Preclinical and clinical study of siddha drug "kukkil chooranam"(Internal medicine) and "thuvara ennai"(External medicine) in the treatment of pun (Naalavibatha pun- varicose ulcer)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction of varicose ulcer is assessed by Venous clinical severity score (VCSS) and reduction of associated symptoms of Varicose ulcer
研究概览
简要总结
It is a single non randomized, open label trial to determine the efficacy of kukkil chooranam(Internal) prepared by herbal and mineral constituents and thuvara ennai(External) in patients with nalavibatha pun9Varicose ulcer). In this trial 40 patients will be recruited and the trial drug will be administered 1gm twice a day with honey for a period of 48 days. during the trial period if any AE/SAE/SUSAR will be noticed and refered to pharmacovigilance in NIS and further management will also be given in NIS OPD/IPD. The entire trial will be monitored by the research monitoring committee of NIS. During this trial all the safety efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically. The outcome of this trial will be published in India jurnal of Medical research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
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.Presence of ulcers with varicose veins With or without Pain, Itching, Edema, Fibrinous exudates in the lesions 2.Hyper pigmentation 3.Eczema around the ulcer 4.Inflammation 5.Induration.
排除标准
- •1.Diabetes Mellitus 2.Hansen’s disease 3.Diabetic ulcer 4.Gangrene 5.Tuberculous ulcer 6.Any other systemic illness.
结局指标
主要结局
Reduction of varicose ulcer is assessed by Venous clinical severity score (VCSS) and reduction of associated symptoms of Varicose ulcer
时间窗: every 7 days for 3 months
次要结局
- Reduction of associated symptoms of Varicose ulcer(03 months)