AN OPEN LABEL RANDOMISED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF APAMARGA KSHARAPLOTA WITH SHWETA ARKA KSHARAPLOTA IN THE MANAGEMENT OF KAPHAJA DUSHTA VRANA Vis-a-vis DIABETIC FOOT ULCER.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- OBJECTIVE PARAMETERS:
研究概览
简要总结
NEED FOR THE STUDY:
The word “Vrana” derived from the root word “Vran” means the splitting/tearing of the tissue and eventually leaves an imprint1. Dushta vrana which can be co-related to any non healing ulcer and it is more crucial to debride, promote epithelialization and make it possible to reach healthy granulation tissue. If this ulcer left untreated or not properly treated, they can lead to complications.
In present era, about 60% of diabetics will develop neuropathy, eventually leading to foot ulcer. The common causes are poor control of blood sugar level, foot deformities and improper care.
Annual incidence of diabetic foot ulcer World wide is between 9.1-26.1 millions2. Around 15 – 25% of those will develop foot ulcer during their life time3. Overall about 5% of diabetic patients develop foot ulcer and 1% of them end up in amputation.
Diabetic foot ulcers(DFUs) (30.5%), for example, have a comparable 5-year mortality rate to cancer (31%),which has remain unchanged since 2007 and yet funding for studies related to these life-threatening complications remains significantly lower than that for cancer research4 .
Despite recent advances in antibiotics, topical creams, skin grafting, reconstructive surgery, and other medical treatments, it is still impossible to prevent gangrene. Managing diabetic wounds has never been an easy task for surgeons. This issue has seen as an ensuing need for amputation. Finding effective and secure interventions and medications is an ongoing search given the seriousness of the disease and lack of appropriate treatments.
Acharya Sushsruta mentioned Kshara Karma as one among Shasti upakrama of vrana 5. Kshara is an alkaine substance prepared through classical methodology, having Chedana, Bhedana, Lekhana, tridoshagna6 properties also described as Anushastra and Upayantra.
Acharya Sushruta mentioned various types of bandaging techniques and bandaging materials for healing purposes in different forms like Vikeshika, Kavalika, Plota and Pichu7. Among them Plota is selected for the study. Studies have found that Ksharaplota is having Shodhana , Ropana properties.
Ksharaplota offers distruction of unhealthy tissues, draining of the debris and simultaneously enhances granulation process. Combination of Shweta Arka kshara, Snuhi ksheera and Haridra having lekhana, shodhana and ropana properties, promotes neovascularization and faster wound healing by its anti-inflammatory, anti-microbial and antioxidant activities.
Here is an attempt made to evaluate the efficacy of Shweta Arka Ksharaplota and to compare its efficacy with Apamarga kshara plota in the management of Kaphaja Dushta vrana Vis-à-vis Diabetic foot ulcer.
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
- 30.00 Year(s) 至 70.00 Year(s)(—)
入选标准
- •Irrespective of Gender, religion and occupation.
- •• Diagnosed cases of diabetic foot ulcers within 7 cm× 8 cm size (56 cm2 area) • Diabetic foot of grade 1 &2 as per Meggitt’s classification.
- •• Diabetic Foot Ulcers in controlled Diabetes Mellitus patients.
- •(HbA1c within 7%) • Subjects with Dorsalis Pedis Artery &Posterior Tibial Artery pulsations.
排除标准
- •• Patients Suffering from systemic disorders like Tuberculosis, uncontrolled HTN and HIV.
- •• Pregnant and lactating women.
- •• Wounds near major arteries and veins.
- •• Gangrenous ulcers, Tubercular ulcers, osteomyelitis and Ulcers with pre gangrenous changes.
结局指标
主要结局
OBJECTIVE PARAMETERS:
时间窗: 42 days
• Size of the wound
时间窗: 42 days
• Colour
时间窗: 42 days
• Discharge
时间窗: 42 days
• Odour
时间窗: 42 days
• Granulation tissue
时间窗: 42 days
• Itching
时间窗: 42 days
Subjects are assessed on the basis of subjective and objective parameters.SUBJECTIVE PARAMETERS:
时间窗: 42 days
• Pain
时间窗: 42 days
• Burning sensation
时间窗: 42 days
次要结局
- The intervention will be carried out until the attainment of Shuddhavrana(lakshanas.)
研究者
Dr SUSHMITHA M R
JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL MYSURU
