Open Randomized Controlled Clinical Study To Evaluate The Efficacy Of Aksheevadi Ghrita Impregnated Tulle In the Management Of Sadyo Vrana W.S.R Surgical Wound
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the efficacy of Aksheevadi Ghrita impregnated tulle (AyuGras) in the management of Surgical wounds using REEDAs assessment scale which includes Pain Redness oedema ecchymosis discharge and approximation of surgical wound at day 1 day 3 day day 5 day 7 and day 10
研究概览
简要总结
Post-operative wound care is of prime importance after a successful operative procedure. In post-operative wound care the wound must be kept in a sterile environment as chance of infections are very high because of the exposed epithelium, as well as the granulation tissue needs to be kept under constant monitoring. Daily dressing and proper wound care is of prime importance in early stages as it helps in safer and faster healing. In modern practice we use dressing materials such as plain sterile gauzes, tulle gauzes impregnated with various anti-bacterial agents and ointments for local application.Each of the preparations and method of dressing
varies based on type, site and nature of pathogens, etc. involved in formation of wound.
Similarly in Ayurveda the concept of vikeshika has been mentioned for wound management but this does not have Krimighna property or anti-microbial property of its own. Merging the concept of vikeshika and Ghrita siddhi together we are making vikeshika impregnated with herbal medicated Ghrita that will be a ready formulation for dressing. Shigru and Yashtimadhu both plants have anti-bacterial, antifungal, anti-gastric, analgesic, anti-inflammatory, and wound healing properties and have been clinically proven in several research studies. Significant research on Shigru and Yashtimadhu has been conducted in the past but their role in wound care isn’t highlighted enough even after having all the successful qualities for wound care management, such as anti-bacterial, antifungal anti- inflammatory properties.
Hence, Method of preparation plays a crucial role in preparing a sterile dressing material especially in dressing of post operated wounds. We have hence tried to bridge the gap between modern and Ayurvedic system of medicine by preparing a herbal Ghrita impregnated sterile tulle for dressing of surgical wound which will be readily accepted due to its standardized method of preparation and sterility. The formulation will be sterile, disposable, cost effective & completely herbal preparation for surgical wound. The efficacy of this formulation (herbal impregnated tulle) will be assessed by using standard REEDs for surgical wound healing. It is an open randomized controlled clinical trial designed to evaluate the efficacy of the same.
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
- 18.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Wound type Sadyovrana 1 Aghataj Shuddha Vrana Traumatic non infected wounds (CLW size upto 6cm) Shastrakruta Vrana -Surgical wounds (minor surgical cases such as fissure lipoma cyst fistula dermoid cyst pedunculated growths etc) Other specifications Patient taken who will be operated under short GA local Saddle block Anesthesia.
排除标准
- •Patients having systemic disorders such as Diabetes Tuberculosis Leprosy Malignancies.
- •Immunocompromised patients diagnosed with HIV HBsAg HCV and VDRL positive.
- •Infected non healing wounds and burn wounds Patients with Venous Arterial ulcer (Vascular ulcer) pressure ulcers.
- •Wounds having deep tissue involvement like muscle bone tendon viscera.
- •Dropouts Patients discontinued follow up.
结局指标
主要结局
To assess the efficacy of Aksheevadi Ghrita impregnated tulle (AyuGras) in the management of Surgical wounds using REEDAs assessment scale which includes Pain Redness oedema ecchymosis discharge and approximation of surgical wound at day 1 day 3 day day 5 day 7 and day 10
时间窗: assessment of surgical wound healing REEDAs assessment scale at day 1 day 3 day day 5 day 7 and day 10
次要结局
- To provide sterile herbal dressing formulation in surgical wound management(by clinical prospective study assessing surgical wound healing using REEDAs assessment scale at day 1 day 3 day day 5 day 7 and day 10 and observing adverse effect of the formulation if any in the next 30 days)
研究者
Dr Usman Gani Aves Dhange
D.Y.Patil School of Ayurveda, Nerul, Navi Mumbai
