A Comparative Clinical Study To Evaluate The Efficacy Of Giloy Swarasa With And Without Kaphahara Niruha Basti In The Management Of Yakrit Vikara W.S.R. To 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
- 60
- 试验地点
- 1
- 主要终点
- Significant improvement in the clinical symptoms of NAFLD:
研究概览
简要总结
In this clinical trial, total 60 patients will be selected on the basis of signs and symptoms of Yakrit Vikara (Non- alcoholic Fatty Liver Disease), these 60 patients will be divided into 2 groups (Group A and Group B). Group A will be given Kaphahara Niruha Basti along with oral administration of Giloy Swarasa. Group B will be given only Giloy Swarasa. In this study we will evaluate the efficacy of Giloy Swarasa in the management of Yakrit Vikara w.s.r. to Non-Alcoholic Fatty Liver Disease, To evaluate the efficacy of Kaphahara Niruha Basti followed by oral administration of Giloy Swarasa in the management of Yakrit Vikara w.s.r. to Non-Alcoholic Fatty Liver Disease and To compare the efficacy of Giloy Swarasa with and without Kaphahara Niruha Basti in the management of Yakrit Vikara w.s.r. to Non-Alcoholic Fatty Liver Disease with the aim of formulating an effective treatment module for this disease. Total duration of the study will be 18 months.
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients willing for study or trial.
- •2.Randomly selected irrespective of their caste, religion and sex.
- •3.Patients within the age group of 18-65 years.
- •4.Voluntary agreement & enrollment to participate in the study.
- •5.Patients who are fit for Basti Karma.
- •6.The ratio of AST/ALT below
- •7.Patients having alterations in Liver function tests with and without the symptoms of Kamala.
- •8.Non-alcoholic Fatty Liver Disease diagnosed by abdomen ultrasonic examination of fatty liver changes grade 1 and grade 2 only.
排除标准
- •1.Patients consuming alcohol.
- •2.Patients will be excluded from the study if they have chronic diseases such as bronchial asthma, cushing syndrome, malignancies, cerebrovascular accidents, myocardial infarction, chronic kidney disease or any liver dysfunction beyond non-alcoholic fatty liver disease.
- •Additionally, patients with HIV, tuberculosis, other infectious diseases, major psychiatric issues or metabolic syndromes will also be excluded.
- •3.Prior treatment with any medicine that affects the treatment of Non- Alcoholic Fatty Liver Disease within 3 months.
- •4.Patient on prolonged more than 6 weeks medication with corticosteroids, antidepressants, anticholinergic, hepato-toxic medicines or any other drug that may influence the outcome of the study.
- •5.Pregnant and Lactating women will be excluded.
- •6.The patient has a history of hypersensitivity to the trial drug or any of its ingredients.
- •7.Drug abusers.
结局指标
主要结局
Significant improvement in the clinical symptoms of NAFLD:
时间窗: Assessment will be done in both the groups: | 1.Day 0:At the time of enrollment. | 2.Day 20th:At the end of the Basti (for Group A). | 3.Day 48th:At the end of the treatment ( for Group A ). | 4.Day 45th:At the end of the treatment ( for Group B ). | 5.Day 60:At the time of follow up (for both the Groups A and B).
1.Aruchi (Anorexia)
时间窗: Assessment will be done in both the groups: | 1.Day 0:At the time of enrollment. | 2.Day 20th:At the end of the Basti (for Group A). | 3.Day 48th:At the end of the treatment ( for Group A ). | 4.Day 45th:At the end of the treatment ( for Group B ). | 5.Day 60:At the time of follow up (for both the Groups A and B).
2.Avipaka (Indigestion)
时间窗: Assessment will be done in both the groups: | 1.Day 0:At the time of enrollment. | 2.Day 20th:At the end of the Basti (for Group A). | 3.Day 48th:At the end of the treatment ( for Group A ). | 4.Day 45th:At the end of the treatment ( for Group B ). | 5.Day 60:At the time of follow up (for both the Groups A and B).
3.Udarshula (Abdominal pain)
时间窗: Assessment will be done in both the groups: | 1.Day 0:At the time of enrollment. | 2.Day 20th:At the end of the Basti (for Group A). | 3.Day 48th:At the end of the treatment ( for Group A ). | 4.Day 45th:At the end of the treatment ( for Group B ). | 5.Day 60:At the time of follow up (for both the Groups A and B).
4.Agnimandya (Diminution of the Agni)
时间窗: Assessment will be done in both the groups: | 1.Day 0:At the time of enrollment. | 2.Day 20th:At the end of the Basti (for Group A). | 3.Day 48th:At the end of the treatment ( for Group A ). | 4.Day 45th:At the end of the treatment ( for Group B ). | 5.Day 60:At the time of follow up (for both the Groups A and B).
5.Utklesha (Nausea)
时间窗: Assessment will be done in both the groups: | 1.Day 0:At the time of enrollment. | 2.Day 20th:At the end of the Basti (for Group A). | 3.Day 48th:At the end of the treatment ( for Group A ). | 4.Day 45th:At the end of the treatment ( for Group B ). | 5.Day 60:At the time of follow up (for both the Groups A and B).
6.Chardi (Vomiting)
时间窗: Assessment will be done in both the groups: | 1.Day 0:At the time of enrollment. | 2.Day 20th:At the end of the Basti (for Group A). | 3.Day 48th:At the end of the treatment ( for Group A ). | 4.Day 45th:At the end of the treatment ( for Group B ). | 5.Day 60:At the time of follow up (for both the Groups A and B).
次要结局
- Significant Improvement in Objective parameters:(1. Reduction in SGOT.)
研究者
Dr Simranjot Kaur
Dayanand Ayurvedic College