A Comparative Clinical Study To Evaluate The Efficacy Of Yakrit-16 Compound- Kwatha and Tablets (Kalpit Yoga) With And Without Kalpit Kalmeghadi Niruha Basti In The Management Of Yakrit Vikara w.s.r. to Alcoholic Fatty Liver Disease
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Significant improvement in the clinical symptoms of AFLD:
研究概览
简要总结
In this clinical trail, a total of 60 patients will be selected on the basis of signs and symptoms of Yakrit Vikara (Alcoholic Fatty Liver). These patients will be divided into 2 groups (Group A and Group B). Group A will be given Yakrit-16 Compound Kwatha and Tablets (Kalpit Yoga) and Kalpit Kalmeghadi Niruha Basti. Group B will be given only Yakrit-16 Compound Kwatha and Tablets (Kalpit Yoga). Hence the present study is undertaken to Evaluate the efficacy of Yakrit-16 Compound- Kwatha and tablets (Kalpit Yoga) with and without kalpit kalmeghadi niruha basti in the Management of Yakrit vikara w.s.r. to Alcoholic Fatty Liver Disease.
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
- 22.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Randomly selected irrespective of their caste, religion and sex.
- •b) Voluntary agreement & enrolment to participate in the study.
- •c) The ratio of AST/ALT below
- •d) Patients having alterations in Liver function tests with and without the symptoms of Kamala.
- •e) AFLD diagnosed by abdomen ultrasonic examination of fatty liver changes grade 1 and grade 2 only.
- •f) History of regular alcohol intake for at least 6 months.
排除标准
- •a) AFLD diagnosed by abdomen ultrasonic examination of fatty liver changes grade 3 or above.
- •b) Patients with fatty liver changes due to causes other than alcohol.
- •c) Patients with other illness such as uncontrolled Type I and II Diabetes Mellitus, Uncontrolled Hypertension, Cerebrovascular Accident, Myocardial Infarction and Chronic Kidney Disease, HIV, Tuberculosis, Malignancies, Major Psychiatric Problems or any other serious problems.
- •d) Patients having progressive stage of alcoholic liver disease like Hepatitis, Ascites, Cirrhosis, Cancer.
- •e) Patients on prolonged (more than 6 weeks) medication with corticosteroids, antidepressants, anti- cholinergic, hepato-toxic medicines or any other drug that may influence the outcome of the study.
- •f) Drug abuser.
- •g) Pregnant and Lactating women.
结局指标
主要结局
Significant improvement in the clinical symptoms of AFLD:
时间窗: Assessment will be done in both the groups: | 1. DAY 0- At the time of enrollment of the patient | 1.DAY 48th-At the end of the treatment (for Group A) | 2.DAY 45th-At the end of the treatment (for Group B)
i. Aruchi (Anorexia)
时间窗: Assessment will be done in both the groups: | 1. DAY 0- At the time of enrollment of the patient | 1.DAY 48th-At the end of the treatment (for Group A) | 2.DAY 45th-At the end of the treatment (for Group B)
ii. Avipaka (Indigestion)
时间窗: Assessment will be done in both the groups: | 1. DAY 0- At the time of enrollment of the patient | 1.DAY 48th-At the end of the treatment (for Group A) | 2.DAY 45th-At the end of the treatment (for Group B)
iii. Udarshula (Abdominal Pain)
时间窗: Assessment will be done in both the groups: | 1. DAY 0- At the time of enrollment of the patient | 1.DAY 48th-At the end of the treatment (for Group A) | 2.DAY 45th-At the end of the treatment (for Group B)
iv. Agnimandya (Diminution of the Agni)
时间窗: Assessment will be done in both the groups: | 1. DAY 0- At the time of enrollment of the patient | 1.DAY 48th-At the end of the treatment (for Group A) | 2.DAY 45th-At the end of the treatment (for Group B)
v. Utklesha (Nausea)
时间窗: Assessment will be done in both the groups: | 1. DAY 0- At the time of enrollment of the patient | 1.DAY 48th-At the end of the treatment (for Group A) | 2.DAY 45th-At the end of the treatment (for Group B)
vi. Chardi (Vomiting)
时间窗: Assessment will be done in both the groups: | 1. DAY 0- At the time of enrollment of the patient | 1.DAY 48th-At the end of the treatment (for Group A) | 2.DAY 45th-At the end of the treatment (for Group B)
次要结局
- Significant Improvement in the objective parameters:(1.Reduction in SGOT)
研究者
Dr Akshay Khanna
Dayanand Ayurvedic College, Jalandhar