An open label controlled clinical trial to evaluate the effectiveness of arjuna taila in dushta vrana(varicose ulcer)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- •Bates Jensen wound assessment tool
研究概览
简要总结
Dushtavranaisa chronic type of wound resulted from varied aetiology. In contemporaryscience, it can be clinically correlated to chronic ulcers. Varicose ulcers areone among chronic venous ulcers. Venous ulceration is the most severe &debilitating outcome of chronic venous insufficiency in the lower limbswhich affects the quality of life of an individual by pain, itching, alteredappearance, loss of sleep, functional limitations. Venous disease isresponsible for around 85% of all chronic lower limb ulcers in resource-richcountries. Community based prevalence is 0.1-0.3% in adults(2-4% in elderly).The general line of treatment includes conservative approach such as Bisgaardmethod, compression therapy, vaccum assisted dressing, hyperbaric oxygen therapy,antibiotics, NSAIDs and surgical interventions like Thiersch grafting and laserablation have their own shortcomings. Nearly all venous ulcers can be healed,but even in those who have successful ablation or wear their stockingsreligiously, there is a 20–30% incidence of re-ulceration by 5 years.
Sushrutahas explained Shashti upakramain which specific avastha of vranachikitsa are highlighted. It includes shodhanartha& ropanartha upakrama like kashaya, varthi, kalka, sarpi, taila,rasakriya and avachurnana.Among them tailapossesskaphavatagna, vranashodhana,lekhana properties & areindicated in sadhyovrana, dushtavrana &dagdhavrana chikitsa.Lipid soluble drugs can penetrate more rapidly than water soluble drugs at thecell surface to enter into the circulation very quickly.
Arjunais mentioned as one among the drugs of Nyagrodadiganawhich is having kashayarasa, ruksha guna, sheetha virya and vranyaproperties whichcould be beneficial in dushtavrana.It has antioxidant, anti-inflammatory, analgesic, antimicrobial and antiviralproperties. Pre-clinical study conducted on topical applicationof Terminalia arjuna showedsignificant effect in histopathology and in wound healing.
Considering the above facts, anattempt is made to conduct clinical study aiming at establishing theeffectiveness of Arjuna taila in Dushtavrana (Varicose ulcer) chikitsa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patients diagnosed with varicose ulcer having the features of varicose vein& ulcer presenting with itching, pain, discharge and discolouration of surrounding tissue.
- •2.Subjects aged between 20-60 years irrespective of gender, religion, socio-economic status & place.
- •3.Ulcer size within 10cm x 10cm.
- •4.Chronicity of ulcer upto1year.
- •5.Subjects irrespective of chronicity of varicose veins.
排除标准
- •1.Patients aged above 60 years.
- •2.Patients with Deep vein thrombosis, malignancy, arterial diseases, bleeding disorders, cellulitis, gangrene & uncontrolled diabetes mellitus (HbA1c>6.5).
结局指标
主要结局
•Bates Jensen wound assessment tool
时间窗: Assessment will be done on 0th, 7th, 14th, 21st, 30th day limited to 30 days.
•VAS scale
时间窗: Assessment will be done on 0th, 7th, 14th, 21st, 30th day limited to 30 days.
•Itching
时间窗: Assessment will be done on 0th, 7th, 14th, 21st, 30th day limited to 30 days.
次要结局
- Quality of life(Assessment will be done on 0th, 7th, 14th, 21st, 30th day limited to 30 days.)
