The effect of SiraVedha at Dakshin Kurpar Sandhi in the management of Non Alcoholic Fatty Liver Diseases
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The primary objective is to study the effect of Sira Vedha at Right Elbow Joint in the management of Non-Alcoholic Fatty Liver Diseases as an adjuvant therapy.
研究概览
简要总结
Background: Sushrutaexplained the Sira Vedha at Dakshin Kurpara Sandhi (Right Elbow Joint) as aremedy for Yakrit Vikara (Liver Diseases), same treatment was explained bymodern science, but exact site was not mentioned. Similarly, the amount to bewithdrawn and interval also not revealed by previous researches. Although, inancient science, same was explained in the context, but lack clinical evidencesit was missing in mainstream. So, it is the need of time to study the principalof Sushruta regarding treatment of liver diseases.
Objective: Tostudy the effect of Sira Vedha at Dakshin Kurpara Sandhi (Right ElbowJoint) in the management of Non-Alcoholic Fatty Liver Diseases as an adjuvanttherapy
Material and Method: 120patients will be randomly allotted to Group A & Group B having 60 patientseach group. Group A will be treated with only lifestyle modification and dietregime and Group B, Sira Vedha with lifestyle modification and diet regime.Sira Vedha will be done at three times by the interval of fifteen days and LFT,lipid profile and CBC investigations will be carried out with respect toregular visit. Analysis will be done after the last visit of the patient forthe anticipative outcome of the Sira Vedha in present scenario.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria for the study include a) All patients irrespective of sex having age between 20 to 50 years with Non-Alcoholic Fatty Liver Disease (Grade I & Grade II fatty liver), b) able to give informed consent and willingness to participate in follow-up.
排除标准
- •Exclusion criteria for the study include- patients with carcinoma of liver, liver cirrhosis, HIV positive, HBsAg positive, terminal illness, pregnant and lactating lady, accidental cases, all types of anemias, Hemophilia, Thalassemia, case of poisoning, alcoholic liver diseases, eczema over Rt. elbow joint, skin diseases/ allergy, injury at right elbow joint.
结局指标
主要结局
The primary objective is to study the effect of Sira Vedha at Right Elbow Joint in the management of Non-Alcoholic Fatty Liver Diseases as an adjuvant therapy.
时间窗: Baseline 30th day 60th day
次要结局
- a) To study the effect of Sira Vedha at Right Elbow Joint on Liver Function, lipid profile, CBC count in Non-Alcoholic Fatty Liver Diseases in study group, b) To study the effect of Sira Vedha at Right Elbow Joint on Liver Function, lipid profile, CBC count in Non-Alcoholic Fatty Liver Diseases in control group, c) To compare the effect of Sira Vedha at Right Elbow Joint by evaluating the values of Liver Function, lipid profile, CBC count in study and control group.(Baseline 30th day 60th day)