An Open Clinical Trial to evaluate the effectiveness of Siddha formulation Gowri Chinthamani Chendooram Internal and Karappan thylam External in the management of Karappan Eczema amoung outpatients attending Ayothidass Pandithar Hospital National Institute of Siddha Chennai 47
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction of 30% in clinical signs and symptoms of Karappan which is assessed by using Eczema Area And Severity Index (EASI)Score after treatment
研究概览
简要总结
Eczema is broadly applied to a range of persistent or recurring skin rashes characterized by redness, skin edema,
itching and dryness, with possible crusting, flaking, blistering, cracking, oozing or bleeding
• The lifetime prevalence of eczema is about 15-30% in children and 2-10% in adultsPRIMARY OBJECTIVE:
To evaluate the therapeutic effectiveness of siddha formulation Gowrichindamani chenduram (Internal) and Karappan thylam
(External medicine) in the management of Karappan (Eczema) by assessment of reduction in EASI Score among out-patients
attending Ayothidass Pandithar Hospital, National Institute of Siddha
SECONDARY OBJECTIVE :
To document the following parameters before and after treatment
•Changes in Complete Haemogram (Hb,total RBC,Total WBC, DC, Erythrocyte Sedimentation Rate)
•Changes in Liver function Test (Serum total bilirubin, Direct bilirubin, Indirect bilirubin, SGOT, SGPT, Alkaline
phosphatine, Gamma GT)
•Changes in Kidney Function Test( Blood urea,Serum creatinine )
•Changes in Lipid profile (Total cholesterol, TGL,HDL,LDL,VLDL)
•Changes in Absolute eosinophil count, IgE and siddha assessments
STUDY DESIGN: An open clinical trial
PRIMARY OUTCOME :
Significant reduction of 30% in clinical symptom which is assessed by using
Eczema Area and Severity Index after treatment.
SECONDARY OUTCOME :
The following parameters will be documented before and after treatment
changes in Complete Haemogram , Liver function Test ,Kidney
Function Test ,Absolute eosinophil count, IgE and siddha assessments.
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
- •Participants having signs and symptoms of Karappan.
- •Participants having duration of illness lesser than one month (acute Eczema).
- •Participants having EASI SCORE lesser than 51.
排除标准
- •Pregnant and Lactating.
- •Participants having secondary infection, bleeding disorder, diabetes mellitus, heart disease, tuberculosis,leprosy,scabies and psoriasis.
- •Participants having fasting blood glucose level greater than 200 mg/dl and post prandial blood glucose level greater than 300mg/dl.Known hypertensive participants with blood pressure level greater than 140/90mm Hg.
结局指标
主要结局
Reduction of 30% in clinical signs and symptoms of Karappan which is assessed by using Eczema Area And Severity Index (EASI)Score after treatment
时间窗: 3 months - patient screening. 7 months - patient enrollment. 2 month - outcome assessment.
次要结局
- The following data will be documented before and after treatment, Changes in complete haemogram, Total RBC, total WBC, DC, ESR) and Changes in liver function test (serum total bilirubin, direct bilirubin, indirect bilirubin, SGOT, SPOT, alkaline phosphatase and gamma GT)(3 months - patient screening . 7 months - patient enrollment. 2 months - outcome assessment)
研究者
Dr Yazhini S
National institute of siddha