Effect of Erandadighana vati over Kaishora guggulu after Virechan in the management of Vatarakta(Chronic Gout)- A randomised comparative clinical trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- •Improvement in the signs & symptoms (sandhi shotha(swelling)sandhi shola(pain), sparsh asahatvam (tenderness), twak vaivarnya(discolouration of skin), raga(redness), vidaha(burning sensation), stabdhata(stiffness)) of Vatarakta (Chronic Gout).
研究概览
简要总结
RESEARCH QUESTION: - In patients of 21-60 years What is the effect of Erandadi Ghana vati after Virechan over Kaishora guggulu after Virechan in the management of Vatarakta (Chronic Gout)?
HYPOTHESIS
Improvement in the cardinal symptoms of Vatarakta and decrease in Serum uric acid levels and improvement in the quality of life of patient by internal administration of Erandadi ghana vati after virechan in the management of Vatarakta(Chronic gout).
NULL HYPOTHESIS(H0)
Erandadi ghanavati is equally effective as Kaishora guggulu after Virechan in the management of Vatarakta (Chronic Gout).
ALTERNATE HYPOTHESIS(H1)
Erandadi ghanavati is not equally effective as Kaishora guggulu after virechan in the management of Vatarakta (Chronic Gout).
NEED FOR THE STUDY Many research works on Vatarakta reveals that the Ayurvedic treatment protocol is very effective in reducing the signs and symptoms of the patient by both sodhana and shamana.we have to explore the shamana medicines in the management of Vatarakta in the present era. To find a cost effective,easily available ,better efficacious shamana aushadha and shodhana in the management of Vatarakta we have to carry out the study. Here I am using erandadi ghanavati after Virechan and compare it with Kaishora guggulu after Virechana in the management of Vatarakta(Chronic Gout).
OBJECTIVE OF RESEARCH PROJECT
PRIMARY OBJECTIVES:
To improve the signs & symptoms (sandhi shotha(swelling ,sandhi shoola(pain), sparsh asahatvam (tenderness), twak vaivarnya(discolouration of skin), raga(redness), vidaha(burning sensation), stabdhata(stiffness)) of Vatarakta (Chronic Gout) and reduction in the level of serum uric acid in the patients having Vatarakta(Chronic Gout)
SECONDARY OBJECTIVES:
Improve the Quality of life of the patient (SF 36).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients presenting with the clinical features of Vatarakta (sandhi shotha(swelling), sandhi shola(pain), sparsh asahatvam (tenderness), twak vaivarnya(discolouration of skin), raga(redness), vidaha(burning sensation), stabdhata(stiffness)) 2.Patients either sex between age group of 21-60 yrs.
- •3.Patients showing the Serum uric acid level 7 -10mg/dl.
排除标准
- •1.Uncontrolled Diabetes and uncontrolled HTN 2.Subjects pre-diagnosed with autoimmune and infective disease of joints.
- •E.g. tuberculous arthritis 3.Malignancy 4.Genetic Disorder e.g. Duchene muscular dystrophy 5.Pregnant and lactating women 6.History of hypersensitivity to any of the trial drug ingredient.
结局指标
主要结局
•Improvement in the signs & symptoms (sandhi shotha(swelling)sandhi shola(pain), sparsh asahatvam (tenderness), twak vaivarnya(discolouration of skin), raga(redness), vidaha(burning sensation), stabdhata(stiffness)) of Vatarakta (Chronic Gout).
时间窗: BASELINE | AFTER 6 WEEKS | AFTER 12 WEEKS
次要结局
- Reduction in the level of serum uric acid in the patients having Vatarakta (Chronic Gout). (approx 25% improvement is expected)
研究者
Dr Priya goel
ALL INDIA INSTITUTE OF AYURVEDA