A Clinical Study of the effect and validation of Vranari Guggulu and Karanjadi Vranalepa in the management of Madhumeha janya vrana (Diabetic Foot Ulcer)management of Madhumehajanya Vrana (Diabetic Foot Ulcer)
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Relief in signs and symptoms, mean percentage change in wound area and pain.
研究概览
简要总结
The study used to check scientific validation of the clinical efficacy and safety of classical Ayurvedic formulation Vranari Guggulu and Karanjadi Vranalepa in Madhumehajanya Vrana (Diabetic Foot Ulcer) aIn the study Vranari Guggulu 500 mg twice daily internal administration and Karanjadi Vrana lepa as external application given for Group I patients (i.e. 50 patients), Kanchanara Guggulu 500 mg twice daily internal administration and Vajraka thailam as external application given for Group II patients (another 50 patients). The primary outcome measures will be relief in signs and symptoms, Mean percentage change in wound area, Recognized clinical prognostic factors like reduction in wound area, depth and wound healing. Proportion of patients with complete wound closure (i.e. complete skin epithelialization) after initiation of study treatment. Vranari Guggulu consists of pippali(piper logum) 1 part, guggulu(commiphora mukul)5parts, triphala each 3 parts, rasa sindura 1 part. Karanjadi vrana lepa consists of sasi(camphor) 1 part, Girivara 2 parts, Tutha(CuSo4) 3 parts, yashti(glycerrhiza) 4 parts, bakuchi(psoralia) 5 parts Karanja 6 parts.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of both sexes between the age group of 18-60 yrs.
- •2.Type I and II DM 3.After hematological examination Clinically Diagnosed confirmed as Diabetic Foot Ulcer 4.Chronic ulcer secondary to Diabetes of 30 days duration.
排除标准
- •1.H/o Infectious and systemic diseases 2.Ulcer on heel 3.Ulcer with exposed bone and tendon 4.Patients suffering with Immune deficiency 5.Coagulation disorders 6.Cellulitis 7.Gangrene 8.Presence of underlying Osteomyelitis 9.Pregnant women 10.Malignancies
- •Blood profiling done to exclude other diseases.
结局指标
主要结局
Relief in signs and symptoms, mean percentage change in wound area and pain.
时间窗: Treatment period 45 days, assessment for every week, active follow up visit on every week for 45 days.
complete wound closure is defined as skin re-epitheliazation without drainage or dressing requirment.
时间窗: Treatment period 45 days, assessment for every week, active follow up visit on every week for 45 days.
次要结局
- Improve general condition of the patient(wound healing)