Open label clinical trial to study the efficacy of Nimbadi Kalka in Diabetic Foot Ulcer.
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- 1)Reduction in wound size assessed by wound tracing sheet
研究概览
简要总结
The research workentitled “Open Label Clinical Trial to Assess the Efficacy of NimbadiKalka in Diabetic Foot Ulcer†was carried out in the OPD and IPD ofAmrita School of Ayurveda and Amrita Institute of Medical Science, on 15patients. They were assessed on the basis of Pain, Granulation tissueformation, Exudate, and reduction in Wound Size on the 15th, 30th,and 45th day. Based on the study following conclusions can be drawn-
· NimbadiKalka possesses properties such as antioxidant,anti-inflammatory, and anti-microbial and it also maintains the moisture balance ofthe wound environment. These help in reducing the inflammatory phase of the chronic wound and thereby promotes the proliferation and remodeling phase.
· Ithas been proven beneficial in the reduction of exudate, pain, and wound size. Therewas 100% relief in pain, 95% reduction in exudate, and 88% in wound size, and after15 days of treatment, there is an improvement in granulation tissue formation.
· Also,the drug is easy to prepare and can be applied to any group of patients due toits better availability and safety.
· Noadverse drug reaction (ADR) and side effects were reported during the course oftreatment so the drug in the form of paste as the external or topical applicationis safe.
· Therefore,it may be recommended that this low-cost, easily prepared; an application may be prescribedfor routine use for wound healing purposes, especially in diabetic wounds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •HbA1c between 6-7 % 2)Wound penetrating to tendons associated with signs of infection (Texas B2 Classification) 3)Wound sites:- plantar surface of foot and toes (metatarsal heads and mid foot), dorsal interphalangeal joints.
排除标准
- •Age below 40 years and above 70 years 2)HbA1c above 7 3)More than B2 Texas classification 4)Wound anywhere except dorsal and plantar region 5)Patients with other systemic pathology (TB, HIV, HBsAg, VDRL, Malignancy) 6)Patient on other medications like steroids.
结局指标
主要结局
1)Reduction in wound size assessed by wound tracing sheet
时间窗: 45 days
次要结局
- 1)Effect on wound discharge assessed by the soak-age of gauze pad(2)Effect on granulation tissue formation assessed using photo documentation)
