day.
次要结局
- to check the effect of PK-SHRI herbal cream in managing in pain & inflammation(Will be assessed on 0th & 7th day)
