Clinical study to evaluate the effect of Jalaukavacharana along with Patolakaturohinyadi kashaya and Triphala kashaya kshalana in Varicose eczema
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 1. To assess the effect of Jalaukavacharana along with Patolakaturohinyadi kashaya internally and Triphala kashaya kshalana in the management of Varicose eczema.
研究概览
简要总结
CLINICAL STUDY TO EVALUATE THE EFFECT OF JALAUKAVACHARANA ALONG WITH PATOLAKATUROHINYADI KASHAYA AND TRIPHALA KASHAYA KSHALANA IN VARICOSE ECZEMA
Skin diseases are the most common problem worldwide. Varicose Eczema is such an ailment which causes psychological, social and financial burden on patient and their families. It is a condition usually present secondary to varicose vein. There will be skin changes in lower limb as a result of stasis or pooling by gravitational collection of blood from insufficient venous return.
Objective of the study is to find the effect of Jalaukavacharana along with Patolakaturohinyadi kashaya and Triphala kashaya kshalana in reducing the signs and symptoms of Varicose Eczema.
Here the study designed as an interventional clinical trial without control group. All 32 subjects in this study will be given three sittings of Jalaukavacharana on 1st, 11th and 21st day along with
medications for a period of 21 days.
Medications include Patolakaturohinyadi kashaya 48 ml internally in morning and evening before food. Daily kshalana of the affected area will be done with Triphala kashaya.
Assessments will be done before and after treatment. Results will be analyzed statistically and conclusion will be drawn.
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
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of age group between 30-70 years irrespective of gender, religion, occupation and socio-economic status.
- •Subjects with signs and symptoms of Varicose eczema.
- •Subjects willing to sign the consent form.
排除标准
- •Subjects using anticoagulants and blood thinners.
- •Subjects having uncontrolled Diabetes Mellitus.
- •Subjects contraindicated for Rakthamokshana
- •Pregnant and lactating women.
结局指标
主要结局
1. To assess the effect of Jalaukavacharana along with Patolakaturohinyadi kashaya internally and Triphala kashaya kshalana in the management of Varicose eczema.
时间窗: 1. Clinical assessment of signs and symptoms of Varicose eczema will be done on 0th, 11th, 21st and 30th day. | Follow up will be done on 30th and 45th day. | 2. Assessment of severity of Varicose eczema in an individual using Patient-Oriented Eczema Measure (POEM) on 0th, 11th, 21st and 30th day. | 2. Assessment of the quality of life in an individual | using Dermatology Life Quality Index (DLQI) on 0th, 11th, 21st and 30th day.
2. To find out the effect of Jalaukavacharana along with Patolakaturohinyadi kashaya internally and Triphala kashaya kshalana in reducing signs and symptoms of Varicose eczema using Patient-Oriented Eczema Measure (POEM).
时间窗: 1. Clinical assessment of signs and symptoms of Varicose eczema will be done on 0th, 11th, 21st and 30th day. | Follow up will be done on 30th and 45th day. | 2. Assessment of severity of Varicose eczema in an individual using Patient-Oriented Eczema Measure (POEM) on 0th, 11th, 21st and 30th day. | 2. Assessment of the quality of life in an individual | using Dermatology Life Quality Index (DLQI) on 0th, 11th, 21st and 30th day.
3. To evaluate the effect of Jalaukavacharana along with Patolakaturohinyadi kashaya internally and Triphala kashaya kshalana in improving quality of life in Varicose Eczema using Dermatology life quality index (DLQI)..
时间窗: 1. Clinical assessment of signs and symptoms of Varicose eczema will be done on 0th, 11th, 21st and 30th day. | Follow up will be done on 30th and 45th day. | 2. Assessment of severity of Varicose eczema in an individual using Patient-Oriented Eczema Measure (POEM) on 0th, 11th, 21st and 30th day. | 2. Assessment of the quality of life in an individual | using Dermatology Life Quality Index (DLQI) on 0th, 11th, 21st and 30th day.
次要结局
- To evaluate the safety of Jalaukavacharana in subjects with Varicose eczema.(Haemoglobin & Erythrocyte Sedimentation Rate will be done to assess the safety.)
研究者
Dr N Madhuri Devi
Pankajakasthuri Ayurveda Medical College and Post Graduate Center