“CLINICAL EVALUATION OF ROHITAKABHAYA KWATHA IN NON-ALCOHOLIC FATTY LIVER DISEASE”
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Relief in subjective parameters:
研究概览
简要总结
This is an open label clinical study to evaluate Rohitakabhaya kwatha in Non Alcoholic fatty liver disease. It will be a clinical study of 30 patients suffering from Non alcoholic fatty liver disease. Patient will be selected randomly irrespective of their gender, race, religion, occupation. Patients with classical features of Yakritdalyodara attending the OPD/IPD of Kayachikitsa Department of Quadra Institute of Ayurveda and Hospital, Roorkee will be selected for this clinical study. The patients between the age group of 20-60 years of age will be selected. The assessment of the trial will be done on the basis of subjective and objective parameters. The period of study is 18 months and duration of study is 2 months. Data depending upon above subjective and objective criteria and other variables will be collected and analysed statistically.
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient having ultrasonographical evidence of NAFLD and BMI (25-40 Kg/m2).
- •Patient’s having altered serum liver enzymes levels defined as serum ALT and AST more than normal (>40 IU/L) but less than two times of the upper limit of the normal value(<80 IU/L).
- •Subjects of either sex, age group 20-60 years who are non-alcoholics or they have history of alcohol intake less than 20 g/day.
排除标准
- •Patients who is unwilling to participate in study.
- •Patients having serum liver enzymes AST and ALT more than 2 times of upper normal limit.(i.e.AST more than 76 U/L; ALT more than 82 U/L)
- •Patients having ultrasonographical evidence of cirrhosis or necrosis of liver.
- •Patient who is consuming alcohol.
- •Patient testing positive for hepatitis B & hepatitis C, uncontrolled diabetes, malignancy of liver or having any other comorbidity.
结局指标
主要结局
Relief in subjective parameters:
时间窗: First assessment 15 days post- treatment initiation. | Second Assessment- 15 days after the first assessment. | Third Assessment- 15 days after the second assessment.
1.Utklesha
时间窗: First assessment 15 days post- treatment initiation. | Second Assessment- 15 days after the first assessment. | Third Assessment- 15 days after the second assessment.
2. Chardi
时间窗: First assessment 15 days post- treatment initiation. | Second Assessment- 15 days after the first assessment. | Third Assessment- 15 days after the second assessment.
3. Aruchi
时间窗: First assessment 15 days post- treatment initiation. | Second Assessment- 15 days after the first assessment. | Third Assessment- 15 days after the second assessment.
4. Hridkantadaha
时间窗: First assessment 15 days post- treatment initiation. | Second Assessment- 15 days after the first assessment. | Third Assessment- 15 days after the second assessment.
5. Udarashoola
时间窗: First assessment 15 days post- treatment initiation. | Second Assessment- 15 days after the first assessment. | Third Assessment- 15 days after the second assessment.
次要结局
- Relief in objective parameters:(1. Anthropometric measurements - Body weight, BMI)
研究者
Dr Charu Sharma
Quadra Institute of Ayurveda and Hospital Roorkee Haridwar