A Comparative Clinical study to evaluate the Shodhana and Ropana effect of Sarjikadya Ghrita Ointment over Povidone Iodine Ointment in the Management of Dushta Vrana (Chronic Ulcers).
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assessment of objective parameters-
研究概览
简要总结
The word “Vrana” denotes “Vrana Gatra Vichurnane[1]” which means tissue disruption. Vrana cannot heal by itself when it is present in Dushta avastha hence Vrana Shodhana is done followed by Vrana ropana for healing of Dushta Vrana. . It can be clinically correlated to chronic ulcers based on lakshanas mentioned by Acharya.
An ulcer is defined as break in the continuity of the covering epithelium - skin or mucous membrane. It may either follow molecular death of the surface epithelium or its traumatic removal [2] and is usually seen affecting human beings at any age. In India a study conducted in 2018 estimated a prevalence rate of Chronic wounds at 4.5% per 1000 population [3]. In contemporary science procedures like Dressings, Topical Antimicrobials, Enzymes (Papain-Urea combinations) ,along with some advanced modalities like Negative pressure wound Therapy , Hyperbaric oxygen therapy, Acellular matrix tissues ,Bio-engineered Allogenic cellular therapies, Stem cell therapies , Hyalomatrix are used[4] but these interventions are not cost effective and not easily available.
According to estimation from the World Health Organization, 80% of the world’s population relies on traditional medicines for their Primary Healthcare [5]. The classical treatments for wound healing which are mentioned in Sushrut Samhita such as Shashti-Upakrama can help in treating Dushta Vrana. Application of Ghrita is one such form which is mentioned in Shashti Upakrama [6].
Sarjikadya Ghrita is Vrana Ropaka, Krimi-kanduhara and Savarnikarana. It is mentioned in Yoga Ratnakar. It contains drugs such as Yava Kshara and Sarjika Kshara which does Chedana, Bhedana and lekhana of Vrana and their Tridoshahara guna helps to remove unhealthy granulation tissue from Dushta vrana. Tankana, Sasyaka and Kampillaka have Antimicrobial property. Harenuka is known for wound healing properties. Sweta khadira present in formulation is known for its Kandughna and Savarnikarana karma. This formulation is told in the form of Ghrita in which Go-Ghrita is used to reduce pain, inflammation and burning sensation in Vrana. For the feasibility of application this Ghrita is further modified into ointment form to facilitate easy application .The ingredients present in this formulation are easily available and cost effective. Hence an attempt is made to evaluate the effect of Sarjikadya Ghrita in ointment form over Dushta Vrana.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Wound size upto 5x5x1 cm wound chronicity upto 2 yrs.
排除标准
- •ischaemic ulcer uncontrolled T2 Diabetes mellitus and hypertension HIV HCV and HbsAg positive patients patients with bleeding disorders.
结局指标
主要结局
Assessment of objective parameters-
时间窗: 4 weeks
Discharge
时间窗: 4 weeks
Size
时间窗: 4 weeks
Depth
时间窗: 4 weeks
Granulation Tissue
时间窗: 4 weeks
次要结局
- Assessment of-(pain)
研究者
Dr Chinmayee Sanjay Chamat
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal
