A clinical study to evaluate the response of the Homoeopathic treatment in Chronic Venous diseases(CVD) in the lower limbs
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improved CVD and its complications and symptoms severity are assessed by grading systems using revised VCSS scores.
研究概览
简要总结
The presence of spider veins, varicose veins, oedema, skin hyperpigmentation, and venous ulcers in the affected areas characterizes the Chronic Venous Disease of lower limbs. Progressive venous insufficiency in a great saphenous vein (GSV) or small saphenous vein (SSV) is an underlying feature of these diseases.The condition of varicose veins has been defined as permanently dilated subcutaneous veins equal to or more than 3 mm in diameter in the upright position. Patients with varicose veins of the lower limbs typically present with abnormal sensation (itching, aching, tingling), leg pain, fatigue and heaviness, swelling, and restless leg syndrome with prolonged standing. These symptoms are associated with clinical signs, such as dilated tortuous veins (veins are twisted, swollen, and visible under the skin) and edema. Complications are leg ulcers, thrombophlebitis, and other pathological skin changes (e.g., Dermatitis)
The present study has been designed to ascertain the response to Homeopathy treatment CVD and its complications using standard parameters for assessment. The clinical hypothesis is that individualized Homoeopathic treatments can significantly decrease CVD and its complaints like cramps, itching, tortuosity of veins, and skin complaints (eczema, ulcer) , when measured on standardized scales (measured with the CEAP classification, Revised Venous Clinical Severity Score (VCSS), and improve quality of life by CIVIQ-14 self-assessment questionnaire
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •all genders.
- •Visible varicose veins with varicose or stasis eczema, varicose ulcer, itching, pain or heaviness, swelling in the lower limbs, 3)Venous disease was diagnosed by duplex ultrasonography.
排除标准
- •Pregnancy, lactation mother, secondary causes of chronic venous insufficiency or varicose veins (Abdominal tumors).
- •Any treatment for CVD over the last month.
- •If the Revised VCSS total score is between 25-
- •Participants who will not give consent for research.
结局指标
主要结局
Improved CVD and its complications and symptoms severity are assessed by grading systems using revised VCSS scores.
时间窗: baseline and monthly intervals for 12 months
次要结局
- A decrease in CEAP rating.(Improvement in participant quality of life score as measured by validated, CIVIQ-14)
研究者
Dr Dastagiri
National Homoeopathy Research Institute in Mental health
