A Randomized controlled clinical study to evaluate the efficacy of local application of Vatajatankuradi Tail in the treatment of Sirajgranthi with special reference to Varicose veins of lower limbs.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Relief in signs and symptoms of varicose veins
研究概览
简要总结
Varicose veins is a condition affecting the lower limbs.In Addition of being a cosmetic issue,if not treated in a timely manner, it may result in serious complications like Eczema,Venous ulcers, Thromboplebitis ,Bleeding,etc. Varicosities can be treated surgically using a variety of techniques.Complications of Surgery are difficult to treat so apart from surgical interventions, safe treatment for Varicose veins (Siraj Granthi) should be done. Hence a Comprehensive holistic natural managementwhich aims at correcting the core pathology and preventing the prognosis is the need of the hour. Vatajatankuradi tail is patient friendly ,cost effective with no sideffects and gives symptomatic relierf preventing surgical consequences Total 80 cases will be selected by simple random sampling technique.Selected 80 cases will be divided in two groups i.e Grp A and Grp B. In Grp A Vatajatankuradi tail will be applied twice a for 6 weeks with followup after 15days for total 3 times. In Grp B Calcium Dobesilate ointment will be applied twice a day for 6 weeks with followup after 15 days for total 3 times.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient willing to participate in the study and those provide informed consent in written.
- •2.Patients with both Sex :Male and female 3.Patients diagnosed with Siraj granthi or varicose veins in lower extremity having clinical features -venous tortuosity, swelling ,pain and change in skin colour.
- •4.According to CEAP Classification patients till C5[skin changes with healed ulcers]and varicosity affecting Superficial veins will be included in this study.
排除标准
- •1.Patients those doesn’t give informed consent in written.
- •2.Patient with coagulopathy or bleeding diseases.
- •3.Known case of Varicosity associated with complications like deep vein thrombosis,calcification, equines deformity,venous ulcer.
- •4.According to CEAP Classification varicose ulcers, Congenital varicose veins and varicosity affecting deep and perforating veins will be excluded from this study.
结局指标
主要结局
Relief in signs and symptoms of varicose veins
时间窗: 45 days
次要结局
- Relief in Padashula, Padadaha, Padashotha, skin changes(45 days)